Identity
- Trade Name
- Biogel® M FDA UDI
- Generic Name
- Hevea-latex surgical glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- Biogel M 8.5x50US FDA UDI
- Model / Reference
- 30585 FDA UDI
- Description
- Biogel M 8.5x50US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060097931705 FDA UDI
- FDA Product Code
- KGO FDA UDI
- GMDN Term
- Hevea-latex 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
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Hevea-latex surgical glove, non-powdered, non-antimicrobial
Biogel® M by Mölnlycke Health Care AB — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- HALYARD — Ansell Healthcare Product · 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
- Mölnlycke Health Care AB
Sources (1)
- FDA UDI 8a652442-628c-4261-ba82-6e6d1dcdd48e 35 fields · synced Jun 6, 2026