The following data is part of a premarket notification filed by True Glove Factory with the FDA for Synthetic Vinyl Examination Gloves, Powder Free (blue/green) (and Multiple Labels).
| Device ID | K111012 |
| 510k Number | K111012 |
| Device Name: | SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (BLUE/GREEN) (AND MULTIPLE LABELS) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | TRUE GLOVE FACTORY NO.6-1 XINGAN ROAD EAST, LINQU Weifang, Shandong, CN 262600 |
| Contact | Frank Yang |
| Correspondent | Frank Yang TRUE GLOVE FACTORY NO.6-1 XINGAN ROAD 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 | 2011-04-12 |
| Decision Date | 2011-07-06 |