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mCare

EUDAMEDFDA 510(k)

Class I (EU MDR)

Ref RD303220Q4Ref RD303220Q5510(k) K172930

by Mercator Medical (Thailand) Ltd.

Identity

Trade Name
mCare EUDAMED
Device Name
Non-sterile Powder Free Nitrile Examination gloves EUDAMED
Model / Reference
RD303220Q4 EUDAMED
RD303220Q5 EUDAMED

Identifiers

Primary DI / UDI-DI
08859185206590 EUDAMED
08859185206606 EUDAMED
Basic UDI-DI
88591852NSNPF6S EUDAMED
510(k) Number
K172930 FDA 510(k)
FDA Product Code
LZA FDA 510(k)
EMDN Code
T01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMED

Classification

Device Class
Class I EUDAMEDFDA 510(k)
Legislation / Framework
21 CFR Part 880.6250 FDA 510(k)
Regulation Number
880.6250 FDA 510(k)
Market of Registration
Poland EUDAMED
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

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

mCare by Mercator Medical (Thailand) Ltd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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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 (3)

  • EUDAMED a65f9dac-5c86-4be3-bda8-8729ab423f99 61 fields · synced Oct 6, 2026
  • EUDAMED a6a652c1-0bd6-4cc4-907d-a571da2b0af0 61 fields · synced May 18, 2026
  • FDA 510(k) K172930 24 fields · synced May 18, 2026