The following data is part of a premarket notification filed by Northstar Healthcare Holdings Limited with the FDA for Powder Free Latex Patient Exam Glove With Protein Labeling Claim (50 Micrograms Per Dm Squared Or Less Of Water Soluble.
| Device ID | K112988 |
| 510k Number | K112988 |
| Device Name: | POWDER FREE LATEX PATIENT EXAM GLOVE WITH PROTEIN LABELING CLAIM (50 MICROGRAMS PER DM SQUARED OR LESS OF WATER SOLUBLE |
| Classification | Latex Patient Examination Glove |
| Applicant | NORTHSTAR HEALTHCARE HOLDINGS LIMITED 1202 SOUTH ROUTE 31 Mchenry, IL 60050 |
| Contact | Antonio L Giaccio |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-10-06 |
| Decision Date | 2011-11-09 |
| Summary: | summary |