Submission Details
| 510(k) Number | K083408 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 18, 2008 |
| Decision Date | July 31, 2009 |
| Days to Decision | 255 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
Jul 2009
Decision
255d
Days
Class 1
Risk
About This 510(k) Submission
K083408 is an FDA 510(k) clearance for the POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, 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 July 31, 2009, 255 days after receiving the submission on November 18, 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. |
Manufacturer
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