The following data is part of a premarket notification filed by Anhui Powerguard Technology Co.,ltd with the FDA for Powder Free Vinyl Patient Examination Gloves, Clear (non-colored).
Device ID | K191292 |
510k Number | K191292 |
Device Name: | Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
Classification | Vinyl Patient Examination Glove |
Applicant | Anhui Powerguard Technology Co.,Ltd North Development Zone, Lingbi County Jiujiang, CN 234200 |
Contact | Nike Dai |
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 | 2019-05-14 |
Decision Date | 2019-11-05 |