FDA 510(k) clearance · back to tracker

Disposable Sterilized Latex Surgical Gloves

Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. cleared K211953 on 2022-05-25, decision: substantially equivalent

K-number

K211953

Sponsor

Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.

Device

Disposable Sterilized Latex Surgical Gloves

Class

Class I

Decision

Substantially Equivalent

Decision date

2022-05-25

Product code

KGO

Advisory committee

General, Plastic Surgery

Medical specialty

General, Plastic Surgery

Regulation number

878.4460

Official FDA record

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FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.