Cleared Abbreviated

Blue Latex Examination Powder Free Gloves

K192329 · Jr Engineering & Medical Technologies (M) Sdn. Bhd. · General Hospital

Nov 2019

Decision

90d

Days

Class 1

Risk

About This 510(k) Submission

K192329 is an FDA 510(k) clearance for the Blue Latex Examination Powder Free Gloves, 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 November 25, 2019, 90 days after receiving the submission on August 27, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number	K192329 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 27, 2019
Decision Date	November 25, 2019
Days to Decision	90 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.