Critical Cover

FDA UDI

Class I (US FDA UDI)

by Alphaprotech, Inc.

Identity

Trade Name: Critical Cover FDA UDI
Generic Name: Eye splash shield, single-use FDA UDI
Device Name: Full Face Shield, anti-fog, foam strip, attached comfort headband with snaps FDA UDI
Model / Reference: 1807 FDA UDI
Description: Full Face Shield, anti-fog, foam strip, attached comfort headband with snaps FDA UDI

Identifiers

Catalog Number: 1807 FDA UDI
Primary DI / UDI-DI: 10817583023312 FDA UDI
510(k) Number: K875302 FDA UDI
FDA Product Code: HOY FDA UDI
GMDN Term: Eye splash shield, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 886.4750 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Eye splash shield, single-use

Critical Cover by Alphaprotech, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K875302 also covers:

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 I	Pending data

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Manufacturer

Manufacturer: Alphaprotech, Inc.

Sources (1)

FDA UDI b35fecb8-2e97-4c3e-80b3-512128d3dbff 36 fields · synced Jun 6, 2026