Submission Details
| 510(k) Number | K030157 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 16, 2003 |
| Decision Date | February 19, 2003 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
Cleared
Traditional
POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING CLAIM
Feb 2003
Decision
34d
Days
Class 1
Risk
About This 510(k) Submission
K030157 is an FDA 510(k) clearance for the POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING CLAIM, a Latex Patient Examination Glove (Class I — General Controls, product code LYY), submitted by Wrp Asia Pacific Sdn. Bhd. (Sepang, MY). The FDA issued a Cleared decision on February 19, 2003, 34 days after receiving the submission on January 16, 2003. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.
Device Classification
| Product Code | LYY — Latex Patient Examination Glove |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 880.6250 |
| Definition | A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants. |
Manufacturer
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