Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF APRIL 22, 2021 SAM #7082
SOLICITATION NOTICE

65 -- EXAM GLOVES, NITRILE - VARIOUS SIZES

Notice Date

4/20/2021 12:09:19 AM
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

339113 — Surgical Appliance and Supplies Manufacturing
 

Contracting Office

DLA TROOP SUPPORT PHILADELPHIA PA 19111 USA
 

ZIP Code

19111
 

Solicitation Number

SPE2DS21R0003
 

Response Due

1/5/2021 12:00:00 PM
 

Archive Date

04/21/2021
 

Point of Contact

ABIN MATHAI, Phone: 2157378790, Brian C. Schott, Phone: 2157372121
 

E-Mail Address

ABIN.MATHAI@DLA.MIL, brian.schott@dla.mil
(ABIN.MATHAI@DLA.MIL, brian.schott@dla.mil)
 

Description

update 4/20/21 -�solicitation (RFP) SPE2DS21R0003, originally published back on December 22, 2020 with formal closing date of January 5, 2021, is being cancelled in its entirety. It is has been determined that is no longer in the best interest of the government to further proceed.� //////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////////// FAR Part 12 procedures apply to this solicitation.� �� PROMPT PAY PROCEDURES WILL APPLY TO ANY FORTH COMING AWARD ACTION AGAINST THE SUBJECT SOLICITATION�S REQUIREMENTS. Subject acquisition is hereby being issued as �UNRESTRICTED� and is also being issued to solicit for �Request for Proposals� (RFPs).� ************************************************************************************************************************************************ NOTE:� Please be advised that this Purchase Order is Prompt Pay. Fast Pay procedures do not apply. All invoices must be submitted on WAWF (WIDE AREA WORKFLOW) as ""Invoice only"". Once material is receipted, the invoice will process for payment in 30 days. Vendors will be required to provide the acquisition specialist and contracting officer with bill of lading documents as well as proof of deliveries prior to and after shipment of material to the above mentioned SNS facilities. �� --------------------------------------------------------------------------------------------------------------� �� � Block 9: Submission Instructions 1. All offers shall be submitted via email to Abin.Mathai@dla.mil and Brian.Schott@dla.mil. For larger e-mails, typically greater than 5MB, either submit in a single email using Zip files, in multiple, numbered emails, or coordinate with Abin Mathai and Brian Schott prior to submittal in order for DLA to set up a vendor DoD SAFE account via https://safe.apps.mil/ ahead of time for large document uploads. Please note you will need an email invite from DLA to be able to upload submissions to DoD SAFE. If you have any questions you may contact Abin Mathai at Abin.Mathai@dla.mil or Brian Schott at Brian.Schott@dla.mil. If the offer is submitted by email or DoD SAFE submissions, all emails / submissions must be received by the date and time established for receipt of offers in order to be considered timely. 2. Electronic submissions must use Microsoft Word, Adobe PDF, and/or Microsoft excel formats. 3. Vendors may revise or withdraw their offer up to the closing date cited under this solicitation. 4. Offer must be valid for 90 days after the closing date. � � � � Solicitation Number: SPE2DS-21-R-0003 � � � � � �� Opening/Closing Date and Time: �12/22/2020 / 12/30/2020 03:00PM EST 5. �Blocks 19-22� �� Item No., Schedule of Supplies/Services, Quantity, Unit: �� �SCHEDULE OF SUPPLIES/SERVICES General Product description: A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand �to prevent contamination between patient and examiner. Products sought include examination gloves that are nitrile, non-sterile, powder-free, ambidextrous, and not made with natural rubber latex in various sizes �ranging from Small (SM), Medium (MED), Large (LG), and Extra Large (XL).