The following data is part of a premarket notification filed by Inpro Technology Device Factory with the FDA for Synthetic Vinyl Examination Gloves, Powder-free, Yellow.
| Device ID | K160468 |
| 510k Number | K160468 |
| Device Name: | Synthetic Vinyl Examination Gloves, Powder-Free, Yellow |
| Classification | Vinyl Patient Examination Glove |
| Applicant | INPRO TECHNOLOGY DEVICE FACTORY NO. 10-1, XING'AN ROAD EAST, LINQU Weifang, CN 262600 |
| Contact | Wang Yanmei |
| Correspondent | Wang Yanmei INPRO TECHNOLOGY DEVICE FACTORY NO. 10-1, XING'AN ROAD EAST, LINQU Weifang, CN 262600 |
| Product Code | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-19 |
| Decision Date | 2016-06-23 |