NYS Looking for Manufacturers to Help Produce Needed Medical Supplies

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3/24/20 UPDATE

NYS Looking for Manufacturers to Help Produce Needed Medical Supplies

The Buffalo Niagara Partnership is working to help New York State identify regional manufacturers that can quickly produce needed personal protective equipment and other medical supplies that are in short supply throughout the state.

There is an immediate need for:

  • Medical masks
  • Face shields and goggles
  • Gloves
  • Gowns
  • Ventilators
  • Hand sanitizer
  • Thermometers
  • Cold and flu medications

Below, please find relevant FDA regulatory information and manufacturing standards for surgical masks, isolation gowns, and medical gloves. The latest official manufacturing guidance documents for each manufacturing standard are linked as PDFs

Surgical Masks (not N95 respirators)
  • Regulated by FDA: FDA21 CFR 878.4040 (covers all surgical and isolation apparel)
  • Manufacturing standard:
    • ASTM F2100 – 19
    • ASTM F2100 Level 1 standards for material quality apply in hospital/ICU settings
        • Fluid Resistance with synthetic blood: 80mmHg
        • Differential pressure: <4.0mmH2O
        • Bacterial Filtration Efficiency (BFE) %: ≥95%
        • Submicron Particle Filtration (PFE) @ 0.1u, %: ≥95%
        • Flammability: Class 1 
Surgical Gowns
  • Regulated by FDA: FDA21 CFR 878.4040 (covers all surgical and isolation apparel)
  • Manufacturing standard:
    • ANSI/AAMI PB70
    • ASTM F2407
    • Gowns should adhere to ANSI/AAMI PB70 Level 1 standard in non-ICU settings, and Level 2 standard in ICU settings
      • Level 1 for use in non-ICU hospital settings:
        • Used for MINIMAL risk situations
        • Provides a slight barrier to small amounts of fluid penetration
        • Single test of water impacting the surface of the gown material is conducted to assess barrier protection performance.
      • Level 2 for use in ICU settings:
        • Used in LOW risk situations
        • Provides a barrier to larger amounts of fluid penetration through splatter and some fluid exposure through soaking
        • Two tests are conducted to assess barrier protection performance:
        • Water impacting the surface of the gown material
        • Pressurizing the material
Latex Gloves
  • Regulated by FDA: FDA21 CFR 880.6250 (non-powdered patient examination glove)
  • Manufacturing standard:
    • ASTM D6319 for powder-free nitrile gloves, ASTM D3578 for powder-free latex gloves
    • Nitrile gloves are stronger and less allergenic. Latex gloves are slightly cheaper and more biodegradable, but many people have allergies
    • ASTM D6319
Nitrile Gloves

 

If you think your facility can help produce these items or has supply in stock, please contact Empire State Development for more details:  COVID19supplies@esd.ny.gov

Thank you for your help and consideration.

We will continue to follow up as more information becomes available.  Given the fluidity of this situation, please feel free to reach out to us with questions at connect@thepartnership.org and even more importantly, if you are will to share best practices.