The following data is part of a premarket notification filed by Beijing Reagent Latex Products Co., Ltd. with the FDA for Powdered Latex Surgical Glove.
| Device ID | K062797 |
| 510k Number | K062797 |
| Device Name: | POWDERED LATEX SURGICAL GLOVE |
| Classification | Surgeon's Gloves |
| Applicant | BEIJING REAGENT LATEX PRODUCTS CO., LTD. 1676 VILLAGE GREEN Crofton, MD 21114 |
| Contact | Ryan Barr |
| Correspondent | Ryan Barr BEIJING REAGENT LATEX PRODUCTS CO., LTD. 1676 VILLAGE GREEN Crofton, MD 21114 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-19 |
| Decision Date | 2007-04-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16936610210311 | K062797 | 000 |
| 16936610210304 | K062797 | 000 |
| 16936610210298 | K062797 | 000 |
| 16936610210281 | K062797 | 000 |
| 16936610210274 | K062797 | 000 |
| 16936610210267 | K062797 | 000 |
| 16936610210250 | K062797 | 000 |
| 16936610210243 | K062797 | 000 |
| 16936610210236 | K062797 | 000 |