The following data is part of a premarket notification filed by Better Care Plastic Technology Co., Ltd with the FDA for Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs (blue).
Device ID | K182600 |
510k Number | K182600 |
Device Name: | Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs (Blue) |
Classification | Polymer Patient Examination Glove |
Applicant | Better Care Plastic Technology Co., Ltd Fuqian Xi Road, West District Of Shenze Industrial Base, Shenze County Shenze County, CN 050000 |
Contact | Zhu Chuyan |
Correspondent | Kathy Liu Hongray USA Medical Products Inc 3973 Schaefer Avenue, Chino, CA 91810, USA Chino, CA 91810 |
Product Code | LZA |
CFR Regulation Number | 880.6250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-09-21 |
Decision Date | 2018-11-30 |
Summary: | summary |