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Nitrile examination gloves

EUDAMEDFDA 510(k)

Class I (EU MDR)

Ref KG-1303510(k) K221887

by Guangdong Kingfa Sci. & Tech. Co., Ltd.

Identity

Trade Name
Nitrile examination gloves EUDAMED
Device Name
Nitrile Examination Gloves EUDAMED
Model / Reference
KG-1303 EUDAMED

Identifiers

Primary DI / UDI-DI
16973163409403 EUDAMED
Basic UDI-DI
697316340KG-130352 EUDAMED
510(k) Number
K221887 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
Germany 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

Nitrile examination gloves by Guangdong Kingfa Sci. & Tech. Co., 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
Guangdong Kingfa Sci. & Tech. Co., Ltd.
EUDAMED SRN
CN-MF-000009520
Authorised Representative
Share info GmbH DE-AR-000005132

Sources (2)

  • EUDAMED f13cfabb-c046-41a6-a25e-f85b9ed109dc 61 fields · synced Jul 8, 2026
  • FDA 510(k) K221887 24 fields · synced May 18, 2026