Cleared Traditional

Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove

K183389 · Hartalega NGC Sdn. Bhd. · General Hospital
Jun 2019
Decision
204d
Days
Class 1
Risk

About This 510(k) Submission

K183389 is an FDA 510(k) clearance for the Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove, a Surgeon's Gloves (Class I — General Controls, product code KGO), submitted by Hartalega NGC Sdn. Bhd. (Sepang, MY). The FDA issued a Cleared decision on June 28, 2019, 204 days after receiving the submission on December 6, 2018. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4460.

Submission Details

510(k) Number K183389 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 2018
Decision Date June 28, 2019
Days to Decision 204 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

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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