The following data is part of a premarket notification filed by Dynarex Corporation with the FDA for Dynarex/tillotson Non-sterile Powder Free Blue Nitrile Patient Exam Glove For Use With Chemotherapy Drugs.
| Device ID | K081569 |
| 510k Number | K081569 |
| Device Name: | DYNAREX/TILLOTSON NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAM GLOVE FOR USE WITH CHEMOTHERAPY DRUGS |
| Classification | Polymer Patient Examination Glove |
| Applicant | DYNAREX CORPORATION 10 GLENSHAW ST. Orangeburg, NY 10962 |
| Contact | Vijay Sachdev |
| Correspondent | Vijay Sachdev DYNAREX CORPORATION 10 GLENSHAW ST. Orangeburg, NY 10962 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-04 |
| Decision Date | 2008-09-12 |
| Summary: | summary |