The following data is part of a premarket notification filed by Industrial Clothings, Ltd. with the FDA for Midas Touch, Nitrile Examination Gloves, Powder-free, Pink.
| Device ID | K122465 |
| 510k Number | K122465 |
| Device Name: | MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, PINK |
| Classification | Polymer Patient Examination Glove |
| Applicant | INDUSTRIAL CLOTHINGS, LTD. D 17, SEETHAWAKA EXPORT PROCESSING ZONE Auissawella, LK 10700 |
| Contact | S.n. Hari |
| Correspondent | S.n. Hari INDUSTRIAL CLOTHINGS, LTD. D 17, SEETHAWAKA EXPORT PROCESSING ZONE Auissawella, LK 10700 |
| Product Code | LZA |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-13 |
| Decision Date | 2012-10-16 |