The following data is part of a premarket notification filed by Yongsheng Medical Products Co., Ltd with the FDA for Powder-free Clear Vinyl Patient Examination Gloves.
| Device ID | K173078 |
| 510k Number | K173078 |
| Device Name: | Powder-free Clear Vinyl Patient Examination Gloves |
| Classification | Vinyl Patient Examination Glove |
| Applicant | Yongsheng Medical Products Co., Ltd No.277, Yangtianshan Road Qingzhou, CN 255000 |
| Contact | Jason Wei |
| Correspondent | Melo Zhang Intco Medical Industries, INC. 805 Barrington Ave Ontario, CA 91764 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-29 |
| Decision Date | 2018-03-09 |
| Summary: | summary |