� �� ITEM NO. �- 0001� ITEM IDENTIFICATION: �EXAM GLOVES, NITRILE - SIZE SMALL � �� QUANTITY - 1,000,000 BXs (1 BOX = 100EA) � this is the advertised Unit of Issue/Unit of Measure � The only UOM being considered is 100EA per glove carton. �Refer to specifications on pages 8 and 9. UNIT PRICE� $_______________ � �(Price shall be F.O.B. Destination) �///////////////////////////////////////////////////////////// ITEM NO. �- 0002� ITEM IDENTIFICATION: �EXAM GLOVES, NITRILE - SIZE MEDIUM� � �� QUANTITY - 4,000,000 BXs (1 BOX = 100EA) � this is the advertised Unit of Issue/Unit of Measure � The only UOM being considered is 100EA per glove carton. �Refer to specifications on pages 8 and 9. UNIT PRICE� $_______________ � �(Price shall be F.O.B. Destination) //////////////////////////////////////////////////////////// ITEM NO. �- 0003� ITEM IDENTIFICATION: �EXAM GLOVES, NITRILE - SIZE LARGE �� QUANTITY - 4,000,000 BXs (1 BOX = 100EA) � this is the advertised Unit of Issue/Unit of Measure � The only UOM being considered is 100EA per glove carton. �Refer to specifications on pages 8 and 9. UNIT PRICE� $_______________ � �(Price shall be F.O.B. Destination) /////////////////////////////////////////////////////////// ITEM NO. �- 0004� ITEM IDENTIFICATION: �EXAM GLOVES, NITRILE - SIZE X-LARGE � �� QUANTITY - 1,000,000 BXs (1 BOX = 100EA) � this is the advertised Unit of Issue/Unit of Measure � The only UOM being considered is 100EA per glove carton. �Refer to specifications on pages 8 and 9. � � UNIT PRICE� $_______________ � �(Price shall be F.O.B. Destination) ///////////////////////////////////////////////////////////// ITEM NO. �- 0005� ITEM IDENTIFICATION: �EXAM GLOVES, NITRILE - SIZE SMALL � �� QUANTITY - 500,000 BXs (1 BOX = 100EA) � this is the advertised Unit of Issue/Unit of Measure � The only UOM being considered is 100EA per glove carton. �Refer to specifications on pages 8 and 9. UNIT PRICE� $_______________ � �(Price shall be F.O.B. Destination) ///////////////////////////////////////////////////////////// ITEM NO. �- 0006� ITEM IDENTIFICATION: �EXAM GLOVES, NITRILE - SIZE MEDIUM� � �� QUANTITY - 2,000,000 BXs (1 BOX = 100EA) � this is the advertised Unit of Issue/Unit of Measure � The only UOM being considered is 100EA per glove carton. �Refer to specifications on pages 8 and 9. UNIT PRICE� $_______________ � �(Price shall be F.O.B. Destination) //////////////////////////////////////////////////////////// ITEM NO. �- 0007� ITEM IDENTIFICATION: �EXAM GLOVES, NITRILE - SIZE LARGE � �� QUANTITY - 2,000,000 BXs (1 BOX = 100EA) � this is the advertised Unit of Issue/Unit of Measure � The only UOM being considered is 100EA per glove carton. �Refer to specifications on pages 8 and 9. UNIT PRICE� $_______________ � �(Price shall be F.O.B. Destination) //////////////////////////////////////////////////////////// ITEM NO. �- 0008� ITEM IDENTIFICATION: �EXAM GLOVES, NITRILE - SIZE X-LARGE � �� QUANTITY - 500,000 BXs (1 BOX = 100EA) � this is the advertised Unit of Issue/Unit of Measure � The only UOM being considered is 100EA per glove carton. �Refer to specifications on pages 8 and 9. UNIT PRICE� $_______________ � �(Price shall be F.O.B. Destination) //////////////////////////////////////////////////////////// ITEM NO. �- 0009� ITEM IDENTIFICATION: �EXAM GLOVES, NITRILE - SIZE SMALL � �� QUANTITY - 500,000 BXs (1 BOX = 100EA) � this is the advertised Unit of Issue/Unit of Measure � The only UOM being considered is 100EA per glove carton. �Refer to specifications on pages 8 and 9. UNIT PRICE� $_______________ � �(Price shall be F.O.B. Destination) //////////////////////////////////////////////////////////// ITEM NO. �- 0010� ITEM IDENTIFICATION: �EXAM GLOVES, NITRILE - SIZE MEDIUM� � �� QUANTITY - 2,000,000 BXs (1 BOX = 100EA) � this is the advertised Unit of Issue/Unit of Measure � The only UOM being considered is 100EA per glove carton. �Refer to specifications on pages 8 and 9. UNIT PRICE� $_______________ � �(Price shall be F.O.B. Destination) //////////////////////////////////////////////////////////// ITEM NO. �- 0011 ITEM IDENTIFICATION: �EXAM GLOVES, NITRILE - SIZE LARGE � �� QUANTITY - 2,000,000 BXs (1 BOX = 100EA) � this is the advertised Unit of Issue/Unit of Measure � The only UOM being considered is 100EA per glove carton. �Refer to specifications on pages 8 and 9. UNIT PRICE� $_______________ � �(Price shall be F.O.B. Destination) //////////////////////////////////////////////////////////// ITEM