Cleared Traditional

POWDER FREE NITRILE SURGICAL GLOVE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS

K203030 · Wrp Asia Pacific Sdn. Bhd. · General Hospital
Jun 2021
Decision
252d
Days
Class 1
Risk

About This 510(k) Submission

K203030 is an FDA 510(k) clearance for the POWDER FREE NITRILE SURGICAL GLOVE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, a Surgeon's Gloves (Class I — General Controls, product code KGO), submitted by Wrp Asia Pacific Sdn. Bhd. (Sepang, MY). The FDA issued a Cleared decision on June 11, 2021, 252 days after receiving the submission on October 2, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 878.4460.

Submission Details

510(k) Number K203030 FDA.gov
FDA Decision Cleared SESE
Date Received October 02, 2020
Decision Date June 11, 2021
Days to Decision 252 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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