New York State Seeks Medical Protective Equipment Supplies and Manufacturers

Greater Rochester Chamber of Commerce is working with New York State to identify manufacturers that can quickly produce personal protective equipment for medical staff and those responding to the Coronavirus/COVID-19 pandemic. Governor Cuomo said New York State plans to pay a premium for this equipment. See below for links to equipment specifications.

Items needed include:

  • Medical masks
  • Face shields and goggles
  • Gloves
  • Gowns

Other equipment needed includes:

  • Ventilators
  • Hand sanitizer
  • Thermometers
  • Cold and flu medications

Click here if your organization has these items in stock or has the capability to produce any of these items.

New York State procurement form

Medical face masks specifications

Surgical gown specifications

Apparel and draping specifications

Nitrile gloves specifications

Natural rubber gloves specifications

U. S. Food and Drug Administration Guidance on Masks and Gowns

Gowns:

Surgical gowns (including surgical isolation gowns), surgical hoods, and surgical togas are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, bodily fluids, and particulate material. FDA regulates surgical gowns, surgical isolation gowns, surgical hoods and surgical togas as Class II devices and assesses them for liquid barrier protection among other things.

FDA does not object to your marketing and distribution of the gown and surgical apparel products in the healthcare setting without prior 510(k) clearance if the product is labeled in the following manner:

1) The apparel is not labeled as "surgical”; rather it may be labeled as a “gown”, “toga”, “hood”, etc.

2) It states it may be used when FDA cleared gowns or apparel are unavailable

3) Includes a recommendation against use in a surgical setting or where significant exposure to liquid bodily or other hazardous fluids may be expected;

4) Includes a recommendation against use in a clinical setting where the infection risk level is high;

5) It makes no claims regarding flammability;

6) It makes no claims of antimicrobial or antiviral protection;

7) It makes no claims of infection prevention or reduction;

8) Contains a list of the body contacting materials.

In addition, FDA does not intend to object to marketing of gowns and other surgical apparel that meet the above criteria even if they are manufactured at facilities that do not meet 21 CFR 820.


Masks:

Surgical masks provide protection against large droplets, splashes or sprays of bodily or hazardous fluids. They do not provide the wearer with reliable protection from inhaling smaller airborne particles and are not considered respiratory protection. FDA regulates surgical masks as Class II devices and assesses them for liquid barrier protection among other things.

FDA recognizes the urgent need for face masks in the setting of the COVID-19 pandemic due to increased use and shortages in their availability.

FDA does not object to the marketing and distribution of face masks in the healthcare setting without prior 510(k) clearance if the product is labeled in the following manner:

1) It states it may be used when FDA cleared masks are unavailable;

2) It recommends against use in a surgical setting or where significant exposure to liquid bodily or other hazardous fluids may be expected;

3) It makes no claims of antimicrobial or antiviral protection;

4) It makes no claims of infection prevention or reduction;

5) It makes no claims regarding flammability

6) The labeling contains a list of the body contacting materials.

7) The mask is not labeled as a "surgical mask”; rather it may be labeled as a “face mask”


In addition, FDA does not intend to object to marketing of masks that meet the above criteria even if they are manufactured at facilities that do not meet 21 CFR 820.