Identity
- Trade Name
- nitrylex classic blue FDA UDI
- Generic Name
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial Size: L Pack: 10 inner boxes/ carton FDA UDI
- Model / Reference
- RD30019904_0001 FDA UDI
- Description
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial Size: L Pack: 10 inner boxes/ carton FDA UDI
Identifiers
- Primary DI / UDI-DI
- 18859185201356 FDA UDI
- 510(k) Number
- K172930 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
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, non-powdered, non-antimicrobial
nitrylex classic blue by Mercator Medical (thailand) Limited — 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
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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
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Cleared under the same submission
K172930 also covers:
- nitrylex classic blue — MERCATOR MEDICAL (THAILAND) LIMITED
- nitrylex classic blue — MERCATOR MEDICAL (THAILAND) LIMITED
- nitrylex classic blue — MERCATOR MEDICAL (THAILAND) LIMITED
- nitrylex classic blue — MERCATOR MEDICAL (THAILAND) LIMITED
- nitrylex classic+ — MERCATOR MEDICAL (THAILAND) LIMITED
- nitrylex classic+ — MERCATOR MEDICAL (THAILAND) LIMITED
- nitrylex classic+ — MERCATOR MEDICAL (THAILAND) LIMITED
- nitrylex classic+ — MERCATOR MEDICAL (THAILAND) LIMITED
- nitrylex classic+ — MERCATOR MEDICAL (THAILAND) LIMITED
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
- Mercator Medical (thailand) Limited
Sources (1)
- FDA UDI e72fc4d9-d940-4ded-95d1-96a5cc04a236 35 fields · synced May 30, 2026