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 |