Cleared Abbreviated

JR MEDIC

K222348 · Jr Engineering & Medical Technologies (M) Sdn. Bhd. · General Hospital

Oct 2022

Decision

85d

Days

Class 1

Risk

About This 510(k) Submission

K222348 is an FDA 510(k) clearance for the JR MEDIC, a Latex Patient Examination Glove (Class I — General Controls, product code LYY), submitted by Jr Engineering & Medical Technologies (M) Sdn. Bhd. (Hulu Selangor, MY). The FDA issued a Cleared decision on October 27, 2022, 85 days after receiving the submission on August 3, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number	K222348 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 03, 2022
Decision Date	October 27, 2022
Days to Decision	85 days
Submission Type	Abbreviated
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.