The following data is part of a premarket notification filed by Xinying Trading Co., Ltd. with the FDA for Vinyl Examination Gloves (yellow).
Device ID | K203702 |
510k Number | K203702 |
Device Name: | Vinyl Examination Gloves (Yellow) |
Classification | Vinyl Patient Examination Glove |
Applicant | Xinying Trading CO., LTD. Garden Street Dezhou, CN 253000 |
Contact | Tongguang Liu |
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 | 2020-12-18 |
Decision Date | 2021-02-12 |