Identity
- Trade Name
- PurCel Labs Medium Vinyl Exam Gloves FDA UDI
- Generic Name
- Vinyl examination/treatment glove, non-powdered FDA UDI
- Device Name
- Clear Vinyl Exam Gloves, Size Medium, Medical Grade, Ambidextrous, Latex-Free, Powder-Free, Single Use, Non-Sterile, (150/Box). FDA UDI
- Model / Reference
- 1201-150 FDA UDI
- Description
- Clear Vinyl Exam Gloves, Size Medium, Medical Grade, Ambidextrous, Latex-Free, Powder-Free, Single Use, Non-Sterile, (150/Box). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810143550252 FDA UDI
- 510(k) Number
- K102444 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Vinyl examination/treatment glove, non-powdered
PurCel Labs Medium Vinyl Exam Gloves by Purcel Labs 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
K102444 also covers:
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- Curaplex — BOUND TREE MEDICAL, LLC
- 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
- BASIC — Intco Medical Industries, Inc.
- BASIC — Intco Medical Industries, Inc.
- BASIC — Intco Medical Industries, Inc.
- BASIC — Intco Medical Industries, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Purcel Labs LLC
Sources (1)
- FDA UDI 9ca5624d-6612-4ebe-b9e8-983c01f25d05 35 fields · synced Jun 8, 2026