Cleared Traditional

Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)

K223298 · Shandong Intco Medical Products Co, Ltd. · General Hospital

Feb 2023

Decision

118d

Days

Class 1

Risk

About This 510(k) Submission

K223298 is an FDA 510(k) clearance for the Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L), a Latex Patient Examination Glove (Class I — General Controls, product code LYY), submitted by Shandong Intco Medical Products Co, Ltd. (Qingzhou, CN). The FDA issued a Cleared decision on February 22, 2023, 118 days after receiving the submission on October 27, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number	K223298 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 27, 2022
Decision Date	February 22, 2023
Days to Decision	118 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	LYY — Latex Patient Examination Glove
Device Class	Class I — General Controls
CFR Regulation	21 CFR 880.6250
Definition	A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex 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.