Identity
- Trade Name
- SW FDA UDI
- Generic Name
- Polychloroprene examination/treatment glove, non-powdered FDA UDI
- Device Name
- PowerChem Neoprene Exam Gloves, Extra Small FDA UDI
- Model / Reference
- K001401 FDA UDI
- Description
- PowerChem Neoprene Exam Gloves, Extra Small FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00616489105619 FDA UDI
- FDA Product Code
- LZA FDA UDI
- GMDN Term
- Polychloroprene 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Polychloroprene examination/treatment glove, non-powdered
Sw by Sw Safety Solutions Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Polychloroprene examination/treatment glove, non-powdered.
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- BLOSSOM — Mexpo International, Inc. · Class I
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- Cranberry — ASCEND EAGLE INCORPORATED · Class I
- The Orthodontic Store — Young Innovations, Inc. · Class I
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
- Sw Safety Solutions Inc.
Sources (1)
- FDA UDI 03e7418f-effb-49ab-9048-daf99f49433b 33 fields · synced May 30, 2026