K033777 is an FDA 510(k) clearance for the ULTRASENSE AF BLUE POWDER-FREE NITRILE EXAMINATION GLOVES. This device is classified as a Polymer Patient Examination Glove (Class I - General Controls, product code LZA).
Submitted by Syntex Healthcare Products Co., Ltd. (Reno, US). The FDA issued a Cleared decision on February 5, 2004, 63 days after receiving the submission on December 4, 2003.
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 | K033777 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 04, 2003 |
| Decision Date | February 05, 2004 |
| Days to Decision | 63 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. |