K003232 is an FDA 510(k) clearance for the RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE). This device is classified as a Polymer Patient Examination Glove (Class I - General Controls, product code LZA).
Submitted by Riverstone Resources Sdn Bhd (Kepong Baru, Kuala Lumpur, MY). The FDA issued a Cleared decision on October 26, 2000, 9 days after receiving the submission on October 17, 2000.
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 | K003232 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 17, 2000 |
| Decision Date | October 26, 2000 |
| Days to Decision | 9 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. |