The following data is part of a premarket notification filed by Northstar Healthcare Holdings with the FDA for Blue Powdered Nitrile Examination Glove.
| Device ID | K122998 |
| 510k Number | K122998 |
| Device Name: | BLUE POWDERED NITRILE EXAMINATION GLOVE |
| Classification | Polymer Patient Examination Glove |
| Applicant | NORTHSTAR HEALTHCARE HOLDINGS 1202 SOUTH ROUTE 31 Mchenry, IL 60050 |
| Contact | Anthony Giaccio |
| 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 | 2012-09-27 |
| Decision Date | 2012-11-06 |
| Summary: | summary |