Product Compliance

Having accessible and accurate facts is important when it comes to personal protective equipment. We are here to simplify industry jargon that often misleads the public with inconsistent or incomplete information. Masks Guru is committed to providing our healthcare workers, and their loved ones, with the peace of mind and confidence in our products while making a well-informed decision to protect yourself in the workplace.

Types of Gowns

Non-Surgical Gowns

Non-surgical gowns are Class I devices (exempt from premarket review) intended to protect the wearer from the transfer of microorganisms and body fluids in low or minimal risk patient isolation situations. Non-surgical gowns are not worn during surgical procedures, invasive procedures, or when there is a medium to high risk of contamination.

Surgical Isolation Gowns

Surgical isolation gowns are used when there is a medium to high risk of contamination and a need for larger critical zones than traditional surgical gowns. Surgical isolation gowns, like surgical gowns, are regulated by the FDA as a Class II medical device that requires a 510(k) premarket notification.

Surgical Gowns

A surgical gown is regulated by the FDA as a Class II medical device that requires a 510(k) premarket notification. A surgical gown is a personal protective garment intended to be worn by health care personnel during surgical procedures to protect both the patient and health care personnel from the transfer of microorganisms, body fluids, and particulate matter.

AAMI Gowns Standards

Labeling that shows a product has been tested to and meets appropriate performance standards is one way for users and procurers to determine when to use a particular gown.

American Society for Testing and Materials (ASTM) F2407 is an umbrella document which describes testing for surgical gowns. Below is a summary of ASTM F2407 standard recognized by the FDA.

  • Tensile Strength: ASTM D5034, ASTM D1682

  • Tear resistance: ASTM D5587 (woven), ASTM D5587 (nonwoven), ASTM D1424

  • Seam Strength: ASTM D751 (stretch woven or knit)

  • Lint Generation: (ISO 9073 Part 10)

  • Water vapor transmission: (breathability) ASTM F1868 Part B, ASTM D6701 (nonwoven), ASTM D737-75

American National Standards Institute (ANSI) and the Association of the Advancement of Medical Instrumentation (AAMI): ANSI/AAMI PB70:2003 describes liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities.

ANSI/AAMI PB70 Standard Recognized by the FDA

LEVEL 1

Minimal Risk

 

Provides a slight barrier to small amounts of fluid penetration.

General hospital use and basic care.

  • Tested for water resistance.

LEVEL 2

Low Risk

 

Provides a barrier to larger amounts of fluid penetration through splatter and soaking.

Blood draws, work in pathology labs.

  • Tested for water resistance.

  • Tested for water pressure.

LEVEL 3

Moderate Risk

 

Provides barrier to larger amounts of fluid penetration through splatter and soaking.  More than level 2.

Arterial blood draws, IV insertions, emergency rooms and trauma.

  • Tested for water resistance.

  • Tested for water pressure.

LEVEL 4

High Risk

 

Pathogen resistance, infection, non-airborne diseases, large amounts of fluid exposure over long periods of time.

Prevents all fluid penetration for up to 1 hour.

May prevent virus penetration for up to 1 hour.

  • Tested for water resistance.

  • Tested for water pressure.

  • Tested for blood penetration.

  • Tested for viral penetration.

Critical Zones

An AAMI rated gown’s rating comes from the liquid barrier protection of its critical zones, where the wearer is most likely to come into contact with fluid and contaminants. Critical zones are determined by a gown’s purpose and must meet or surpass AAMI requirements for the gown to be properly rated.

Critical Zones for Non-Surgical and Isolation Gowns

  • The entire gown (areas A, B, and C), including seams but excluding cuff, hems, and bindings, is required to have a barrier performance of at least Level 1.

Critical Zones for Surgical Gowns

  • The entire front of the gown (areas A, B, and C) is required to have a barrier performance of at least level 1

  • The critical zone compromises at least areas A and B.

  • The back of the surgical gown (area D) may be nonprotective.

SOCIAL

  • Facebook
  • Twitter
  • Instagram

© 2021 MasksGuru  |  All Rights Reserves  |  Created by LA Web Design