Since years, many names have been worn to introduce gowns designed for the use in medical ambience that includes, not limiting its extent to, surgical gowns, non-surgical gowns, surgical-isolation gowns, operating-room gown and procedural gown; in accordance to a freshly liberated Draft Guidance Document from the FDA.
FDA now seeks to analyze the guidelines that help in determining if any type of gown should be allocated as Class II medical accessory that may require premarket bulletin. The blueprint has proposed that any apparel which claims to offer ANSI/AAMI/PB 70 Level 3 or 4 safeties corresponding to mild or powerful barrier protection is acknowledged Class II medical device which determines the fluid barrier achievement as defined in PB70 standards. Further, if any gown classified as surgical gown or the one expected for such use in the course of sterile processes, will fall in the same category.
Following are the major guidelines as specified in the draft which needs to be submitted as a part of 510(k) application for Class II gowns:
1. "Evidence that the gown complies with the claimed barrier performance criteria of the currently FDA-recognized version of ANSI/AAMI PB70 or equivalent standard. ANSI/AAMI PB70 establishes physical performance and documentation requirements for gowns and their materials.
2. Performance test data to demonstrate that the gown is an effective barrier in accordance with ANSI/AAMI PB70 barrier performance specifications. Barrier performance testing should be completed on the final, finished, pre-shipment gown, or at the end of the stated shelf life of the gown, as applicable, if the gown is reusable.
3. Representative engineering drawing(s), schematics, illustrations and/or figures of the gown that are clear, legible, labeled with the barrier protection levels of the gown, and include dimensions and the location of the critical and non-critical zones.
4. Sample labeling that clearly identifies the level of liquid barrier protection per ANSI/AAMI PB70.
5. Sample labeling that includes the direction(s) for use and indication (s) for use."
Class I gowns, which are “labeled as a gown other than a surgical gown (e.g., isolation gown)” or “are for only minimal or low barrier protection,” described as PB70 Level 1 or 2, are exempt from the premarket notification requirement. These types of gowns must still comply with general controls including the quality system regulation (21 CFR part 820), registration and listing (21 CFR 207 part 807), medical device reporting (21 CFR part 803), and labeling (21 CFR part 801), among others.