The following data is part of a premarket notification filed by Better Health Medical Products Co., Ltd. with the FDA for Disposable Vinyl Glove.
| Device ID | K202010 |
| 510k Number | K202010 |
| Device Name: | Disposable Vinyl Glove |
| Classification | Vinyl Patient Examination Glove |
| Applicant | Better Health Medical Products Co., Ltd. Zhangliu Road, Zhangdian District Zibo, CN 255087 |
| Contact | Xiaomeng Li |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room608,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 | 2020-10-16 |