K083717 is an FDA 510(k) clearance for the POWDER FREE NITRILE EXAMINATION GLOVES, BUBBLE GUM SCENTED, PINK. This device is classified as a Polymer Patient Examination Glove (Class I - General Controls, product code LZA).
Submitted by Gx Corporation Sdn Bhd (Klang, Selang Darul Ehsan, MY). The FDA issued a Cleared decision on January 30, 2009, 46 days after receiving the submission on December 15, 2008.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6250. A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers 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..
| 510(k) Number | K083717 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 2008 |
| Decision Date | January 30, 2009 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | LZA - Polymer Patient Examination Glove |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6250 |
| Definition | A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers 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. |