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 |