Identity
- Trade Name
- Biogel® Neoderm® FDA UDI
- Generic Name
- Polychloroprene surgical glove, non-powdered FDA UDI
- Device Name
- Biogel NeoDerm 6.5x50 FDA UDI
- Model / Reference
- 42965 FDA UDI
- Description
- Biogel NeoDerm 6.5x50 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07332551891589 FDA UDI
- 510(k) Number
- K000421 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
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: Polychloroprene surgical glove, non-powdered
Biogel® Neoderm® by Mölnlycke Health Care AB — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polychloroprene surgical glove, non-powdered.
- Gammex — Bosma Enterprises · Class I
- Sempermed Syntegra IR Polyisoprene Surgical Glove — SEMPERMED USA, INC.
- GAMMEX — Ansell Healthcare Product · Class I
- PremierPro Surgeons Glove — SVS LLC · Class I
- Sempermed Syntegra IR Polyisoprene Surgical Glove — SEMPERMED USA, INC.
- HALYARD — Ansell Healthcare Product · Class I
- Criterion CR Surgeons Glove — HENRY SCHEIN, INC. · Class I
- HALYARD — Ansell Healthcare Product · Class I
Cleared under the same submission
K000421 also covers:
- Biogel® Neoderm® — Mölnlycke Health Care AB
- Biogel® Neoderm® — Mölnlycke Health Care AB
- Biogel® Neoderm® — Mölnlycke Health Care AB
- Biogel® Neoderm® — Mölnlycke Health Care AB
- Biogel® Neoderm® — Mölnlycke Health Care AB
- Biogel® Neoderm® — Mölnlycke Health Care AB
- Biogel® Neoderm® — Mölnlycke Health Care AB
- Biogel® Skinsense® Indicator® System — Mölnlycke Health Care AB
- Biogel® Skinsense® Indicator® System — Mölnlycke Health Care AB
- Biogel® Skinsense® Indicator® System — Mölnlycke Health Care AB
- Biogel® Skinsense® Indicator® System — Mölnlycke Health Care AB
- Biogel® Skinsense® Indicator® System — Mölnlycke Health Care AB
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 13b057cd-e7a0-45e2-a8b2-8a3ad833273a 36 fields · synced Jun 1, 2026