The following data is part of a premarket notification filed by Zibo Flourish Trading Co., Ltd. with the FDA for Powder Free Grey Vinyl Examination Gloves.
| Device ID | K161072 |
| 510k Number | K161072 |
| Device Name: | Powder Free Grey Vinyl Examination Gloves |
| Classification | Vinyl Patient Examination Glove |
| Applicant | ZIBO FLOURISH TRADING CO., LTD. NAQI ROAD, ZHANGDIAN DISTRICT Zibo, CN 255000 |
| Contact | Kou Lingling |
| Correspondent | Ray Wang BEIJING BELIEVE TECH.SERVICE CO., LTD. 5-1206, BUILD 332, DAFANGJU, NO.25 BANBIDIAN RD., LIYUAN TOWN, TONGZHOU Beijing, CN 101121 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-18 |
| Decision Date | 2016-07-14 |
| Summary: | summary |