The following data is part of a premarket notification filed by Primus Gloves Pvt Limited with the FDA for Sterile Nitrile Surgical Gloves, Powder-free.
| Device ID | K170515 |
| 510k Number | K170515 |
| Device Name: | Sterile Nitrile Surgical Gloves, Powder-free |
| Classification | Surgeon's Gloves |
| Applicant | Primus Gloves PVT Limited Plot No 14A, Cochin Special Economic Zone, Kakkanad Cochin, IN 682037 |
| Contact | Jose Paul M |
| Correspondent | Jose Paul M Primus Gloves PVT Limited Plot No 14A, Cochin Special Economic Zone, Kakkanad Cochin, IN 682037 |
| Product Code | KGO |
| CFR Regulation Number | 878.4460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-21 |
| Decision Date | 2017-06-09 |
| Summary: | summary |