Disposable Surgical Face Mask
by Guangdong Bida Medical Technology Co., Ltd.
510(k) K202387
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK202387 | Date23 Apr 2021 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FXX
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4040
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a Disposable Surgical Face Mask, classified under product code FXX as a Class 2 General Hospital device. It is designed to provide barrier protection for healthcare professionals and patients during surgical procedures, reducing the risk of airborne and droplet transmission of pathogens. The mask is engineered to fit securely over the nose and mouth, ensuring a snug seal while maintaining breathability. Its construction adheres to standards for fluid resistance and filtration efficiency, critical for sterile environments.
The mask is intended for single-use only and must be discarded after each procedure to maintain sterility. Supplied in sterile packaging, it is regulated under FDA 510(k) clearance (K202387) via the Traditional pathway, ensuring compliance with U.S. medical device standards. No additional sterilization or reprocessing is required before use. Its design and materials are optimized for comfort during extended wear in operating rooms and clinical settings, with no MRI compatibility restrictions noted.