Identity
- Trade Name
- Dental City FDA UDI
- Generic Name
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- Vortex PF Nitrile Blue Gloves Medium 100/Box FDA UDI
- Model / Reference
- 14-701MD FDA UDI
- Description
- Vortex PF Nitrile Blue Gloves Medium 100/Box FDA UDI
Identifiers
- Primary DI / UDI-DI
- D77114701MD1 FDA UDI
- 510(k) Number
- K110981 FDA UDI
- FDA Product Code
- LZA FDA UDI
- GMDN Term
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6250 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dental City by Icp, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K110981 also covers:
- OmniFLEX™ Powder-Free Nitrile Medical Examination Gloves — A.M.G. Médicale Inc
- OmniFLEX™ Powder-Free Nitrile Medical Examination Gloves — A.M.G. Médicale Inc
- OmniFLEX™ Powder-Free Nitrile Medical Examination Gloves by MedPro — A.M.G. Médicale Inc
- Akers — Akers Industries, Inc.
- Schneider — Avatech Corp.
- Schneider — Avatech Corp.
- Schneider — Avatech Corp.
- Schneider — Avatech Corp.
- Schneider — Avatech Corp.
- LUXSPA Medium nitrile disposable exam gloves — Beltway Nail Supply, LLC
- LUXSPA Medium nitrile disposable exam gloves — Beltway Nail Supply, LLC
- LUXSPA Small nitrile disposable exam gloves — Beltway Nail Supply, LLC
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
- Icp, Inc.
Sources (1)
- FDA UDI 453abb9d-baa7-4edb-9626-c6aef4813c81 35 fields · synced Jun 8, 2026