The following data is part of a premarket notification filed by Industrial Clothings, Ltd. with the FDA for Midas Touch Latex Examination Gloves-polymer Coated, Powder Free.
| Device ID | K021465 |
| 510k Number | K021465 |
| Device Name: | MIDAS TOUCH LATEX EXAMINATION GLOVES-POLYMER COATED, POWDER FREE |
| Classification | Latex Patient Examination Glove |
| Applicant | INDUSTRIAL CLOTHINGS, LTD. 481A, PRINCE OF WALES AVE. Colombo 14, LK |
| Contact | Umair Ahmed |
| Correspondent | Umair Ahmed INDUSTRIAL CLOTHINGS, LTD. 481A, PRINCE OF WALES AVE. Colombo 14, LK |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-07 |
| Decision Date | 2002-05-22 |