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Pristine Care ® Powder Free Nitrile Examination Gloves, Accelerator-free, White…

EUDAMED

Class I (EU MDR)

Ref NGPF-41WModel NGPF

by Alliance Rubber Products Sdn. Bhd.

Identity

Trade Name
Pristine Care ® Powder Free Nitrile Examination Gloves, Accelerator-free, White, size M EUDAMED
Device Name
Powder Free Nitrile Examination Gloves EUDAMED
Model / Reference
NGPF EUDAMED
NGPF-41W EUDAMED

Identifiers

Primary DI / UDI-DI
09555867104985 EUDAMED
Basic UDI-DI
955586710NGPFR8 EUDAMED
Unit of Use DI
29555867104989 EUDAMED
EMDN Code
T01020204 NITRILE EXAMINATION / TREATMENT GLOVES EUDAMED

Classification

Device Class
Class I EUDAMED
Market of Registration
Austria EUDAMED

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

Pristine Care ® Powder Free Nitrile Examination Gloves, Accelerator-free, White… by Alliance Rubber Products Sdn. Bhd. — Class I — MDR — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDR

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Manufacturer

EUDAMED SRN
MY-MF-000008415
Authorised Representative
Obelis s.a. BE-AR-000000106

Sources (1)

  • EUDAMED 02ca8aba-ba57-4fcd-98ca-534eca30fcdd 61 fields · synced Jun 18, 2026