The following data is part of a premarket notification filed by Premier Medical Gloves Factory with the FDA for Synthetic Vinyl Examination Gloves, Powder Free (and Multiple Labels).
| Device ID | K111297 |
| 510k Number | K111297 |
| Device Name: | SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS) |
| Classification | Vinyl Patient Examination Glove |
| Applicant | PREMIER MEDICAL GLOVES FACTORY NO. 8-2, XING'AN RD., DONGCHENG, LINQU Weifang, Shandong, CN 262600 |
| Contact | Liang Zhao |
| Correspondent | Liang Zhao PREMIER MEDICAL GLOVES FACTORY NO. 8-2, XING'AN RD., DONGCHENG, 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 | 2011-05-09 |
| Decision Date | 2011-06-16 |