Cleared Traditional

Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential

K241528 · Comfort Rubber Gloves Industries Sdn. Bhd. · General Hospital
Aug 2024
Decision
68d
Days
Class 1
Risk

About This 510(k) Submission

K241528 is an FDA 510(k) clearance for the Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential, a Polymer Patient Examination Glove (Class I — General Controls, product code LZA), submitted by Comfort Rubber Gloves Industries Sdn. Bhd. (Matang, MY). The FDA issued a Cleared decision on August 6, 2024, 68 days after receiving the submission on May 30, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K241528 FDA.gov
FDA Decision Cleared SESE
Date Received May 30, 2024
Decision Date August 06, 2024
Days to Decision 68 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LZA — Polymer Patient Examination Glove
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6250
Definition A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers 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.

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