Shield PFL008
Shield PFL008 (PFL008-1) is a Class II device made by Certol International, LLC, cleared under FDA 510(k) K890128 on 14 Feb 1989 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI H816PFL0081), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberH816PFL0081 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK890128 | Date14 Feb 1989 | StatusActive |
Official records
- FDA 510(k) database K890128
Across registries
- FDA 510(k) K890128 decided 14 Feb 1989 Active
- FDA GUDID UDI-DI H816PFL0081 listed 23 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K890128
- Listed FDA GUDID H816PFL0081
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Shield
- Generic name
- Surgical/medical face mask, single-use
- Model / Ref / Catalog
- PFL008, PFL008-1
- Primary DI / UDI-DI
- H816PFL0081
- 510(k) Number
- FDA product code
- FXX
- GMDN term
- Surgical/medical face mask, single-use
- Device class
- Class II
- Regulation number
- 878.4040
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code FXX (Mask, Surgical).
- Livocare Surgical Mask by Andon Health Co., Ltd.
- Medical Protective Masks by Qinhuangdao Taizhi Medical Technology Co., Ltd.
- ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400G by MEDTECS (TAIWAN) CORP.
- MODIFIED STERILIZATION OF TUR APRONS by Brant-Wald Surgicals, Inc.
- Surgical Face Mask by Foshan Nanhai Plus Medical Co., Ltd
- Surgical mask by Shandong Shengquan New Materials Co., Ltd.
- Face Mask by Jinhua Jingdi Medical Supplies Co.,Ltd.
- EYSOTEK by Isotech Corp.
- Disposable Medical Face Mask by Jkh USA, LLC
- BARRIER* EXTRA PROTECTION PLUS FACE MASK by Johnson & Johnson Medical, Inc.