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, Clear (non-colored).
| Device ID | K173017 |
| 510k Number | K173017 |
| Device Name: | Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | Anhui Kindguard Medical Supplies Technology Co.,Ltd Intersection Of Yulan Road And Chayang 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 | 2017-12-15 |
| Summary: | summary |