The following data is part of a premarket notification filed by Jiangsu U-med Rubber & Plastic Products Co.,ltd. with the FDA for U-med Powder Free Polyethylene Examination Gloves,blue Color.
| Device ID | K173228 |
| 510k Number | K173228 |
| Device Name: | U-MED Powder Free Polyethylene Examination Gloves,Blue Color |
| Classification | Polymer Patient Examination Glove |
| Applicant | Jiangsu U-MED Rubber & Plastic Products Co.,Ltd. Luzhuang Road, Suyu High-Tech Zone, Suqian, CN 223804 |
| Contact | Chen Ye |
| 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 | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-04 |
| Decision Date | 2018-02-20 |
| Summary: | summary |