The following data is part of a premarket notification filed by Industrial Clothings, Ltd. with the FDA for Midas Touch Nitrile Examination Gloves-powderfree.
| Device ID | K000138 |
| 510k Number | K000138 |
| Device Name: | MIDAS TOUCH NITRILE EXAMINATION GLOVES-POWDERFREE |
| Classification | Polymer Patient Examination Glove |
| Applicant | INDUSTRIAL CLOTHINGS, LTD. 481 A, PRINCE OF WALES AVE. Columbo 14, LK 14 |
| Contact | Syed Umair Ahmed |
| Correspondent | Syed Umair Ahmed INDUSTRIAL CLOTHINGS, LTD. 481 A, PRINCE OF WALES AVE. Columbo 14, LK 14 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-18 |
| Decision Date | 2000-09-13 |