The following data is part of a premarket notification filed by Northstar Healthcare Holdings with the FDA for Textured, Natural To Off-white, Latex, Sterile, Powder Free Examination Gloves, With Protein Labeling Claim (50 Ug/dm2 O.
| Device ID | K122788 |
| 510k Number | K122788 |
| Device Name: | TEXTURED, NATURAL TO OFF-WHITE, LATEX, STERILE, POWDER FREE EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 UG/DM2 O |
| Classification | Latex Patient Examination Glove |
| Applicant | NORTHSTAR HEALTHCARE HOLDINGS 70 SIR JOHN ROGERSONS QUAY Dublin 2, IE |
| Contact | Michael Riordan |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-09-11 |
| Decision Date | 2013-01-17 |
| Summary: | summary |