Identity
- Trade Name
- nitrylex classic A100 EUDAMEDnitrylex classic blue FDA UDI
- Generic Name
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
- Device Name
- Non-sterile Powder Free Nitrile Examination gloves EUDAMEDNitrile examination/treatment glove, non-powdered, non-antimicrobial Size: XL Pack: 100 pieces by weight / inner box FDA UDI
- Model / Reference
- RD300199Q5 EUDAMEDRD30019905_0001 FDA UDI
- Description
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial Size: XL Pack: 100 pieces by weight / inner box FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08859185201366 EUDAMEDFDA UDI
- Basic UDI-DI
- 88591852NSNPF6S EUDAMED
- 510(k) Number
- K172930 FDA UDI
- FDA Product Code
- LZA FDA UDI
- EMDN Code
- T01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMED
- GMDN Term
- Nitrile examination/treatment glove, non-powdered, non-antimicrobial FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.6250 FDA UDI
- Market of Registration
- Poland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
nitrylex classic A100 by Mercator Medical (Thailand) Ltd. — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 88591852NSNPF6S | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Mercator Medical (Thailand) Ltd.
- EUDAMED SRN
- TH-MF-000042229
- Authorised Representative
- Mercator Medical S.A. PL-AR-000029843
Sources (2)
- EUDAMED 8206c67f-c7a9-49a5-a330-9de254f795a8 61 fields · synced Oct 6, 2026
- FDA UDI 43fb16ae-2c59-43bd-a9b9-8f9484573f24 35 fields · synced May 30, 2026