NO. �- 0012 ITEM IDENTIFICATION: �EXAM GLOVES, NITRILE - SIZE X-LARGE � �� QUANTITY - 500,000 BXs (1 BOX = 100EA) � this is the advertised Unit of Issue/Unit of Measure � The only UOM being considered is 100EA per glove carton. �Refer to specifications on pages 8 and 9. . UNIT PRICE� $_______________ � �(Price shall be F.O.B. Destination) //////////////////////////////////////////////////////////// CAUTION NOTICE 1. The Government will not make partial payments, progress payments, advance payments, or loan guarantees to the contract awardee(s). �No financing will be provided by the Government to the awardee(s). �Instead, the Government will make payment to the awardee(s) after delivery, following the Wide Area Workflow (WAWF) procedures described in the Solicitation. 1A. Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment As part of their response to this solicitation, offerors are required to provide representation to FAR 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment; FAR 52.204-26, Covered Telecommunications Equipment or Services � Representation; DFARS 252.204-7016, Covered Defense Telecommunications Equipment or Services � Representation; and DFARS 252.204-7017 Prohibition on the Acquisition of Covered Defense Telecommunications Equipment or Services�Representation. These representations are found in full text in the Solicitation below. 2. Subcontracting Plan All large business offerors must submit a subcontracting plan with their offer. �Instructions for submitting the subcontracting plan are included in FAR 52.212-1. Contractors are required to report progress on subcontracting goals to the electronic Subcontracting Reporting System (eSRS) twice a year. eSRS is an internet-based tool that streamlines the process of reporting on subcontracting plans and provides agencies with access to analytical data on subcontracting performance. More information on eSRS can be found at DGPA 19.7:� https://dlamil.dps.mil/:w:/r/sites/TrpSupport/_layouts/15/doc2.aspx?sourcedoc=%7BC99F8DE5-140A-4CDB-BDE0-B1355FF9D407%7D&file=Part%2019%20-%20Small%20Business%20Programs.docx&action=default&mobileredirect=true&cid=db98ce88-9c03-4845-8f86-62cb6f56f72c 3. Contractor Code of Business Ethics FAR Part 3.1002(a) requires all government contractors to conduct themselves with the highest degree of integrity and honesty. �Contractors should have a written code of business ethics and conduct within thirty days of award. �To promote compliance with such code of business ethics and conduct, contractors should have an employee business ethics and compliance training program that facilitates timely discovery and disclosure of improper conduct in connection with government contracts and ensures corrective measures are promptly instituted and carried out. �A contractor may be suspended and/or debarred for knowing failure by a principal to timely disclose to the government, in connection with the award, performance, or closeout of a government contract performed by the contractor or a subcontract awarded there under, credible evidence of a violation of federal criminal law involving fraud, conflict of interest, bribery, or gratuity violations found in title 18 of the United States Code or a violation of the False Claims Act. �(31 U.S.C. 3729-3733) If this solicitation or contract includes FAR clause 52.203-13 - CONTRACTOR CODE OF BUSINESS ETHICS AND CONDUCT; the contractor shall comply with the terms of the clause and have a written code of business ethics and conduct; exercise due diligence to prevent and detect criminal conduct; promote ethical conduct and a commitment to compliance with the law within their organization; and timely report any violations of federal criminal law involving fraud, conflict of interest, bribery or gratuity violations found in title 18 of the United States Code or any violations of the False Claims Act. �(31 U.S.C. 3729-3733). �When FAR 52.203-13 is included in the contract, contractors must provide a copy of its written code of business ethics and conduct to the contracting officer upon request by the contracting officer. 