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Protect 800

FDA UDI

Class I (US FDA UDI)

by McGowan Enterprises, Inc.

Identity

Trade Name
PROTECT 800 FDA UDI
Generic Name
Nitrile surgical glove, non-powdered FDA UDI
Device Name
SURGICAL GLOVE, STERILE, NITRILE, 12" LENGTH, CHEMO TESTED, POWDER FREE, WHITE, MEDIUM FDA UDI
Model / Reference
PROSNCG-M FDA UDI
Description
SURGICAL GLOVE, STERILE, NITRILE, 12" LENGTH, CHEMO TESTED, POWDER FREE, WHITE, MEDIUM FDA UDI

Identifiers

Catalog Number
PROSNCG-M FDA UDI
Primary DI / UDI-DI
00075289715211 FDA UDI
FDA Product Code
OPJ FDA UDI
GMDN Term
Nitrile surgical glove, non-powdered FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6250 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI

Category: Nitrile surgical glove, non-powdered

Protect 800 by McGowan Enterprises, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Nitrile surgical glove, non-powdered.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
McGowan Enterprises, Inc.

Sources (1)

  • FDA UDI 2a91be02-66be-47bd-ab39-54e0da50e9b9 35 fields · synced May 30, 2026