PlastCare PG-MBK2
PlastCare PG-MBK2 is a Class II device made by Proguard Health Inc., cleared under FDA 510(k) K023755 on 10 Jun 2003 and listed in FDA GUDID since 2 Jul 2021 (UDI-DI D066PGMBK21), active as of 22 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 | NumberD066PGMBK21 | Date2 Jul 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK023755 | Date10 Jun 2003 | StatusActive |
Official records
- FDA 510(k) database K023755
Across registries
- FDA 510(k) K023755 decided 10 Jun 2003 Active
- FDA GUDID UDI-DI D066PGMBK21 listed 2 Jul 2021 Listed
Timeline
- Cleared FDA 510(k) K023755
- Listed FDA GUDID D066PGMBK21
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- PlastCare
- Generic name
- Surgical/medical respirator, non-antimicrobial, single-use
- Model / Ref / Catalog
- PG-MBK2
- Description
- Ear-Loop Mask Black (Level 2)
- Primary DI / UDI-DI
- D066PGMBK21
- 510(k) Number
- FDA product code
- FXX
- GMDN term
- Surgical/medical respirator, non-antimicrobial, single-use
- Device class
- Class II
- Regulation number
- 878.4040
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Safe
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