Identity
- Trade Name
- Biogel® Diagnostic FDA UDI
- Generic Name
- Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- Biogel Diagnostic 7.5 x25 US FDA UDI
- Model / Reference
- 30375 FDA UDI
- Description
- Biogel Diagnostic 7.5 x25 US FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05055186413743 FDA UDI
- 510(k) Number
- K971514 FDA UDI
- FDA Product Code
- LYY FDA UDI
- GMDN Term
- Hevea-latex examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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 examination/treatment glove, non-powdered, non-antimicrobial
Biogel® Diagnostic by Mölnlycke Health Care AB — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K971514 also covers:
- Biogel® Diagnostic — Mölnlycke Health Care AB
- Biogel® Diagnostic — Mölnlycke Health Care AB
- Biogel® Diagnostic — Mölnlycke Health Care AB
- Biogel® Diagnostic — Mölnlycke Health Care AB
- Biogel® Diagnostic — Mölnlycke Health Care AB
- Biogel® Diagnostic — Mölnlycke Health Care AB
- Biogel® Diagnostic — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Mölnlycke Health Care AB
Sources (1)
- FDA UDI 0e6f15e1-3acc-4883-9ec4-2719962d42a9 36 fields · synced May 30, 2026