The following data is part of a premarket notification filed by Chifeng Huawei Medical Science&technology Co.,ltd. with the FDA for Disposable Vinyl Examination Glove.
| Device ID | K220469 |
| 510k Number | K220469 |
| Device Name: | Disposable Vinyl Examination Glove |
| Classification | Vinyl Patient Examination Glove |
| Applicant | Chifeng Huawei Medical Science&Technology Co.,Ltd. No. 2-4, Second-stage Standardized Plant, Songshan (Anqing) Industrial Park Chifeng, CN 024023 |
| Contact | Li Xiaohong |
| 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 | 2022-02-18 |
| Decision Date | 2022-06-16 |