Identity
- Trade Name
- Essential Cares FDA UDI
- Generic Name
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- Nitrile Glove Powder-Free Finger Textured Blue Essential Cares Small 100pc/Bx 10Bx/Cs FDA UDI
- Model / Reference
- MGLVNPF35BL-S-ES FDA UDI
- Description
- Nitrile Glove Powder-Free Finger Textured Blue Essential Cares Small 100pc/Bx 10Bx/Cs FDA UDI
Identifiers
- Catalog Number
- MGLVNPF35BL-S-ES FDA UDI
- Primary DI / UDI-DI
- 00850018936538 FDA UDI
- 510(k) Number
- K212735 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Essential Cares by Essential Cares Supplies, Inc. — 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.
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- First Aid Only — Acme United Corporation · Class I
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Cleared under the same submission
K212735 also covers:
- Essential Cares — Essential Cares Supplies, Inc.
- Essential Cares — Essential Cares Supplies, Inc.
- Essential Cares — Essential Cares Supplies, Inc.
- Essential Cares — Essential Cares Supplies, Inc.
- Essential Cares — Essential Cares Supplies, Inc.
- Essential Cares — Essential Cares Supplies, Inc.
- Essential Cares — Essential Cares Supplies, Inc.
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
- Essential Cares Supplies, Inc.
Sources (1)
- FDA UDI be2de4b0-211c-405d-8169-2d6e1b890a38 36 fields · synced May 30, 2026