The following data is part of a premarket notification filed by Primus Gloves Pvt Limited with the FDA for Sterile Vinyl Examination Gloves, Powder Free.
| Device ID | K170612 |
| 510k Number | K170612 |
| Device Name: | STERILE VINYL EXAMINATION GLOVES, Powder Free |
| Classification | Vinyl Patient Examination Glove |
| 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 | LYZ |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-01 |
| Decision Date | 2017-10-23 |
| Summary: | summary |