4. Wide Area Workflow (WAWF ) The Department of Defense is mandating use of the Wide Area Work Flow (WAWF). The contract awardee WILL BE REQUIRED to use WAWF. Wide Area Workflow is a secure Web-based system for electronic invoicing, receipt and acceptance. WAWF creates a virtual folder to combine the three documents required to pay a Vendor - the Contract, the Invoice, and the Receiving Report. The WAWF application enables electronic form submission of Invoices, government inspection, and acceptance documents in order to support DoD's goal of moving to a paperless acquisition process. WAWF helps to mitigate interest penalty payments due to lost or misplaced documents and highlights Vendor offered discounts so that the DoD benefits on both fronts, in addition to streamlining the whole process from weeks to days or minutes. 5. All offerors shall provide a written certification that they shall fully comply with all the solicitation requirements and are not taking exception to any terms or conditions. �With its offeror, each offeror must submit as a separate document certification stating as follows: �[Offeror ABC] shall fully comply with all solicitation requirements and is not taking exception to any terms or conditions.� �The certification must be signed by a representative of the offeror and dated. 6. Trade Agreements Act This acquisition is subject to the Trade Agreements Act (TAA) and the regulations implementing it. This solicitation includes DFARS provision 252.225-7020, Trade Agreements Certificate � Basic, and DFARS clause 252.225-7021, Trade Agreements � Basic. Consistent with DFARS 252.225-7020 and DFARS 252.225-7021, in the space below, specify the Country of Origin for each CLIN (specify the Country of Origin even if the offered product is a U.S.-made, qualifying country, or designated country end product): Country of Origin : CLIN 0001 ________________� CLIN 0002 ________________ CLIN 0003 ________________ CLIN 0004 ________________ CLIN 0005 ________________� CLIN 0006 ________________ CLIN 0007 ________________ CLIN 0008 ________________ CLIN 0009 ________________� CLIN 0010 ________________ CLIN 0011 ________________ CLIN 0012 ________________ STATEMENT OF WORK� 1. Background The mission of the Division of Strategic National Stockpile (DSNS), of the United States (U.S.) Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR), is to ensure the availability and rapid deployment of life-saving pharmaceuticals, antidotes, other medical supplies, and equipment necessary to counter the effects of biological, chemical, radiological, natural disasters or other emerging infectious disease agents. When state, local, tribal, and territorial public health and medical systems request federal assistance to support their response efforts, DSNS ensures that the right medicines and supplies get to those who need them most during a public health emergency or pandemic event. The Strategic National Stockpile (SNS) is a national repository of pharmaceuticals, vaccines, medical supplies, and medical equipment stored in strategic locations around the nation. These assets are designed to supplement state and local public health departments in the event of a large-scale public health emergency that causes local supplies to run out.� Protection of healthcare workers and first responders from transmission of pathogens is essential to maintaining resilience of the U.S. healthcare system. EXAMINATION GLOVES, NITRILE �are one part of an infection control strategy and are examples of personal protective equipment (PPE) that is a disposable device intended for medical purposes that is worn on the examiner�s hand or finger to prevent contamination between patient and examiner. The appropriate use of PPE is an important component of the overall strategy of certain infection control guidelines. II. Contract Scope� DLA-Troop Support Medical Directorate will award multiple Firm Fixed Price (FFP) contracts as a result of this solicitation for EXAMINATION GLOVES, NITRILE - in the following four (4) sizes - Small, Medium, Large and X-Large. The total required quantity is 2 BILLION gloves (EA) split among the four size categories referenced below. The REQUIRED UNIT OF MEASURE is 100 gloves per box.