The following data is part of a premarket notification filed by Zibo Yue Fan Medical Products Co, Ltd. with the FDA for Powder-free Clear Vinyl Patient Examination Gloves.
| Device ID | K170735 |
| 510k Number | K170735 |
| Device Name: | Powder-Free Clear Vinyl Patient Examination Gloves |
| Classification | Vinyl Patient Examination Glove |
| Applicant | Zibo Yue Fan Medical Products Co, Ltd. No.108 Wanjie Road. Yuqiao Industrial Park Zibo, CN 255000 |
| Contact | Wu Xiaoli |
| Correspondent | Kevin Wang 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 | 2017-03-10 |
| Decision Date | 2017-06-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850063139076 | K170735 | 000 |
| 00850063139069 | K170735 | 000 |
| 00850063139052 | K170735 | 000 |
| 00850063139007 | K170735 | 000 |