The following data is part of a premarket notification filed by Industrial Clothings (pvt) Ltd with the FDA for Midas Touch-nitrile Examination Gloves- Powder Free, Orange, Xs, Model Snaeft-240or-xs; Midas Touch-nitrile Examination Gloves -powder Free, Orange, Xxl, Model Snaeft-240or-xxl.
| Device ID | K150414 |
| 510k Number | K150414 |
| Device Name: | Midas Touch-Nitrile Examination Gloves- Powder Free, Orange, XS, Model SNAEFT-240OR-XS; Midas Touch-Nitrile Examination Gloves -Powder Free, Orange, XXL, Model SNAEFT-240OR-XXL |
| Classification | Polymer Patient Examination Glove |
| Applicant | INDUSTRIAL CLOTHINGS (PVT) LTD D17, SEETHAWAKA EXPORT PROCESSING ZONE Avissawella, LK 10700 |
| Contact | S.n. Hari |
| Correspondent | S.n. Hari INDUSTRIAL CLOTHINGS (PVT) LTD D17, SEETHAWAKA EXPORT PROCESSING ZONE Avissawella, 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 | 2015-02-18 |
| Decision Date | 2015-06-12 |