The following data is part of a premarket notification filed by Jiangsu Standard Health Co.,ltd with the FDA for Nitrile Examination Golves Powder Free.
Device ID | K212921 |
510k Number | K212921 |
Device Name: | Nitrile Examination Golves Powder Free |
Classification | Polymer Patient Examination Glove |
Applicant | Jiangsu Standard Health Co.,Ltd 19F Fortune Tower, No.1 Wangxi Road Zhangjiagang City, CN 215600 |
Contact | Lu Tao |
Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM. 1801, No. 161 Lujiazui East 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 | 2021-09-14 |
Decision Date | 2021-12-24 |