The following data is part of a premarket notification filed by Hebei Hongtai Plastic Products Company Limited with the FDA for Vinyl Examination Gloves (white), Vinyl Examination Gloves (blue), Vinyl Examination Gloves (yellow).
| Device ID | K163168 |
| 510k Number | K163168 |
| Device Name: | Vinyl Examination Gloves (White), Vinyl Examination Gloves (Blue), Vinyl Examination Gloves (Yellow) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | HEBEI HONGTAI PLASTIC PRODUCTS COMPANY LIMITED NO. 15, LUBAN ROAD, JULU COUNTY Xingtai, CN 055250 |
| Contact | Liu Wei |
| Correspondent | Ray Wang BEIJING BELIEVE TECH.SERVICE CO., LTD. 5-1206, BUILD 332, DAFANGJU, NO.25 BANBIDIAN RD., LIYUAN TONGZHOU DISTRICT 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 | 2016-11-14 |
| Decision Date | 2017-02-23 |
| Summary: | summary |