The following data is part of a premarket notification filed by Zibo Yahao Supplies Co., Ltd with the FDA for Powder Free Nitrile Examination Gloves (cobalt Blue, Black, Blue And Violet Blue).
Device ID | K182612 |
510k Number | K182612 |
Device Name: | Powder Free Nitrile Examination Gloves (Cobalt Blue, Black, Blue And Violet Blue) |
Classification | Polymer Patient Examination Glove |
Applicant | Zibo Yahao Supplies Co., LTD The 6th Floor, NO.8, Niushan Road, Linzi Area Zibo, CN 255414 |
Contact | Fiona Xin |
Correspondent | Fiona Xin Zibo Yahao Supplies Co., LTD The 6th Floor, NO.8, Niushan Road, Linzi Area Zibo, CN 255414 |
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 | 2019-05-10 |