� The Government will make a MINIMUM of 2 awards encompassing the 12 CLINS (and 3 SNS locations) identified below. The Government MAY award more than 1 award for each CLIN, in accordance with the Lowest Price Technically Acceptable selection procedure. In order to be considered technically acceptable an offeror must quote on a MINIMUM OF 250 MILLION Gloves, up to a maximum of 1 billion gloves. The overall requirement is 2 Billion total gloves. DLA Troop Support requires that a MINIMUM OF 50 PERCENT of the quantity offered MUST be delivered within 45 days after award WITH the remainder of the quantity of the award to be delivered 75 days after award. An offeror who takes exception to the delivery terms may be deemed technically unacceptable. The Government reserves the right to make an award on any item for a quantity less than the quantity offered, at the unit prices offered, if in accordance with Lowest Price Technically Acceptable evaluation procedures. � 1 BILLION eaches (EA) gloves will be delivered to the following location in the following qty and size breakout: SMALL: 100 Million EAs �(1M BXs of 100EA) - CLIN 0001 MEDIUM: 400 Million EAs �(4M BXs of 100EA) - CLIN 0002 LARGE: 400 Million EAs (4M BXs of 100EA) - CLIN 0003 EXTRA LARGE: 100 Million �EAs (1M BXs of 100EA) - CLIN 0004 LifeScience Logistics 4993 Anson Blvd Whitestown, IN 46076 POC Jeremy Echerd Mobile: 404-852-2657 Email: vhd9@cdc.gov ////////////////////////////////////////////////////////////////////////////////////////////////////////////// 500 Million eaches (EA) gloves will be delivered to the following location in the following qty and size breakout: SMALL: 50 Million EAs �(500K BXs of 100EA) - CLIN 0005 MEDIUM: 200 Million EAs �(2M BXs of 100EA) - CLIN 0006 LARGE: 200 Million EAs (2M BXs of 100EA) - CLIN 0007 EXTRA LARGE: 50 Million �EAs (500k BXs of 100EA) - CLIN 0008 Metro Logics � � � � � � � � � � � � � � � � � � 12121 Forest Park Dr., Suite 100,� Olive Branch, MS 38655 POC Blair Sneed Mobile: 678-427-5844 Email: bkx4@cdc.gov /////////////////////////////////////////////////////////////////////////////////////////////////////////// 500 Million eaches (EA) gloves will be delivered to the following location in the following qty and size breakout: SMALL: 50 Million EAs �(500K BXs of 100EA) - CLIN 0009 MEDIUM: 200 Million EAs �(2M BXs of 100EA) - CLIN 0010 LARGE: 200 Million EAs (2M BXs of 100EA) - CLIN 0011 EXTRA LARGE: 50 Million �EAs (500k BXs of 100EA) - CLIN 0012 Integrated Quality Solutions � � �� 1790 S 4800 W, � � � � � � � � � � � � � � � � � � � � � � � � � � � � Salt Lake City, UT 84104 POC Francisco Reyes Mobile: 404-556-4078 Email: vqw1@cdc.gov /////////////////////////////////////////////////////////////////////////////////////////////////////// III. SPECIFICATIONS The vendor shall supply EXAMINATION GLOVES, NITRILE with the following characteristics: As these products may be stockpiled, the regulatory flexibility described in the FDA enforcement policy for gloves that is in effect during the COVID-19 public health emergency DOES NOT APPLY. Examination gloves are required to meet the requirement outlined in 21 CFR 880.6250 to include premarket notification. �Proof of 510(K) clearance must be submitted with the vendor proposal. Examination gloves are required to meet the general controls specified in the Medical Device Amendments of the Food, Drug and Cosmetic Act to include registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration. Minimum Requirements: 1. Vendor must offer commercially available products for all items offered� 2. Vendor must provide product catalog & literature for any items offered. Vendor must submit the following information: Full item description, Product images, Glove Color, Distributor Part Number, Manufacturer Part Number, Manufacturer Name, and Number of eaches in Unit of Sale. Supporting documentation must be in form of commercially available catalogs and product literature (e.g. brochures, user manuals, product packaging, product specification sheets, product images, etc.). �NO BLACK NITRILE GLOVES WILL BE CONSIDERED. �OTHER COLORS WILL BE CONSIDERED. 