The following data is part of a premarket notification filed by Shandong Zhushi Pharmaceutical Group Co., Ltd with the FDA for Disposable Vinyl Examination Gloves.
| Device ID | K203439 |
| 510k Number | K203439 |
| Device Name: | Disposable Vinyl Examination Gloves |
| Classification | Vinyl Patient Examination Glove |
| Applicant | Shandong Zhushi Pharmaceutical Group Co., Ltd No.6 Shande Road, Shan County Heze, CN 274300 |
| Contact | Junhui Zhu |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room608,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 | 2020-11-23 |
| Decision Date | 2021-02-26 |