POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES, POLYMER COATED ON OUTSIDE AND NITRILE COATED ON INSIDE, BLUE COLOR WITH

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL - 9 2001 K. Karunakaran Mr. Quality Assurance Manager PWA Industries Sdn. Bhd. Lot 93, Kawasan Perindustrain Semambu 25350 Kuantan, Pahang, MALAYSIA Re : K011895 Trade/Device Name: Powder-Free Multi-Ply Latex Examination Gloves, Polymer Coated on Outside and Nitrile Coated Inside, Blue Color with Protein Labeling Claim 50 Micrograms or Less of Total Extractable Protein Regulation Number: 880.6250 Regulatory Class: I Product Code: LYY Dated: June 14, 2001 Received: June 18, 2001 Dear Mr. Karunakaran: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 acvices chare federal Food, Drug, and Cosmetic Act (Act). 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. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major be bublede to back addroundevice can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ಗ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug {1}------------------------------------------------ Page 2 - Mr. Karunakaran Administration (FDA) will verify such assumptions. Failure to Admiliberation (CMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: concerning your device in arranket notification submission does chis response or four for you might have under sections 531 not arrough 542 of the Act for devices under the Electronic emoduct Radiation Control provisions, or other Federal laws or requlations. This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA described in your sia equivalence of your device to a legally rinding of bubbandar of results in a classification for your markets produce, permits your device to proceed to the market. If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in ritro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html". Sincerely yours, Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## INDICATION FOR USE Applicant: PWA INDUSTRIES SDN.BHD. 510(k) Number (if known): -------------------------------------------------------------------------------------------------------------------------- DEVICE NAME: Powder-free Multi-ply Latex Examination Gloves, Polymer Coated on the Outside and Nitrile Coated on the Inside (Blue Color). With Protein Labeling claim 50ug/g or less of total extractable protein content. ## INDICATIONS FOR USE: A patient examination gloves is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use--------------------------(Per 21 CFR 801.109) OR Over The Counter Use -- (Optional Format 1-2-95) Clins. Lin (Division Sign-Off) Division of Dental, Infection Cor and General Hospit 510/k) Number