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Safe-Touch Vinyl Examination Gloves, Powder-Free
FDA UDIFDA 510(k)Class I (US FDA UDI)
510(k) K894686
Identity
- Trade Name
- Safe-Touch Vinyl Examination Gloves, Powder-Free FDA UDI
- Generic Name
- Vinyl examination/treatment glove, non-powdered FDA UDI
- Device Name
- Safe-Touch Vinyl Examination Gloves, Powder-Free, Ambidextrous, Medium FDA UDI
- Model / Reference
- 2612 FDA UDI
- Description
- Safe-Touch Vinyl Examination Gloves, Powder-Free, Ambidextrous, Medium FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00616784261225 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
No
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
Safe-Touch Vinyl Examination Gloves, Powder-Free by Dynarex Corp. — Class I — FDA_510K — listed in FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K894686 | Class I | Active |
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Manufacturer
- Manufacturer
- Dynarex Corp.
Sources (2)
- FDA UDI 0b10b3cd-8155-400a-bc0d-289206fa1a58 57 fields · synced Jun 18, 2026
- FDA 510(k) K894686 1 fields · synced Jun 4, 2026