The U.S. Food and Drug Administration (FDA) held a webinar on January 21, 2016. The guidance document described the regulatory requirements for non woven surgical gowns and the required performance tests. According to Article 21 of Article 878.4040 of the Code of Federal Regulations (CFR), the FDA stipulates that surgical gowns and surgical face masks are classified as Class II medical devices, subject to pre-market review. In addition, the FDA recognized the PB70:2003 standard jointly developed by the American National Standards Institute and the Association of the Advancement of Medical Instrumentation (ANSI/AAMI), and passed the designated verification and verification of the new standard. The defined barrier protection level requires test methods and performance results to evaluate the barrier protection level.

For surgical gowns subject to pre-market notification under Article 21cfr 878.4040(b)(1) of the Federal Regulations, the manufacturer must include the following in its 510(k) submission:

1. Prove that the surgical gown meets the ANSI/AAMI PB70 or equivalent barrier performance standards recognized by the US Food and Drug Administration. ANSI/AAMI PB70 specifies the physical properties and documentation requirements of surgical gowns and their materials;

2. Performance test data to prove that the surgical gown is an effective barrier and meets ANSI/AAMI PB70 barrier performance specifications;

3. Representative engineering drawings, schematic diagrams, diagrams or clear and easy-to-read surgical gown numbers, and note Specify the barrier protection level of the surgical gown, including the size and location of the critical and non-critical areas;

4. According to ANSI/AAMI PB70, a sample label that clearly identifies the level of protection of the liquid barrier;

5. Sample label including instructions for use and instructions for use.