Identity
- Trade Name
- Biogel FDA UDI
- Generic Name
- Polychloroprene surgical glove, non-powdered FDA UDI
- Device Name
- Biogel Skinsense Indicator Underglove Surgical 7.0 - 50 Pair/Box FDA UDI
- Model / Reference
- 71-40670 FDA UDI
- Description
- Biogel Skinsense Indicator Underglove Surgical 7.0 - 50 Pair/Box FDA UDI
Identifiers
- Catalog Number
- 71-40670 FDA UDI
- Primary DI / UDI-DI
- 10818634023831 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
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Polychloroprene surgical glove, non-powdered
Biogel Skinsense Indicator Underglove Surgical 7.0 provides a reliable and effective means of monitoring patient safety during surgical procedures, ensuring the protection of both the healthcare provider and their patients. This single-use, polychloroprene surgical glove is designed to shield against microorganisms and reduce the risk of allergy to latex, making it an ideal choice for medical professionals.
Similar devices
Also classified as Polychloroprene surgical glove, non-powdered.
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Authorization Coverage (1 country)
Regulatory Authorizations
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
- Bosma Enterprises
Sources (1)
- FDA UDI 9748d626-6f01-4fa3-9113-79835648bd3c 37 fields · synced Jul 25, 2026