The following data is part of a premarket notification filed by Industrial Clothings, Ltd. with the FDA for Midas Touch Blue Latex Examination Gloves - Powder Free For Chemotherapy Use.
| Device ID | K033496 |
| 510k Number | K033496 |
| Device Name: | MIDAS TOUCH BLUE LATEX EXAMINATION GLOVES - POWDER FREE FOR CHEMOTHERAPY USE |
| Classification | Latex Patient Examination Glove |
| Applicant | INDUSTRIAL CLOTHINGS, LTD. 255 DUNCANMILL ROAD SUITE 904 Toronto, CA M3b 3h9 |
| Contact | Albina Bianchi |
| Correspondent | Albina Bianchi INDUSTRIAL CLOTHINGS, LTD. 255 DUNCANMILL ROAD SUITE 904 Toronto, CA M3b 3h9 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-05 |
| Decision Date | 2004-03-09 |