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Novaplus

FDA UDI

Class I (US FDA UDI)

by Ansell Healthcare Product

Identity

Trade Name
NOVAPLUS FDA UDI
Generic Name
Polyisoprene surgical glove, non-powdered, non-antimicrobial FDA UDI
Device Name
NOVAPLUS® GAMMEX® Non-Latex PI Green Size 8.5, Sterile Polyisoprene Powder-Free Surgical Glove FDA UDI
Model / Reference
V20685285 FDA UDI
Description
NOVAPLUS® GAMMEX® Non-Latex PI Green Size 8.5, Sterile Polyisoprene Powder-Free Surgical Glove FDA UDI

Identifiers

Catalog Number
V20685285 FDA UDI
Primary DI / UDI-DI
10014566400850 FDA UDI
FDA Product Code
KGO FDA UDI
LZC FDA UDI
GMDN Term
Polyisoprene surgical glove, non-powdered, non-antimicrobial 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

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

Category: Polyisoprene surgical glove, non-powdered, non-antimicrobial

Novaplus by Ansell Healthcare Product — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polyisoprene surgical glove, non-powdered, non-antimicrobial.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ansell Healthcare Product

Sources (1)

  • FDA UDI 42b9175c-448c-4cad-8012-3adda248a210 36 fields · synced Jun 1, 2026