The following data is part of a premarket notification filed by Yurun Glove Co., Ltd. with the FDA for Vinyl Patient Examination Glove (yellow).
| Device ID | K173561 |
| 510k Number | K173561 |
| Device Name: | Vinyl Patient Examination Glove (Yellow) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | Yurun Glove Co., Ltd. No. 10 Zhaocai Street, Luannan County Shitangshan, CN 063000 |
| Contact | Chao Kevin |
| Correspondent | Ray Wang Beijing Believe-Med Technology Service Co., Ltd. 5-402, Building #27, No. 56, LiangXiang East Rd., FangShan District Beijing, CN 102401 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-17 |
| Decision Date | 2018-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860002339603 | K173561 | 000 |