Cleared Traditional

Disposable Vinyl Examination Gloves

K241252 · Anqing Pukang Medical Technology Co., Ltd. · General Hospital

May 2024

Decision

17d

Days

Class 1

Risk

About This 510(k) Submission

K241252 is an FDA 510(k) clearance for the Disposable Vinyl Examination Gloves, a Vinyl Patient Examination Glove (Class I — General Controls, product code LYZ), submitted by Anqing Pukang Medical Technology Co., Ltd. (Anqing, CN). The FDA issued a Cleared decision on May 20, 2024, 17 days after receiving the submission on May 3, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number	K241252 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 03, 2024
Decision Date	May 20, 2024
Days to Decision	17 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	LYZ — Vinyl Patient Examination Glove
Device Class	Class I — General Controls
CFR Regulation	21 CFR 880.6250
Definition	A Vinyl Patient Examination Glove Is A Disposable Device Made Of Poly(vinyl Chloride) That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.