Cleared Traditional

Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour)

K211758 · Hartalega NGC Sdn. Bhd. · General Hospital

Aug 2021

Decision

57d

Days

Class 1

Risk

About This 510(k) Submission

K211758 is an FDA 510(k) clearance for the Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour), a Powder-free Polychloroprene Patient Examination Glove (Class I — General Controls, product code OPC), submitted by Hartalega NGC Sdn. Bhd. (Sepang, MY). The FDA issued a Cleared decision on August 3, 2021, 57 days after receiving the submission on June 7, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number	K211758 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 07, 2021
Decision Date	August 03, 2021
Days to Decision	57 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement

Device Classification

Product Code	OPC — Powder-free Polychloroprene Patient Examination Glove
Device Class	Class I — General Controls
CFR Regulation	21 CFR 880.6250
Definition	A Powder Free Polychloroprene Patient Examination Glove Is A Disposable Device Made Of Polychloroprene Rubber Tthat Bears Powder To Facilitate Donning, And Is Intended To Be Worn On The Hand For Medical Purposes To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.