Data / Medical devices / Sri Lanka / Midas Safety Lanka (private) Limited
Midas Safety Lanka (private) Limited: FDA-registered device maker in AVISSAWELLA Western, Sri Lanka, 12 510(k) clearances
Midas Safety Lanka (private) Limited is registered with the FDA (registration 9613494) in AVISSAWELLA Western, Sri Lanka. It lists 2 device types. The FDA files 12 510(k) clearances under its listings, the newest dated June 12, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9613494
- FEI number
- 3012355534
- Address
- Prime Polymers Division D 17, Seethawaka Export Processing Zone, AVISSAWELLA Western, Sri Lanka, 10700
- Owner or operator
- MIDAS SAFETY LANKA (PVT) LTD. (9038698)
- Roles
- Manufacturer
- First device listed
- December 7, 2007
- Registered through
- 2026
- Brand names listed
- Midas Touch, Midas Touch¿, SHELBY GROUP INTL., INC.
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Latex Patient Examination Glove | LYY | 1 | Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 12, 2015 | K150414 | 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 | LZA | Substantially Equivalent | Industrial Clothings (Pvt), Ltd. | accessdata.fda.gov |
| August 8, 2013 | K130846 | MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN | LZA | Substantially Equivalent | Industrial Clothings, Ltd. | accessdata.fda.gov |
| April 12, 2013 | K122464 | MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, ORANGE | LZA | Substantially Equivalent | Industrial Clothings, Ltd. | accessdata.fda.gov |
| April 5, 2013 | K122453 | MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, GREY | LZA | Substantially Equivalent | Industrial Clothings, Ltd. | accessdata.fda.gov |
| October 16, 2012 | K122465 | MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, PINK | LZA | Substantially Equivalent | Industrial Clothings, Ltd. | accessdata.fda.gov |
| March 9, 2004 | K033496 | MIDAS TOUCH BLUE LATEX EXAMINATION GLOVES - POWDER FREE FOR CHEMOTHERAPY USE | LYY | Substantially Equivalent | Industrial Clothings, Ltd. | accessdata.fda.gov |
| November 12, 2002 | K023159 | MIDAS TOUCH BLUE LATEX EXAMINATION GLOVES - POEDER FREE | LYY | Substantially Equivalent | Industrial Clothings, Ltd. | accessdata.fda.gov |
| October 8, 2002 | K022781 | MIDAS TOUCH PURPLE NITRILE EXAMINATION GLOVES-POLYMER COATED, POWDER FREE | LZA | Substantially Equivalent | Industrial Clothings, Ltd. | accessdata.fda.gov |
| May 22, 2002 | K021465 | MIDAS TOUCH LATEX EXAMINATION GLOVES-POLYMER COATED, POWDER FREE | LYY | Substantially Equivalent | Industrial Clothings, Ltd. | accessdata.fda.gov |
| September 13, 2000 | K000145 | MIDAS TOUCH BLUE NITRILE EXAMINATION GLOVES-POWDER FREE | LZA | Substantially Equivalent | Industrial Clothings, Ltd. | accessdata.fda.gov |
| September 13, 2000 | K000142 | MIDAS TOUCH LATEX EXAMINATION GLOVES-POWDER FREE | LYY | Substantially Equivalent | Industrial Clothings, Ltd. | accessdata.fda.gov |
| September 13, 2000 | K000138 | MIDAS TOUCH NITRILE EXAMINATION GLOVES-POWDERFREE | LZA | Substantially Equivalent | Industrial Clothings, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated June 12, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.