Certificate

Standards for Gowns

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.

The performance of gowns is tested using consensus standards:

American Society for Testing and Materials (ASTM) F2407 is an umbrella document which describes testing for surgical gowns: tear resistance, seam strength, lint generation, evaporative resistance, and water vapor transmission

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.

Below is a table summarizing the ANSI/AAMI PB70 standard recognized by the FDA.

Level - 1

Sub headings : Level 1
Description :

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.
Applicability : Basic Care, Standard Hospital Medical Unit

Level - 2

Sub headings : Level 2
Description :

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: 1 - Water impacting the surface of the gown material, 2 - Pressurizing the material
Applicability : Blood draw from a vein - Suturing - Intensive care unit - Pathology lab

Level - 3

Sub headings : Level 3
Description :

Used in Moderate risk situations
Provides a barrier to larger amounts of fluid penetration through splatter and more fluid exposure through soaking than Level 2
Two tests are conducted to assess barrier protection performance: 1 - Water impacting the surface of the gown material, 2 - Pressurizing the material
Applicability : Arterial Blood Draw - Inserting an IV - Emergency Room - Trauma

Level - 4

Sub headings : Level 4
Description :

Used in High risk situations
Prevents all fluid penetration for up to 1 hour
May prevent VIRUS penetration for up to 1 hour
In addition to the other tests conducted under levels 1-3, barrier level performance is tested with a simulated blood containing a virus. If no virus is found at the end of the test, the gown passes
Applicability : Pathogen Resistance - Infectious Diseases ( non-airborne ) - Large Amounts of Fluid Exposure Over Long Periods

Conformance with recognized consensus standards is voluntary for a medical device manufacturer. A manufacturer may choose to conform to applicable recognized standards or may choose to address relevant issues in another manner.

Link : https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/medical-gowns