3. Vendor must provide Nitrile Examination Gloves that are FDA cleared and provide 510(K) documentation, FDA approval number, and FDA Registration number to support this.� FDA has advised that changing the color of a 510(k)-cleared glove requires a new 510(k) submission, in part because a new color additive can potentially change the biocompatibility of the glove. We�ve also included an excerpt below from the Guidance for Industry and FDA Staff: Medical Glove Guidance Manual https://www.fda.gov/media/90612/download� PRODUCT MODIFICATIONS : If you make a change to your gloves that significantly affects safety or effectiveness of the gloves, you must submit a new and complete 510(k) (21 CFR 807.81(a)(3)). Examples of changes that may require a new 510(k) include adding or deleting powder; adding color, fragrance, or a claim to the labeling; or modifying an important process. FDA usually does not require a new 510(k) if a manufacturer only does more of an existing process, such as extra leaching or washing, and makes no claim or mention of this change on the product labeling. 4. Vendor must provide a letter of manufacturer relationship if not clearly stated in the FDA 510(k) 5. Vendor�s Nitrile glove color must be the same as listed in the 510(k) approval documentation 6. Vendor must provide Nitrile Examination Gloves that meet the ASTM D6319 (Standard Specification for Nitrile Examination Gloves for Medical Application) and provide documentation and test reports to support this. Test reports must include glove length, finger and palm thickness, tensile strength, elongation (unaged and aged) and Acceptable Quality Level for holes. a. Vendor must provide Nitrile Exam Gloves products with length of at least 9 inches and no more than 10 �inches and provide documentation to support this.� b. Vendors much provide Nitrile Exam Gloves products with 2.8 mil up to 8 mil finger thickness and provide documentation to support this.� Please refer to the below FDA information from the link provided. � � � (2) Sample sizes, inspection levels, and minimum AQLs. FDA will use single normal sampling for lots of 1,200 gloves or less and multiple normal sampling for all larger lots. FDA will use general inspection level II in determining the sample size for any lot size. As shown in the tables following paragraph (c)(3) of this section, FDA considers a 1.5 AQL to be the minimum level of quality acceptable for surgeons' gloves and a 2.5 AQL to be the minimum level of quality acceptable for patient examination gloves. For sampling sizes refer to the table, in link above, located under Accept/Reject Criteria at 2.5 AQL for Patient Examination Gloves https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=800.20 7. Vendor test reports for ASTM D6319 must be from a third party accredited ISO 17025 laboratory.� 8. Vendor must provide Nitrile Examination Gloves products that are ambidextrous with textured finger tipsand provide documentation to support this. � 9. Vendor must provide Nitrile Examination Gloves products that are not made with natural rubber latex. Vendor must also provide submittal documentation establishing that the offered products are not made with natural rubber latex. The vendor must meet this requirement in one of three ways: 1) demonstrating that the labeling for the offered products contains the FDA recommended statement ""Not made with natural rubber latex,"" 2) demonstrating that the ISO BS EN 15223-1:2016 symbol [reference number 5.4.5] is on the labeling for the offered products, or 3) if the product labeling does not contain the FDA recommended statement or the ISO BS EN 15223-1:2016 symbol [reference number 5.4.5], the vendor must provide a signed letter stating that the offered products are ""not made with natural rubber latex."". 10. Vendor must provide Nitrile Exam Glove products with the following characteristics documented on the individual product box indicated in a statement or by the ISO BS EN 15223-1:2016 symbol(s), and provide documentation to support this: � � � � � � � � �a.