Halyard 99175
Halyard 99175 is a Class II device made by O&M Halyard Inc., cleared under FDA 510(k) K974068 on 22 Dec 1997 and listed in FDA GUDID since 14 Aug 2020 (UDI-DI 30680651991752), active as of 23 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number30680651991752 | Date14 Aug 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK974068 | Date22 Dec 1997 | StatusActive |
Official records
- AccessGUDID record 30680651991752
- FDA 510(k) database K974068
Across registries
- FDA 510(k) K974068 decided 22 Dec 1997 Active
- FDA GUDID UDI-DI 30680651991752 listed 14 Aug 2020 Listed
Recalls
-
- Ongoing Z-2626-2023
One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user.
Timeline
- Cleared FDA 510(k) K974068
- Listed FDA GUDID 30680651991752
- Recall initiated FDA recalls Z-2626-2023
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Halyard
- Generic name
- Surgical/medical face mask, non-antimicrobial, single-use
- Model / Ref / Catalog
- 99175
- Primary DI / UDI-DI
- 30680651991752
- 510(k) Number
- FDA product code
- MSH
- GMDN term
- Surgical/medical face mask, non-antimicrobial, single-use
- Device class
- Class II
- Regulation number
- 878.4040
- GUDID distribution status
- In Commercial Distribution
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