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NitriDerm®

FDA UDI

Class I (US FDA UDI)

by Innovative Healthcare Corporation

Identity

Trade Name
NitriDerm® FDA UDI
Generic Name
Nitrile surgical glove, non-powdered FDA UDI
Device Name
Gloves, Surgical, Nitrile, Chemo, Powder-Free, Textured, 8 FDA UDI
Model / Reference
135280 FDA UDI
Description
Gloves, Surgical, Nitrile, Chemo, Powder-Free, Textured, 8 FDA UDI

Identifiers

Primary DI / UDI-DI
20813172024224 FDA UDI
FDA Product Code
KGO FDA UDI
LZC FDA UDI
GMDN Term
Nitrile surgical glove, non-powdered FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4460 FDA UDI
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

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Nitrile surgical glove, non-powdered

NitriDerm® by Innovative Healthcare Corporation — 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
Innovative Healthcare Corporation

Sources (1)

  • FDA UDI 39d1e02f-847f-440b-8255-5cce17cf6c5e 33 fields · synced Jun 8, 2026