Cleared Traditional

Non Sterile Powder Free Latex Examination Glove

K221667 · New Era Medicare Sdn. Bhd. · General Hospital

Oct 2022

Decision

142d

Days

Class 1

Risk

About This 510(k) Submission

K221667 is an FDA 510(k) clearance for the Non Sterile Powder Free Latex Examination Glove, a Latex Patient Examination Glove (Class I — General Controls, product code LYY), submitted by New Era Medicare Sdn. Bhd. (Teluk Intan, MY). The FDA issued a Cleared decision on October 28, 2022, 142 days after receiving the submission on June 8, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number	K221667 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 08, 2022
Decision Date	October 28, 2022
Days to Decision	142 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement

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.