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 |