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 6.5, Sterile Polyisoprene Powder-Free Surgical Glove FDA UDI
- Model / Reference
- V20685765 FDA UDI
- Description
- NOVAPLUS® GAMMEX® Non-Latex PI Size 6.5, Sterile Polyisoprene Powder-Free Surgical Glove FDA UDI
Identifiers
- Catalog Number
- V20685765 FDA UDI
- Primary DI / UDI-DI
- 10014566300655 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
The NOVAPLUS medical device is a sterile, non-latex polyisoprene surgical glove designed to protect healthcare providers at the surgical site. It is made of polyisoprene and features a single-use design with appropriate characteristics for sterility, tactility, and comfort.
Similar devices
Also classified as Polyisoprene surgical glove, non-powdered, non-antimicrobial.
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- Biogel® PI Micro Indicator® Underglove — Mölnlycke Health Care AB · Class I
- Sempermed Syntegra UV Polyisoprene Surgical Glove — SEMPERMED USA, INC.
- Sempermed Syntegra IR Polyisoprene Surgical Glove — SEMPERMED USA, INC.
- 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 e26541d9-c68c-4cf1-bd8f-d9c7bdbefa6b 36 fields · synced Jun 20, 2026