K000650 is an FDA 510(k) clearance for the BETEL POWDER FREE LATEX EXAM GLOVES. This device is classified as a Latex Patient Examination Glove (Class I - General Controls, product code LYY).
Submitted by Betel Care Sdn. Bhd. (Selangor Darul Ehsan, MY). The FDA issued a Cleared decision on April 20, 2000, 52 days after receiving the submission on February 28, 2000.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6250. 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..
| 510(k) Number | K000650 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 2000 |
| Decision Date | April 20, 2000 |
| Days to Decision | 52 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| 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. |