The following data is part of a premarket notification filed by Ansell Healthcare Products, Inc. with the FDA for Micro-touch Nitratex Sterile Nitrile Powder-free Blue Examination Gloves (chemotherapy Use).
| Device ID | K082457 |
| 510k Number | K082457 |
| Device Name: | MICRO-TOUCH NITRATEX STERILE NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE) |
| Classification | Polymer Patient Examination Glove |
| Applicant | ANSELL HEALTHCARE PRODUCTS, INC. 1635 INDUSTRIAL ROAD Dothan, AL 36303 |
| Contact | Cynthia A Ingram |
| Correspondent | Cynthia A Ingram ANSELL HEALTHCARE PRODUCTS, INC. 1635 INDUSTRIAL ROAD Dothan, AL 36303 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-26 |
| Decision Date | 2008-11-10 |
| Summary: | summary |