Identity
- Trade Name
- Oasis FDA UDI
- Generic Name
- Hevea-latex surgical glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- SURGEON GLOVES,LATEX,SIZE 7.5 FDA UDI
- Model / Reference
- AHS-7.5 FDA UDI
- Description
- SURGEON GLOVES,LATEX,SIZE 7.5 FDA UDI
Identifiers
- Primary DI / UDI-DI
- B031AHS750 FDA UDI
- 510(k) Number
- K151114 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
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: Hevea-latex surgical glove, non-powdered, non-antimicrobial
Oasis by American Health Service Sales Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K151114 also covers:
- Oasis — American Health Service Sales Corporation
- Oasis — American Health Service Sales Corporation
- Oasis — American Health Service Sales Corporation
- Oasis — American Health Service Sales Corporation
- Oasis — American Health Service Sales Corporation
- Oasis — American Health Service Sales Corporation
- Amerisource Bergen — BP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANY
- Amerisource Bergen — BP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANY
- Amerisource Bergen — BP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANY
- Amerisource Bergen — BP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANY
- Amerisource Bergen — BP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANY
- Amerisource Bergen — BP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANY
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
- American Health Service Sales Corporation
Sources (1)
- FDA UDI d575c41f-cd47-4a24-9c89-c67823732c05 34 fields · synced May 30, 2026