The following data is part of a premarket notification filed by Suzhou Colour-way Enterprise Development Co., Ltd. with the FDA for Powdered Latex Surgeon's Glove.
| Device ID | K121925 |
| 510k Number | K121925 |
| Device Name: | POWDERED LATEX SURGEON'S GLOVE |
| Classification | Surgeon's Gloves |
| Applicant | SUZHOU COLOUR-WAY ENTERPRISE DEVELOPMENT CO., LTD. 83 CHANGPING ROAD, DONGQIAO INDUSTRIAL AREA Suzhou, Jiangsu, CN 215152 |
| Contact | Zhu Yingqiu |
| Correspondent | Zhu Yingqiu SUZHOU COLOUR-WAY ENTERPRISE DEVELOPMENT CO., LTD. 83 CHANGPING ROAD, DONGQIAO INDUSTRIAL AREA Suzhou, Jiangsu, CN 215152 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-02 |
| Decision Date | 2013-08-28 |
| Summary: | summary |