K002087 is an FDA 510(k) clearance for the BESTEX POWDER-FREE LATEX EXAM GLOVES WITH LABELING CLAIM. (50 MICROGRAMS OR LESS). This device is classified as a Latex Patient Examination Glove (Class I - General Controls, product code LYY).
Submitted by Qingdao Bestex Rubber & Plastic Products Co., Ltd. (Sunnyvale, US). The FDA issued a Cleared decision on September 13, 2000, 65 days after receiving the submission on July 10, 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 | K002087 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 10, 2000 |
| Decision Date | September 13, 2000 |
| Days to Decision | 65 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. |