VINYL EXAM GLOVE, POWDER-FREE, NON-STERILE

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the Department of Health and Human Services in the USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. The eagle is facing to the right. ## MAR 1 0 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Zibo Hengchang Plastic & Rubber Products Company Limited C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street NW Buffalo, Minnesota 55313 Re: K042952 Trade/Device Name: Powder-Free Vinyl Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYZ Dated: February 26, 2005 Received: February 28, 2005 Dear Mr. Job: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rowled your and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in moreditorions for also baber to May 28, 1976, the enactment date of the Medical Device Incrisiate commerce prior to thay a been reclassified in accordance with the provisions of Antendinents, of to do rought Act (Act) that do not require approval of a premarket the Federal Food, Drag, and Coou may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of a 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Wri), it may of such of Federal Regulations, Title 21, Parts 800 to 898. In your device ear oc roundsh further announcements concerning your device in the Lederal Register. {1}------------------------------------------------ Page 2 - Mr. Job Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA S Issualles of a substantes with other requirements mean that FDA has made a decemination that your and your receral agencies. of the Act or any Federal statutes and regulations administered by penistration of the Act or any rederal statues and regirements, including, but not limited to: registration You must comply with all the Act 's requirements and manufacturing progrice You must comply with an the Act 3 requirements and 801); good manufacturing practice and listing (21 CFR Part 807); labeling (21 CFR Part 801); gract 800'; and i and listing (21 CFR Fall 807), labeling (21 OFF Craires) / requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin mailer.ing your device of your device to a premarket notification. The FDA miding or substains of as a casification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific auvice for your de at (240) 276-0115. Also, please note the regulation please contact inc Office or Comphanes are (210) = = = = = = = = = = = = = may obtain other general information on your responsibilities under the Act from the may obtain other general miorinational and Consumer Assistance at its toll-free Division (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Ours Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications for Use: A patient examination glove is a disposable device intended for medical purpose that A patient cxaminer's hands or finger to prevent contamination between patient and examiner. Prescription Use __ (Part 21 CFR 801 Subpart 1) AND/OR Over-The-Counter Use X (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Schute M. Chie MD Division Sian-Off Ivision of Anesthesiology, General Hospital, Infection Control, Dental Device 510(k) Number K042752 EXHIBIT B