Identity
- Trade Name
- GAMMEX FDA UDI
- Generic Name
- Polychloroprene surgical glove, non-powdered FDA UDI
- Device Name
- GAMMEX® PI Glove-in-Glove™ System Half Size Larger Size 7, Sterile Powder-Free Surgical Glove, pre-donned double gloving system of one polyisoprene (PI) surgical glove and one neoprene surgical glove FDA UDI
- Model / Reference
- 340069070 FDA UDI
- Description
- GAMMEX® PI Glove-in-Glove™ System Half Size Larger Size 7, Sterile Powder-Free Surgical Glove, pre-donned double gloving system of one polyisoprene (PI) surgical glove and one neoprene surgical glove FDA UDI
Identifiers
- Catalog Number
- 340069070 FDA UDI
- Primary DI / UDI-DI
- 15414566690704 FDA UDI
- FDA Product Code
- KGO FDA UDI
- GMDN Term
- Polychloroprene surgical glove, non-powdered 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-antimicrobialPolychloroprene surgical glove, non-powdered
Gammex by Ansell Healthcare Product — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polychloroprene surgical glove, non-powdered.
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- Criterion CR Surgeons Glove — HENRY SCHEIN, INC. · Class I
- Biogel® Neoderm® — Mölnlycke Health Care AB · Class I
- Biogel® Neoderm® — Mölnlycke Health Care AB · Class I
- Sempermed Syntegra CR Chloroprene Surgical Glove — SEMPERMED USA, INC. · 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 7e9a021f-870b-4f90-a88c-29ee81cce459 36 fields · synced May 30, 2026