Identity
- Trade Name
- Adenna FDA UDI
- Generic Name
- Vinyl examination/treatment glove, non-powdered FDA UDI
- Device Name
- Adenna® Disposable Vinyl Exam Grade Gloves, Powder Free, Clear, 3.9 mil, Ex-Large, 90/bx, 10 bxs/cs FDA UDI
- Model / Reference
- VPF238 FDA UDI
- Description
- Adenna® Disposable Vinyl Exam Grade Gloves, Powder Free, Clear, 3.9 mil, Ex-Large, 90/bx, 10 bxs/cs FDA UDI
Identifiers
- Catalog Number
- VPF238 FDA UDI
- Primary DI / UDI-DI
- 00653195002382 FDA UDI
- 510(k) Number
- K072227 FDA UDI
- FDA Product Code
- LYZ FDA UDI
- GMDN Term
- Vinyl examination/treatment glove, non-powdered 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
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Vinyl examination/treatment glove, non-powdered
Adenna by Adenna Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Vinyl examination/treatment glove, non-powdered.
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Cleared under the same submission
K072227 also covers:
- Adenna — ADENNA LLC
- Adenna — ADENNA LLC
- Adenna — ADENNA LLC
- Adenna — ADENNA LLC
- Vinyl Guard — Bunzl USA Holdings LLC
- Vinyl Guard — Bunzl USA Holdings LLC
- Vinyl Guard — Bunzl USA Holdings LLC
- Vinyl Guard — Bunzl USA Holdings LLC
- SureCare — Ims, Inc.
- SureCare — Ims, Inc.
- SureCare — Ims, Inc.
- SureCare — Ims, Inc.
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
- Adenna Llc
Sources (1)
- FDA UDI f8bb045a-d0f9-4fc5-91c6-4482967a0acf 36 fields · synced May 30, 2026