The following data is part of a premarket notification filed by Primus Gloves Pvt Limited with the FDA for Nitrile Patient Examination Gloves, Powderfree, Blue Color.
| Device ID | K143477 |
| 510k Number | K143477 |
| Device Name: | Nitrile Patient Examination Gloves, Powderfree, Blue Color |
| Classification | Polymer Patient Examination Glove |
| Applicant | PRIMUS GLOVES PVT LIMITED PLOT No: 14-A, COCHIN SPECIAL ECONOMIC ZONE, KAKKANAD Cochin, IN 682037 |
| Contact | Jose Paul M |
| Correspondent | Jose Paul M PRIMUS GLOVES PVT LIMITED PLOT No: 14-A, COCHIN SPECIAL ECONOMIC ZONE, KAKKANAD Cochin, IN 682037 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-05 |
| Decision Date | 2016-04-14 |
| Summary: | summary |