The following data is part of a premarket notification filed by Shanghai Jinxiang Latex Products Co., Ltd with the FDA for Tulip Natural Rubber Latex Surgeon's Glove (powdered).
| Device ID | K142992 |
| 510k Number | K142992 |
| Device Name: | TULIP Natural Rubber Latex Surgeon's Glove (Powdered) |
| Classification | Surgeon's Gloves |
| Applicant | SHANGHAI JINXIANG LATEX PRODUCTS CO., LTD No.36 Leizhou Road, Xinghuo Development Area Fengxian District Shanghai, CN 201419 |
| Contact | Xiaoyan Wang |
| 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 | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-16 |
| Decision Date | 2015-03-18 |
| Summary: | summary |