The following data is part of a premarket notification filed by Xinfu Medical Products Co., Ltd. with the FDA for Xinfu Powder-free Yellow Vinyl Patient Examination Gloves.
| Device ID | K152719 |
| 510k Number | K152719 |
| Device Name: | Xinfu Powder-Free Yellow Vinyl Patient Examination Gloves |
| Classification | Vinyl Patient Examination Glove |
| Applicant | XINFU MEDICAL PRODUCTS CO., LTD. EAST OF LIPINGTUO, LUANNAN COUNTY Tangshan City, CN 063502 |
| Contact | Xie Wenxing |
| Correspondent | Chu Xiaoan XINFU MEDICAL PRODUCTS CO., LTD. ROOM 1606 BLDG. 1 JIANXIANG YUAN NO. 209 BEI SI HUAN ZHONG BEI SI HUAN ZHONG ROAD, HAIDIAN DIS Beijing, CN 100083 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-21 |
| Decision Date | 2016-03-01 |
| Summary: | summary |