Cleared Traditional

Vinyl examination gloves

K230046 · Guangdong Kingfa Sci. & Tech.Co., Ltd. · General Hospital

Mar 2023

Decision

78d

Days

Class 1

Risk

About This 510(k) Submission

K230046 is an FDA 510(k) clearance for the Vinyl examination gloves, a Vinyl Patient Examination Glove (Class I — General Controls, product code LYZ), submitted by Guangdong Kingfa Sci. & Tech.Co., Ltd. (Qingyuan, CN). The FDA issued a Cleared decision on March 25, 2023, 78 days after receiving the submission on January 6, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number	K230046 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 06, 2023
Decision Date	March 25, 2023
Days to Decision	78 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.