Premarket Regulatory Requirements for Liquid Barrier Protection Claims in Medical Gowns
This guidance focuses on gowns making liquid barrier protection claims intended for use in healthcare settings. It specifically addresses gowns with minimal/low barrier protection (ANSI/AAMI PB70 Level 1-2) and moderate/high barrier protection (ANSI/AAMI PB70 Level 3-4). The guidance excludes gowns making claims about protection against specific organisms, chemical agents, chemotherapy drugs, or specific disease prevention claims.
Recommended Actions
- Determine gown classification based on intended use and barrier protection claims
- For Class II gowns (surgical gowns), prepare and submit 510(k) including:
- Barrier performance test data according to ANSI/AAMI PB70
- Engineering drawings with required details
- Compliant labeling
- Directions for use
- For gowns marketed before June 26, 2015 without 510(k) clearance:
- Submit 510(k) within 60 days of guidance publication
- Obtain acceptance for review within 75 days
- Obtain clearance within 180 days
- Consider bundling multiple gowns in a single 510(k) submission if applicable
- Ensure quality system compliance for both Class I and Class II gowns
Key Considerations
Non-clinical testing
- Barrier performance testing must comply with claimed barrier performance criteria of FDA-recognized ANSI/AAMI PB70 or equivalent standard
- Testing must be performed on final, finished, pre-shipment gown at the end of stated shelf life
- For reusable gowns, additional testing required at end of labeled use-life (maximum reprocessing cycles)
Labelling
- Must clearly identify level of liquid barrier protection per ANSI/AAMI PB70
- Must include directions for use and indications for use
- Terminology used in labeling impacts device classification (Class I vs Class II)
Other considerations
- Engineering drawings/schematics must be clear, legible, labeled with barrier protection levels
- Drawings must include dimensions and location of critical/non-critical zones
Relevant Guidances
- Surgical Gowns and Surgical Drapes - Performance Testing and Labeling Requirements
- Refuse to Accept Policy for 510k Submissions: Minimum Threshold Requirements for Administrative and Technical Review
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
Related references and norms
- ANSI/AAMI PB70: Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
Original guidance
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