Cleared Abbreviated

Sterile Nitrile Surgical Gloves Powder Free

K222350 · Jr Engineering & Medical Technologies (M) Sdn. Bhd. · General Hospital
Apr 2023
Decision
253d
Days
Class 1
Risk

About This 510(k) Submission

K222350 is an FDA 510(k) clearance for the Sterile Nitrile Surgical Gloves Powder Free, a Surgeon's Gloves (Class I — General Controls, product code KGO), submitted by Jr Engineering & Medical Technologies (M) Sdn. Bhd. (Hulu Selangor, MY). The FDA issued a Cleared decision on April 13, 2023, 253 days after receiving the submission on August 3, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4460.

Submission Details

510(k) Number K222350 FDA.gov
FDA Decision Cleared SESE
Date Received August 03, 2022
Decision Date April 13, 2023
Days to Decision 253 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code KGO — Surgeon's Gloves
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4460
Definition A Surgeon's Glove Is A Disposable Device Made Of Natural Rubber Latex Or Synthetic Polymers That May Or May Not Bear Powder To Facilitate Donning, And It Is Intended To Be Worn On The Hands, Usually In Surgical Settings, To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.

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