The following data is part of a premarket notification filed by Shandong Xingyu Gloves Co., Ltd with the FDA for Xingyu Nitrile Powder Free Patient Examination Gloves, White Color.
| Device ID | K171615 |
| 510k Number | K171615 |
| Device Name: | Xingyu Nitrile Powder Free Patient Examination Gloves, White Color |
| Classification | Polymer Patient Examination Glove |
| Applicant | Shandong Xingyu Gloves Co., Ltd No.2158,Yaoqian Road,Economic Development Zone Gaomi, CN 261502 |
| Contact | Xu Qiang |
| Correspondent | Chu Xiaoan Beijing Easylink CO., LTD Rm. F302 Bldg., 41, Jing Cheng Ya Ju, Courtyard 6 Of Southern Dou Ge Zhuang, Beijing, CN 100121 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-01 |
| Decision Date | 2017-07-31 |
| Summary: | summary |