The following data is part of a premarket notification filed by Anhui Bytech Medical Supplies Co., Ltd. with the FDA for Disposable Vinyl Examination Gloves (pink, Black, Blue).
| Device ID | K222442 |
| 510k Number | K222442 |
| Device Name: | DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | Anhui Bytech Medical Supplies Co., Ltd. LingBi Economic Development Zone(North) SuZhou City, CN 234200 |
| Contact | Lijun Chen |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM. 1801, No. 161 Lujiazui East 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 | 2022-08-12 |
| Decision Date | 2022-09-28 |