The following data is part of a premarket notification filed by Hengchang (dongying) Medical Technology Co., Ltd. with the FDA for Nitrile Exam Gloves, Powder Free,blue (tested For Use With Chemotherapy).
Device ID | K211714 |
510k Number | K211714 |
Device Name: | Nitrile Exam Gloves, Powder Free,Blue (Tested For Use With Chemotherapy) |
Classification | Polymer Patient Examination Glove |
Applicant | Hengchang (Dongying) Medical Technology Co., Ltd. Room 101,Building 2,No.26 Xinghe Road,Niuzhuang Town, Dongying District Dongying, CN |
Contact | Li Jing |
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 | 2021-06-03 |
Decision Date | 2021-08-04 |