The following data is part of a premarket notification filed by Best Care Trading Co., Ltd with the FDA for Disposable Vinyl Glove.
Device ID | K202008 |
510k Number | K202008 |
Device Name: | Disposable Vinyl Glove |
Classification | Vinyl Patient Examination Glove |
Applicant | Best Care Trading Co., LTD Yuying Village, Fangzhen, Zhangdian District Zibo, CN 255000 |
Contact | Chongfeng Zhao |
Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM. 608, No. 738, Shangcheng Rd., Pudong Shanghai, CN 200120 |
Product Code | LYZ |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2020-07-21 |
Decision Date | 2020-09-10 |