Shieldmate

FDA UDI

Class II (US FDA UDI)

by Alphaprotech, Inc.

Identity

Trade Name: SHIELDMATE FDA UDI
Generic Name: Eye splash shield, single-use FDA UDI
Device Name: EARLOOP MASK, W/SHIELD & MAGIC ARCH, ANTIFOG FOAM STRIP, BLUE FDA UDI
Model / Reference: SHIBL6155S FDA UDI
Description: EARLOOP MASK, W/SHIELD & MAGIC ARCH, ANTIFOG FOAM STRIP, BLUE FDA UDI

Identifiers

Catalog Number: SHIBL6155S FDA UDI
Primary DI / UDI-DI: 10817583020526 FDA UDI
510(k) Number: K882028 FDA UDI
FDA Product Code: FXX FDA UDI
GMDN Term: Eye splash shield, 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

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

Shieldmate by Alphaprotech, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K882028 also covers:

SHIELDMATE — 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 1294c394-1a04-46fd-ad2f-c79b62bbf594 36 fields · synced May 30, 2026