Cleared Traditional

Powder Free Natural Rubber Latex Examination Gloves ? Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein

K250069 · Comfort Rubber Gloves Industries Sdn. Bhd. · General Hospital

Apr 2025

Decision

109d

Days

Class 1

Risk

About This 510(k) Submission

K250069 is an FDA 510(k) clearance for the Powder Free Natural Rubber Latex Examination Gloves ? Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein, a Latex Patient Examination Glove (Class I — General Controls, product code LYY), submitted by Comfort Rubber Gloves Industries Sdn. Bhd. (Matang, MY). The FDA issued a Cleared decision on April 29, 2025, 109 days after receiving the submission on January 10, 2025. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number	K250069 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 10, 2025
Decision Date	April 29, 2025
Days to Decision	109 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.