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 |