August 21, 2020
US FDA Relaxes Regulatory Requirements for Surgical Gowns and Gloves

Amidst the Covid-19 pandemic, the demand for surgical apparel (including gowns, gloves, togas and other apparel) has increased drastically. But on the other side, supply chains are going down with minimal production. Therefore, to increase the availability of these products in need, the United States Food and Drugs Administration (US FDA) has released a guidance document addressing urgent public health concerns. The guidance is intended to remain in effect only during the public health emergency of Covid-19. It is applicable to the following product categories of surgical apparels and gloves:

Classification Regulation

Device Type

Class

21 CFR 878.4040

Conductive Shoe and Shoe Cover

I (Exempt)

21 CFR 878.4040

u

Operating Room Shoes

I (Exempt)

21 CFR 878.4040

Surgical Apparel Accessory

I (Exempt)

21 CFR 878.4040

Non-surgical Isolation Gowns

I (Exempt)

21 CFR 878.4040

Surgical Suits

I (Exempt)

21 CFR 878.4040

Operating Room Shoe Covers

I (Exempt)

21 CFR 878.4040

Surgical Helmets

I (Exempt)

21 CFR 878.4040

Surgical Dress

I (Exempt)

21 CFR 878.4040

Surgical Caps

I (Exempt)

21 CFR 878.4040

Surgical Gown/Toga

II

21 CFR 878.4040

Patient Gown

II

21 CFR 878.4040

Surgical Isolation Gown

II

21 CFR 878.4040

Surgical Hood

II

 

Classification Regulation

Device Type

Class

21 CFR 880.6250

Patient Examination Glove

I (Reserved)

21 CFR 880.6250

Latex Patient Examination Glove

I (Reserved)

21 CFR 880.6250

Polymer Patient Examination Glove

I (Reserved)

21 CFR 880.6250

Finger Cot

I (Reserved)

21 CFR 880.6250

Vinyl Patient Examination Glove

I (Reserved)

21 CFR 880.6250

Powder-free Guayle Rubber Examination Glove

I (Reserved)

21 CFR 880.6250

Powder-free Polychlorophene Patient Examination Glove

I (Reserved)

21 CFR 880.6250

Radiation Attenuating Medical Glove

I (Reserved)

21 CFR 880.6250

Special Patient Examination Glove

I (Reserved)

21 CFR 880.4460

Surgeon’s Glove

I (Reserved)

21 CFR 880.4460

Powder-free Non-natural Rubber Latex Surgeon’s Gloves

I (Reserved)

Source: FDA

According to the guidance, to meet the increasing demand for the surgical apparel and gloves, the FDA does not intend to object the distribution and use of these products as long as they do not pose any undue risk to the safety of the general public and healthcare professionals. However, they must meet certain manufacturing criteria to be deemed as safe for use. Here are a few key insights.

Surgical Gowns and Apparels

The FDA guidance defines Regulatory requirements for surgical gowns and other minimal- to low-barrier protection surgical apparels, which do not fall under the category of pre-market authorization. The guidance is also applicable to non-surgical gowns which are intended to protect the user from micro-organisms and bodily fluids under low- to minimal-risk patient isolation but are not used for surgical purposes.

For Class II category surgical gowns that are subject to pre-market authorization, the FDA is going to allow distribution and use of ANSI/AAMI PB70 Level 3 moderate- to high-barrier protection surgical gowns which do not comply with certain Regulatory requirements of the FDA. In addition to this, the surgical gowns must also meet the following specific criteria:

  1. If they have liquid barrier protection at Level 3 or higher
  2. If they are consistent with ANSI/AAMI PB70 for the critical zone areas
  3. If they meet the flammability standards for Class I or Class II category
  4. If they have demonstrated to be sterile for surgical use
  5. If they are labeled accurately, i.e., if they include information about sterility, sterilization method, barrier protection as Level 3, flammability classification and list of body-contacting materials

Surgical Gloves

The FDA guidance suggests that the package label of surgical gloves to mention the product is not approved by the FDA and its usage must be stopped once FDA-approved gloves are available. The distribution of surgical gloves is allowed by the FDA as long as they do not pose any undue risk to the users.

The actions taken by the FDA are really important in the time of this pandemic. These are to ensure that healthcare professionals and the general public are safe from the disease, as much as possible. While the FDA has taken to ensure public safety, it is advised to the manufacturers to comply with the regulations and reach the target market compliantly. Stay safe. Stay compliant.

Category: