MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines. Public Health Service Food and Drug Administration 0903 New Hampshire Avenue ocument Control Center - WO66-G60 Silver Spring, MD 20993-0002 August 08, 2013 Industrial Clothings, Limited C/O Mr. S.N. Hari Deputy General Manager Prime Polymers Division D-17 Secthawaka Export Processing Zone Avissawella, Western Province Sri Lanka 10700 Re: K130846 Trade/Device Name: Midas Touch 191 - Nitrile Examination Gloves - Powder Free. Green Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: July 8, 2013 Received: July 10, 2013 Dear Mr. Hari: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. or 10 devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind vou, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Page 2 - Mr. S.N. Hari Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (2 i CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) {21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID Sincerely vours. FOR Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for "MIDAS SAFETY INNOVATIVE SAFETY SOLUTIONS". The logo features a stylized hand on the left, followed by the word "MIDAS" in large, bold letters. Below "MIDAS" is the word "SAFETY" in smaller letters, and below that is the phrase "INNOVATIVE SAFETY SOLUTIONS". ## Industrial Clothings Limited (Prime Polymers Division) 510(k) Submission for Green Nitrile Examination Gloves - Powder free ## INDICATIONS FOR USE | Applicant | : Industrial Clothings Ltd., Prime Polymers Division | |--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) number (if known) | : K130846 | | Device name | : Midas TouchTM - Nitrile Examination Gloves -<br>Powder free, Green | | Indications for use | : A powder-free examination glove is a disposable<br>device intended for medical purposes, that is worn on<br>the examiner's hand or finger to prevent<br>contamination between patient and examiner.<br>Gloves are available with finger textured surface in<br>four sizes; Small, Medium, Large and X-large. | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use _ AND/OR (21 CFR 801 Subpart C) Concurrence of CDRH, Office of Device Evaluation (ODE) Sreekanth Gutala -S 2013.08.05 13:07:18 -04'00' | (Division Sign-Off) | |----------------------------------------------| | Division of Anesthesiology, General Hospital | | Infection Control, Dental Devices | 510(k) Number:________________________________________________________________________________________________________________________________________________________________ - . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-1 | P a g e GRNPF