Cleared Traditional

DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS

K141982 · Wrp Asia Pacific Sdn. Bhd. · General Hospital
Feb 2015
Decision
199d
Days
Class 1
Risk

About This 510(k) Submission

K141982 is an FDA 510(k) clearance for the DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, a Medical Glove, Specialty (Class I — General Controls, product code LZC), submitted by Wrp Asia Pacific Sdn. Bhd. (Salak Tinggi, Sepang Selangor, MY). The FDA issued a Cleared decision on February 5, 2015, 199 days after receiving the submission on July 21, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K141982 FDA.gov
FDA Decision Cleared SESE
Date Received July 21, 2014
Decision Date February 05, 2015
Days to Decision 199 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LZC — Medical Glove, Specialty
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6250
Definition A Disposable Medical Glove (examination Or Surgeon?s) Is A Device That May Or May Not Bear A Trace Amount Of Residual Powder And Is Intended To Be Worn On The Hand Or Finger(s) For Medical Purposes To Prevent Contamination. In Addition, These Gloves May Have Specialty Claims Such As Chemotherapy, Etc.

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