The following data is part of a premarket notification filed by Shandong Shengshixincheng Medical Science & Technology Co., with the FDA for Disposable Synthetic Examination Gloves.
| Device ID | K210520 |
| 510k Number | K210520 |
| Device Name: | Disposable Synthetic Examination Gloves |
| Classification | Vinyl Patient Examination Glove |
| Applicant | Shandong Shengshixincheng Medical Science & Technology Co., No.28 Aluminum Deep Processing Industrial Park, Changshan Town,Zouping Binzhou, CN 256200 |
| Contact | Ping Wang |
| 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 | 2021-02-23 |
| Decision Date | 2021-05-26 |