The following data is part of a premarket notification filed by Shandong Hengya Packaging Printing Co.,ltd with the FDA for Powder Free Nitrile Examination Gloves (white, Cobalt Blue, Blue And Violet Blue).
| Device ID | K182640 |
| 510k Number | K182640 |
| Device Name: | Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue And Violet Blue) |
| Classification | Polymer Patient Examination Glove |
| Applicant | Shandong Hengya Packaging Printing Co.,Ltd Hetou Village, Yingqiu Town, Changle County, Weifang City, CN 262416 |
| Contact | Sunny Hu |
| Correspondent | Sunny Hu Shandong Hengya Packaging Printing Co.,Ltd Hetou Village, Yingqiu Town, Changle County, Weifang City, CN 262416 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-24 |
| Decision Date | 2019-04-12 |