Cleared Traditional

Disposable Vinyl Examination Gloves

K223008 · Jiangxi Handspro Products Solutions Co., Ltd. · General Hospital

Oct 2022

Decision

Days

Class 1

Risk

About This 510(k) Submission

K223008 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 Jiangxi Handspro Products Solutions Co., Ltd. (Jiujiang City, CN). The FDA issued a Cleared decision on October 8, 2022, 9 days after receiving the submission on September 29, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number	K223008 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2022
Decision Date	October 08, 2022
Days to Decision	9 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.