The following data is part of a premarket notification filed by Anhui Kindguard Medical Supplies Technology Co.,ltd with the FDA for Kindguard Powder Free Vinyl Patient Examination Gloves, Light Yellow Color.
Device ID | K173016 |
510k Number | K173016 |
Device Name: | Kindguard Powder Free Vinyl Patient Examination Gloves, Light Yellow Color |
Classification | Vinyl Patient Examination Glove |
Applicant | Anhui Kindguard Medical Supplies Technology Co.,Ltd Intersection Of Yulan Road And Chaoyang Road, Sixian County Suzhou, CN 234300 |
Contact | Chen Wei |
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 | LYZ |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-27 |
Decision Date | 2017-11-15 |
Summary: | summary |