�� �Powder-free � � � � � � � � �b.�� �Single use, disposable � � � � � � � � �c.�� �Non-sterile � � � � � � � � �d.�� �Ambidextrous 11. Vendor must provide Nitrile Exam Gloves with standard commercial box packaging of 100 gloves or 50 pairs in order to fit most standard gloves dispenser units and documentation to support this.� 12. FDA labeling requirements for both glove carton and outer case must be consistent with that reviewed by the FDA for the Vendor�s 510(k) clearance, and must minimally include the following FDA labeling: a. Labeling to be included on both glove carton and outer case: � � � � � � � � � i. Name and Place of Business, including the Country of Origin � � � � � � � � � ii.�� �Identity of the Product (e.g. nitrile examination gloves) � � � � � � � � � iii.�� �Size� � � � � � � � � �iv.�� �Net Quantity � � � � � � � � � v.�� �Direction for Use (e.g. disposable/single use)� � � � � � � � � �vi. Intended use/indications for use (on carton and or outer case) � � � � � � � � �vii. Statements of all purposes for which and conditions under which � � � � � � � � � � � �the device can be used and the conditions under which the device � � � � � � � � � � � cannot be use. For example, a warning statement � � � � � � � � �viii. Manufacturer lot� � � � � � � � � � iix. Unique Device Identification number (per 21 CFR 830 and 801.20) for class II devices, and after � � � � � � � � � � � � � � �September 24, 2022, class I devices. �The statement was provided for vendor reference so they could� � � � � � � � � � � � �see that UDI was not a requirement for Class 1 until then � � � � � � � � � �x. All labeling must be provided in English � � � � � � � � �xi.�� �Use of symbols must be in compliant with 21 CFR Part 801.15 � � � � � � � �b. Product part/item number, and date of manufacture and / or expiration date must be included on the glove carton and outer casing 13. �Images of product outer case labeling and inner carton labeling (all sides) and outer case labeling 14. Sizes to include small, medium, large, extra large. 15. Vendors must disclose any regulatory mechanisms (FDA EUA, FDA Enforcement Policy) required for product use. Products being used under an FDA Enforcement Policy or Emergency Use Authorization will not be considered. 16. Standard U.S. commercial packaging requirements apply. �The intent of this statement is to ensure that gloves come packaged in inner cartons (eg 100ea/carton) with x amount of inner cartons in a case as per industry. 17. �Any incomplete proposal submission will not be considered. Shipping Requirements: � At time of delivery to the Government, the Contractor shall provide shelf life or expiiring dating data. � No mixed lot numbers per case or per packages will be accepted. � One lot number will be used per pallet. The last pallet may contain multiple lot numbers per order. � Lots must be clearly identified.� � All shipments will include packing slips which should list the contract number, item description, NDC or part number, lot numbers, quantities and storage requirements.� � Contractor shall contact designated POC (for the respective address that product is being delivered to), to schedule delivery appointments, 48 hours prior to shipping any product (delivery timeframe is Mon � Fri, 8:00 AM � 3:30 PM). � For products with an issued NSN, product cases shall have applicable NSN annotated on case and inner packages labels. � All pallets are to have the identical TyHi stack pattern except for the final pallet.� � All product to be delivered on standard 48"" by 40"" pallet, not to exceed 60� in height, stretch wrapped and secured to pallet for safe transport. ------------------------------------------------------------------------------------------------------------------ �
 

Web Link

SAM.gov Permalink
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Record

SN05978077-F 20210422/210420230123 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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