Identity
- Trade Name
- Elara Brand FDA UDI
- Generic Name
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- Nitrile Examination Gloves, 3 Gram, Blue, Size Small FDA UDI
- Model / Reference
- MN101 FDA UDI
- Description
- Nitrile Examination Gloves, 3 Gram, Blue, Size Small FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847212008369 FDA UDI
- 510(k) Number
- K214110 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
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
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: Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Elara Brand by Elara Foodservice Disposables LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nitrile examination/treatment glove, non-powdered, non-antimicrobial.
- VitalGard® Nitrile — Dash Medical Gloves, Inc. · Class I
- Hongray — Grand Work Plastic Products Co., Ltd. · Class I
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- MARK3 — CARGUS INTERNATIONAL, INC · Class I
- NitriSkin XP — Medgluv Inc. · Class I
- First Aid Only — Acme United Corporation · Class I
- FINISHMASTER — Bunzl USA Holdings LLC · Class I
- Medicom AssureTouch — AMD Medicom Inc · Class I
Cleared under the same submission
K214110 also covers:
- Elara Brand — Elara Foodservice Disposables LLC
- Elara Brands — Elara Foodservice Disposables LLC
- Elara Brands — Elara Foodservice Disposables LLC
- Elara Brands — Elara Foodservice Disposables LLC
- Elara Brands — Elara Foodservice Disposables LLC
- Elara Brands — Elara Foodservice Disposables LLC
- Elara Brands — Elara Foodservice Disposables 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Elara Foodservice Disposables LLC
Sources (1)
- FDA UDI 1393fd0c-3485-4037-99d8-6dd4a53d7621 34 fields · synced Jun 8, 2026