The following data is part of a premarket notification filed by Lutai Medical Technology Co.,ltd. with the FDA for Vinyl Examination Gloves(yellow).
| Device ID | K203666 |
| 510k Number | K203666 |
| Device Name: | Vinyl Examination Gloves(Yellow) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | Lutai Medical Technology Co.,LTD. Tiandingfeng Road Dezhou, CN 251500 |
| Contact | Xiaomeng Xiaomeng Li |
| 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 | 2020-12-16 |
| Decision Date | 2021-03-12 |