Identity
- Trade Name
- Critical Cover FDA UDI
- Generic Name
- Surgical/medical face mask, non-antimicrobial, single-use FDA UDI
- Device Name
- POSITIVE FACIAL LOCK , HEADBAND, BLUE FDA UDI
- Model / Reference
- 1008 COTT BULK FDA UDI
- Description
- POSITIVE FACIAL LOCK , HEADBAND, BLUE FDA UDI
Identifiers
- Catalog Number
- 1008 COTT BULK FDA UDI
- Primary DI / UDI-DI
- 00817583020635 FDA UDI
- 510(k) Number
- K890128 FDA UDI
- FDA Product Code
- FXX FDA UDI
- GMDN Term
- Surgical/medical face mask, non-antimicrobial, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical/medical face mask, non-antimicrobial, single-use
Critical Cover by Alphaprotech, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical/medical face mask, non-antimicrobial, single-use.
- Medicom AssureMask — AMD Medicom Inc · Class II
- BENCO — BENCO DENTAL SUPPLY CO. · Class II
- Medicom AssureMask — AMD Medicom Inc · Class II
- Criterion — HENRY SCHEIN, INC. · Class II
- PRIMED — priMED Medical Products Inc · Class II
- NOVAPLUS — O&M HALYARD, INC. · Class II
- MEDICOM SAFEMASK CLASSICS — AMD Medicom Inc · Class II
- THE SEA — Mexpo International, Inc. · Class II
Cleared under the same submission
K890128 also covers:
- Critical Cover — ALPHAPROTECH, INC.
- Critical Cover — ALPHAPROTECH, INC.
- Critical Cover — ALPHAPROTECH, INC.
- Critical Cover — ALPHAPROTECH, INC.
- Critical Cover — ALPHAPROTECH, INC.
- Critical Cover — ALPHAPROTECH, INC.
- Critical Cover — ALPHAPROTECH, INC.
- Critical Cover — ALPHAPROTECH, INC.
- Critical Cover — ALPHAPROTECH, INC.
- Critical Cover — ALPHAPROTECH, INC.
- Critical Cover — ALPHAPROTECH, INC.
- Critical Cover — ALPHAPROTECH, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Alphaprotech, Inc.
Sources (1)
- FDA UDI 3613e799-3f55-4e7c-aab3-a5818bdd6276 36 fields · synced May 30, 2026