The following data is part of a premarket notification filed by Shandong Zhushi Pharmaceutical Group Co., Ltd with the FDA for Disposable Nitrile Examination Gloves.
Device ID | K203436 |
510k Number | K203436 |
Device Name: | Disposable Nitrile Examination Gloves |
Classification | Polymer 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. Room 608, No. 738, Shangcheng Rd., Pudong Shanghai, CN 200120 |
Product Code | LZA |
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 | 2021-04-28 |