Cleared Traditional

POWDER FREE BLUE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL

K083409 · Wrp Asia Pacific Sdn. Bhd. · General Hospital
Jul 2009
Decision
253d
Days
Class 1
Risk

About This 510(k) Submission

K083409 is an FDA 510(k) clearance for the POWDER FREE BLUE LATEX PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS WITH A PROTEIN CONTENT LABEL, 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 July 29, 2009, 253 days after receiving the submission on November 18, 2008. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K083409 FDA.gov
FDA Decision Cleared SESE
Date Received November 18, 2008
Decision Date July 29, 2009
Days to Decision 253 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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