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 (and Multiple Labels).
| Device ID | K112610 |
| 510k Number | K112610 |
| Device Name: | SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | INPRO TECHNOLOGY DEVICE FACTORY NO 10-1, XING'AN RD EAST LINQU Weifang, Shandong, CN 262600 |
| Contact | Meixia Wang |
| Correspondent | Meixia Wang INPRO TECHNOLOGY DEVICE FACTORY NO 10-1, XING'AN RD EAST LINQU Weifang, Shandong, 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 | 2011-09-07 |
| Decision Date | 2011-12-05 |