POWDER FREE NITRILE EXAMINATION GLOVE-BLUE (CHEMOTHERAPY)

{0}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES 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. In the center of the circle is an abstract symbol that resembles a bird or a stylized human figure. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002 Matang Manufacturing Sdn. Bhd Ms. Leslie Leong Operation Manager Lot 10, Kawasan Perindustrian Serkam Mukim Serkam, Merlimau Melaka, Malaysia 77300 OCT 1 7 2012 Re: K122131 Trade/Device Name: Powder Free Nitrile Examination Glove -- Blue (Chemotherapy). Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA, LZC Dated: October 4, 2012 Received: October 12, 2012 Dear Ms. Leong: 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 to 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 you, 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- Ms. Leong 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 (21 CFR Part 801); medical device reporting (reporting of medical device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportaProblem/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. Sincerely yours, Antheon D. anaton Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Premarket Notification For Powder Free Nitrile Examination Glove - Blue (Chemotherapy) | <b>3.0</b> | <b>Indication For Use Statement</b> | |------------|-------------------------------------| |------------|-------------------------------------| 510(K) Number (if known): K122131 Device Name : Powder Free Nitrile Examination Glove - Blue (Chemotherapy) : A Powder Free Nitrile Examination Glove - Blue Indications For Use (Chemotherapy) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between the patient and examiner. In addition, these Chemotherapy gloves were tested for use with the following drug concentrations per ASTM D 6978-05 Permeation Test Results | TEST CHEMOTHERAPY DRUG AND<br>CONCENTRATION | MINIMUM BREAKTHROUGH<br>DETECTION TIME (Specimen<br>1/2/3)(Minutes) | |----------------------------------------------------|---------------------------------------------------------------------| | Carmustine (BCNU), 3.3 mg/ml (3,300 ppm) | 60.3<br>(60.3, 60.5, 60.6) | | Cisplatin, 1.0 mg/ml (1,000 ppm) | No breakthrough up to 240 min. | | Cyclophosphamide (Cytoxan), 20.0 mg/ml (20,000ppm) | No breakthrough up to 240 min. | | Dacarbazine (DTIC), 10.0 mg/ml (10,000 ppm) | No breakthrough up to 240 min. | | Doxorubicin Hydrochloride, 2.0 mg/ml (2,000 ppm) | No breakthrough up to 240 min. | | Etoposide (Toposar), 20.0 mg/ml (20,000 ppm) | No breakthrough up to 240 min. | | Fluorouracil, 50.0 mg/ml (50,000 ppm) | No breakthrough up to 240 min. | | Ifosfamide, 50.0 mg/ml (50,000 ppm) | No breakthrough up to 240 min. | | Methotrexate, 25 mg/ml (25,000 ppm) | No breakthrough up to 240 min. | | Mitomycin C, 0.5 mg/ml (500 ppm) | No breakthrough up to 240 min. | | Mitoxantrone, 2 mg/ml (2,000 ppm) | No breakthrough up to 240 min. | | Paclitaxel (Taxol), 6.0 mg/ml (6,000 ppm) | No breakthrough up to 240 min. | | Thiotepa, 10.0 mg/ml (10,000 ppm) | 156.0<br>(163.8, 156.0, 165.0) | | Vincristine Sulfate, 1.0 mg/ml (1,000 ppm) | No breakthrough up to 240 min. | Caution : Testing showed the following drugs have low average breakthrough detection time: * Carmustine - 60.3 min * Thiotepa - 156.0 min Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use AND/OR (21 CFR 801 Subpart C) ter Use √ (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) División Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 3 **510(k) Number:** K 12213