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What's PPE Materials?

Mask material information below from Mask for Heroes who says "This is a list of some of the most preferred materials for fabric masks we have seen from hospitals, articles, and research. For those making a cotton mask with a filter pocket, this is also a list of some of the filter materials that can be added.
Tag you friends so they know what to use.
As a reminder fabric masks should be replaced often, washed after each use, and you should remember not to touch them while wearing. If so, wash your hands. And STAY HOME unless you are an essential worker or leaving for essential purposes."

 

 

 

The information below was provided by Fashion for the Frontlines. 

Material Specs:

Medical Gown Material: 

  • High-density polyethylene (HDPE) and polypropylene (PP) are used as raw materials, and polyethylene coating on polypropylene (PP) has excellent anti-static performance, which is permanent and can effectively release human electrostatic charges.
  • PE composite nonwovens are dust-free, non-sticky, good barrier, high density, high strength, effective sterilization and bacteriostasis, providing effective protection for wearers.
  • PE laminated non-woven fabric and other composite non woven fabric is widely used because of their waterproof, sun-proof and dust-proof properties, as well as a hydrophilic, anti-static and anti-aging treatment. They are mostly used for medical and hygiene, personal care, and industrial field, mainly used to produce surgical gown, surgical bag, isolation gown, protective clothing

Our legal team has just notified us that the FDA has just (this AM) waived requirements for certification, so long as the product supports the L3 fabric standards.. 

We should convey to the hospitals that FDA has relaxed the requirements but that we will comply with all labeling recommendations and that the products meet the ASTM standards for Level 3 gowns.

A quick read of FDA’s guidance shows that they treat “non-surgical gowns” and “surgical gowns” differently, but bottom line is that FDA is waiving/exempting requirements for both.

Here are the two summaries of most important aspect:

Non-Surgical Gowns:

To help foster the availability of these types of gowns and apparel during the COVID-19 public health emergency, FDA does not intend to object to the distribution and use of gowns not intended for use as “surgical gowns” and other low-to-minimal barrier protection surgical apparel that does not comply with the following regulatory requirements where the gowns and apparel do not create an undue risk in light of the public health emergency: Registration and Listing requirements in 21 CFR 807, Quality System Regulation requirements in 21 CFR 820, reports of corrections and removals in 21 CFR Part 806, and Unique Device Identification requirements in 21 CFR Part 830 and 21 CFR Part 801.20. FDA currently believes such devices would not create such an undue risk where:

  • The product includes labeling that accurately describes the product as a “gown,” or “toga,” or other apparel (as opposed to a “surgical gown,” or “surgical toga”) and includes a list of the body contacting materials (which does not include any drugs or biologics);
  • The product includes labeling that makes recommendations that would reduce sufficiently the risk of use, for example, recommendations against: use in a surgical setting or where significant exposure to liquid bodily or other hazardous fluids may be expected, use in a clinical setting where Level 3 or 4 protection is warranted, and use in the presence of high intensity heat source or flammable gas; and
  • The product is not intended for any use that would create an undue risk in light of the public health emergency, for example, the labeling does not include uses for antimicrobial or antiviral protection or related uses or uses for infection prevention or reduction or related uses.

Surgical Gowns

FDA recognizes the urgent need during the COVID-19 public health emergency for moderate-to-high barrier protection surgical gowns due to increased use and demand which has led to shortages in their availability. To ensure the availability of these types of surgical gowns during the COVID-19 public health emergency, FDA does not intend to object to the distribution and use of ANSI/AAMI PB70 Level 3 moderate-to-high barrier protection surgical gowns that do not comply with the following regulatory requirements, where such surgical gowns do not create an undue risk in light of the public health emergency: Prior submission of a premarket notification under section 510(k) of the FD&C Act and 21 CFR 807.81,20 Registration and Listing requirements in 21 CFR 807, and Unique Device Identification requirements in 21 CFR Part 830 and 21 CFR 801.20. FDA currently believes such devices would not create such an undue risk where:

  • The product:
  • Meets liquid barrier protection at Level 3 or higher, consistent with ANSI/AAMI PB70 for the critical zone areas;
  • Meets the Class I or Class II flammability standard per 16 CFR Part 1610; and
  • Has been demonstrated to be sterile if intended for use in surgical settings.
  • The product includes labeling that accurately describes the product’s sterility status (sterile or non-sterile), including any sterilization method used, barrier protection as Level 3, flammability classification (Class I or Class II), and a list of the body contacting materials;
  • The product includes labeling with general statements and makes recommendations that would sufficiently reduce the risk of use, for example, a general statement about devices that have not been cleared by FDA, recommendations against use when FDA-cleared surgical gowns are available, and recommendations against use of non-sterile products in surgical settings; and
  • The product is not intended for any use that would create an undue risk in light of the public health emergency, for example, the labeling does not include uses for antimicrobial or antiviral protection; uses for infection prevention or reduction; or is labeled as having ANSI/AAMI PB70 Level 4 liquid barrier protection