The following data is part of a premarket notification filed by Northstar Healthcare Holdings with the FDA for Blue Power Free Nitrile Examination Glove.
| Device ID | K121464 |
| 510k Number | K121464 |
| Device Name: | BLUE POWER FREE NITRILE EXAMINATION GLOVE |
| Classification | Polymer Patient Examination Glove |
| Applicant | NORTHSTAR HEALTHCARE HOLDINGS 70 SIR JOHN ROGERSONS QUAY Dublin 2, IE |
| Contact | Michael Riordan |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-05-17 |
| Decision Date | 2012-07-05 |
| Summary: | summary |