Submission Details
| 510(k) Number | K083305 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 10, 2008 |
| Decision Date | June 18, 2009 |
| Days to Decision | 220 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
POWDER FREE NITRILE EXAMINATION GLOVES, STERILE WITH CHEMOTHERAPY CLAIM
Jun 2009
Decision
220d
Days
Class 1
Risk
About This 510(k) Submission
K083305 is an FDA 510(k) clearance for the POWDER FREE NITRILE EXAMINATION GLOVES, STERILE WITH CHEMOTHERAPY CLAIM, 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 June 18, 2009, 220 days after receiving the submission on November 10, 2008. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.
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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