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Disposable Vinyl Examination Gloves

EUDAMEDFDA 510(k)

Class I (EU MDR)

Ref SModel S, M, L, XL510(k) K222442

by Anhui Bytech Medical Supplies Co., Ltd.

Identity

Device Name
Disposable Vinyl Examination Gloves EUDAMED
Model / Reference
S, M, L, XL EUDAMED
S EUDAMED

Identifiers

Primary DI / UDI-DI
06974034769964 EUDAMED
Basic UDI-DI
697403476DVEGEU019X EUDAMED
510(k) Number
K222442 FDA 510(k)
FDA Product Code
LYZ FDA 510(k)
EMDN Code
T01020201 VINYL 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
Austria 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

Disposable Vinyl Examination Gloves by Anhui Bytech Medical Supplies Co., Ltd. — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Anhui Bytech Medical Supplies Co., Ltd.
EUDAMED SRN
CN-MF-000011490
Authorised Representative
SUNGO Europe B.V. NL-AR-000000247

Sources (2)

  • EUDAMED 80897619-c75a-45f3-9770-bb0f1319c0e1 61 fields · synced Aug 2, 2026
  • FDA 510(k) K222442 24 fields · synced May 18, 2026