The following data is part of a premarket notification filed by Northstar Healthcare Holdings with the FDA for Ets Blue Powder-free Patient Nitrile Examination Gloves.
| Device ID | K121947 |
| 510k Number | K121947 |
| Device Name: | ETS BLUE POWDER-FREE PATIENT NITRILE EXAMINATION GLOVES |
| Classification | Polymer Patient Examination Glove |
| Applicant | NORTHSTAR HEALTHCARE HOLDINGS HAMILTON HOUSE, 10 QUEEN ST Hamilton, Bermuda, IE Hm11 |
| Contact | Wesley Toavs |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-07-03 |
| Decision Date | 2012-09-10 |
| Summary: | summary |