The following data is part of a premarket notification filed by Jiangxi Jaysun Medicare Co., Ltd. with the FDA for Jaysun Powder Free Vinyl Patient Examination Gloves, Clear (non-colored).
| Device ID | K182575 |
| 510k Number | K182575 |
| Device Name: | Jaysun Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | Jiangxi Jaysun Medicare Co., Ltd. No.1 Jaysun Road, Penghuwan Industrial Park Pengze City, Jiujiang, CN 332708 |
| Contact | Zong Run |
| Correspondent | Chu Xiaoan Beijing Easylink CO.,LTD Rm. F302 Bldg., 41, Jing Cheng Ya Ju, Courtyard 6 Of Southern Dou Ge Zhuang, Beijing, CN 100021 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-19 |
| Decision Date | 2019-05-24 |