The following data is part of a premarket notification filed by Xingyuan Plastic Products Co., Ltd. with the FDA for Vinyl Patient Examination Glove, Powder Free.
| Device ID | K153159 |
| 510k Number | K153159 |
| Device Name: | Vinyl Patient Examination Glove, Powder Free |
| Classification | Vinyl Patient Examination Glove |
| Applicant | XINGYUAN PLASTIC PRODUCTS CO., LTD. #100, CHANGDA ROAD, SIGEZHUANG, LUANNAN COUNTY Tangshan, CN 063503 |
| Contact | Qiwei Xing |
| Correspondent | Ray Wang BEIJING BELIEVE TECH. SERVICE CO., LTD. 1-202, BUILD 3, BEIJING NEW WORLD, NO.5 CHAOYANG RD., CHAOYANG DISTRICT Beijing, CN 100024 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-02 |
| Decision Date | 2016-01-26 |
| Summary: | summary |