Identity
- Trade Name
- Akers FDA UDI
- Generic Name
- Nitrile examination/treatment glove, powdered FDA UDI
- Device Name
- Medium powder free black nitrile examination gloves FDA UDI
- Model / Reference
- bn102 FDA UDI
- Description
- Medium powder free black nitrile examination gloves FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00759326041227 FDA UDI
- 510(k) Number
- K103670 FDA UDI
- FDA Product Code
- LZA FDA UDI
- GMDN Term
- Nitrile examination/treatment glove, 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Nitrile examination/treatment glove, powdered
Akers by Akers Industries, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nitrile examination/treatment glove, powdered.
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- MocareHealth — Shanghai Motex Healthcare Co., Ltd. · Class I
- LUXSPA Extra Small nitrile disposable exam gloves — Beltway Nail Supply, LLC · Class I
Cleared under the same submission
K103670 also covers:
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
- Akers Industries, Inc.
Sources (1)
- FDA UDI 410d03aa-2bcb-42b3-854c-4c87fa5fa667 34 fields · synced May 30, 2026