Identity
- Trade Name
- NOVAPLUS FDA UDI
- Generic Name
- Polyisoprene surgical glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- NOVAPLUS® GAMMEX® Non-Latex PI Size 7, Sterile Polyisoprene Powder-Free Surgical Glove FDA UDI
- Model / Reference
- V20685770 FDA UDI
- Description
- NOVAPLUS® GAMMEX® Non-Latex PI Size 7, Sterile Polyisoprene Powder-Free Surgical Glove FDA UDI
Identifiers
- Catalog Number
- V20685770 FDA UDI
- Primary DI / UDI-DI
- 10014566300709 FDA UDI
- FDA Product Code
- KGO 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
- 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.
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- Gammex — Bosma Enterprises · Class I
- Sempermed Syntegra IR Polyisoprene Surgical Glove — SEMPERMED USA, INC.
- MEDLINE — MEDLINE INDUSTRIES, INC. · Class I
- Biogel® PI OrthoPro — Mölnlycke Health Care AB · Class I
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
- Ansell Healthcare Product
Sources (1)
- FDA UDI 499db9f7-d819-4eca-ae5e-b1e6f82d883e 36 fields · synced May 31, 2026