Nitrile exam glove Sources Sought 11-3-26.docx

In accordance with Section 1 of Executive Order (E.O.) 14005, Ensuring the Future Is Made in All of America by All of America’s Workers, the Department of War (DoW) is conducting market research regarding the availability of domestically manufactured nitrile examination gloves to meet clinical demand by military treatment facility customers. The Government seeks to understand industry capability to establish, validate, expand, and sustain U.S.-based production capacity sufficient to meet projected demand while conforming to applicable product-quality, regulatory, safety, labor, supply-chain, and contract requirements. The Government is particularly interested in manufacturers with existing U.S. production, U.S.-based facilities capable of conversion or expansion, or credible plans to initiate U.S. production within a ramp-up period.

Product Requirements:

Vendors responding to this RFI must be capable of providing a nitrile exam glove that meets ALL of the below minimum requirements:

1. Be a domestic end-product in alignment with Section 1 of Executive Order (E.O.) 14005, Ensuring the Future is Made in All of America by All of America's Workers.

2. Meet or exceed relevant American Society for Testing and Materials (ASTM) and International Organization for Standardization (ISO) standards shown below:

· ASTM D412: Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers

· ASTM D5151: Standard Test Method for Detection of Holes in Medical Gloves

· ASTM D6319: Standard Specification for Nitrile Examination Gloves for Medical Application

· ASTM D6124: Standard Test Method for Residual Powder on Medical Gloves

· ASTM D6978: Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs

· ASTM F1671: Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System

· ISO 10993: Biological Evaluation of Medical Devices

3. Provide balanced durability tensile strength (ASTM D412), and tactile sensitivity (ASTM D3767) sufficient for sustained use in high‑volume medical environments without tearing, excessive fatigue, or compromised performance.

5. Demonstrate resistance to chemotherapy and other hazardous drugs. Testing shall have been performed against a broad panel of drugs, totaling not fewer than 50 drugs, to ensure suitability for oncology and hazardous drug handling (ASTM 6978). The drugs tested must come from the ASTM 6978 standard and/or the National Institute for Occupational Safety and Health (NIOSH) List of Hazardous Drugs in Health Care Settings found here,https://www.cdc.gov/niosh/publications/hcp/numbered/2025-103.html

6. Provide proven barrier protection against fentanyl and gastric acid permeability, ensuring safety in emergency, laboratory, and field clinical scenarios involving exposure to potent synthetic opioids and corrosive substances (ASTM D5151 and ASTM F1671).

· Successful permeation testing for both fentanyl citrate and simulated gastric acid is required.

7. Have an FDA cleared labeling claim for low dermatitis potential (supported by clinical data and ISO 10993).

8. Maintain an Acceptable Quality Level (AQL) of 1.0 or better, exceeding typical industry thresholds to ensure superior defect control and reliable barrier reliability in diverse medical settings (ASTM D5151).

8. Possess FDA Class I reserved medical device status with active 510(k) clearance demonstrating equivalency and compliance with federal performance and safety requirements.

9. Nitrile Exam Gloves shall not be black in color for medical treatment facility use. Acceptable glove colors include, but are not limited to, grey blue, and lavender.

· Lighter glove colors are preferred as they provide greater visual contrast with blood and body fluids. Documentation shall confirm either:

i. The glove color was cleared in the 510(k); or

ii. The color change did not require a new 510(k) because it was tested and did not constitute a material change.

Technical & Regulatory Requirements All products must be FDA-compliant medical nitrile exam gloves that meet the above requirements at the time of response. Respondents should identify any additional certifications applicable to their manufacturing facility (ISO, quality management certifications, etc.) and provide their current FDA 510(k) clearance.

Purpose of This RFI This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Responses do not commit the U.S. Government to issuing a solicitation, making an award, or paying any response costs. All information submitted remains the property of the U.S. Government and will not be returned.

Submission Instructions Interested parties shall submit responses electronically via email to Catherine Gilbert (catherine.gilbert@dla.mil) and Jayne Do (jayne.do@dla.mil) in PDF or Microsoft Word format. Responses should be concise and limited to information relevant to the requirements identified in this notice.

Requested Information from Respondents Interested vendors should provide the information below via Attachment 1 to this RFI along with any supporting documentation provided as separate attachments to your company’s submission:

· Company name, business size, address, and point of contact.

· Identify how the nitrile exam glove meets the above minimum requirements and provide supporting evidence to establish the offered product complies with each clinical requirement.

· If domestic manufacturing does not exist, identify a specific manufacturing facility location that can establish the required domestic manufacturing for nitrile exam gloves and identify the timeframe for commencing domestic manufacturing providing specific approvals and contingencies, if applicable.

· If the respondent has partnered with a US-Manufacturer to produce a nitrile exam glove meeting the minimum requirements stated above, provide the partner’s name, address, point of contact, and indicate whether a signed letter of commitment is in place.

· Identify the Country of origin for the Nitrile Butadiene Rubber (NBR)

· Identify manufacturing capacity and lead times of the respondent or its partner.

· Explain how the glove is dispensed from the box. Does the box allow for a single-glove withdrawal, prevent multiple gloves from dispensing at once, or any other means of minimizing cross contamination? Explain if/how the box minimizes cross contamination by controlling dispensing and reducing waste. The dispensing method should support established infection‑control best practices.

· Any additional relevant product or capability information.