The following data is part of a premarket notification filed by Inmed Gloves Factory with the FDA for Synthetic Vinyl Examination Glove Powder Free.
| Device ID | K111857 |
| 510k Number | K111857 |
| Device Name: | SYNTHETIC VINYL EXAMINATION GLOVE POWDER FREE |
| Classification | Vinyl Patient Examination Glove |
| Applicant | INMED GLOVES FACTORY 10-2 XING'AN RD. EAST, LINQU, Weifang, Shandong, CN 262600 |
| Contact | Xiaobing Li |
| Correspondent | Xiaobing Li INMED GLOVES FACTORY 10-2 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 | 2011-06-30 |
| Decision Date | 2011-09-21 |