POWDER FREE VINYL PATIENT EXAMINATION GLOVES, LIGHT YELLOW COLOR

{0}------------------------------------------------ # Section C 510(k) Summary (21 CFR 807.92) ## JUN 1 6 2011 # 510(K) Summary "This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92." 11450 " (applicant leave blank) "The assigned 510(k) number is: Premarket Notification [510(k)] Summary [(a)(1)]. The summary contains on the first page, preferably on your letterhead paper, the submitter's name, address, phone and fax numbers, name of contact person, and date the summary was prepared : Submitter's name : JIANGSU ALFA GLOVE CO., LTD 10 District A, Standard Factory, The Economic Submitter's address : Development Zone, Suqian, Jiangsu, 223800, China 86-527-88286055 Phone number : 86-527-88286000 Fax number : Name of contact person: Mr.ChenFeng Zhang May 10, 2011 Date the summary was prepared: [(a)(2)]. The name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known_ Device Name: Powdered Free Vinyl Patient Examination Gloves, Light Yellow Color Proprietary/Trade name: Powdered Free Vinyl Patient Examination Gloves, Light Yellow Color Other clients private labeling Common Name: Classification Name: Device Classification: Regulation Number: Panel: Product Code: Exam gloves Patient examination glove 1 21 CFR 880.6250 General Hospital (80) LYZ [(a)(3)]. An identification of the legally marketed device to which your firm is claiming substantial equivalence . Class 1* Powdered Free Vinyl Patient Examination Gloves, Light Yellow Color that meets all of the requirements of ASTM standard D 5250-06e1. Section C 1411 {1}------------------------------------------------ #### [(a)(4)] A description of the device Device Description: Powdered Free Vinyl Patient Examination Gloves, Light Yellow Color that meets all of the requirements of ASTM standard D 5250-06e1. #### [(a)(5)] The summary describes the intended use of the device Device Intended Use: Powdered Free Vinyl Patient Examination Gloves, Light Yellow Color 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. ### [(a)(6)] A summary of the technological characteristics of new device compared to the predicate device. The Powdered Free Vinyl Patient Examination Gloves, Light Yellow Color, non sterile are summarized with the following technological characteristics compared to ASTM or equivalent standard. | Characteristics | Standard | Device performance | |-----------------------|------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------| | Dimension | ASTM standard D 5250-06 e1. | Meets | | Physical Properties | ASTM standard D 5250-06 e1. | Meets | | Freedom from pinholes | 21 CFR 800.20 | Meets | | Powder Residual | ASTM standard D 5250-06 e1<br>and D6124-06 | <2mg/glove | | Biocompatability | Primary Skin Irritation in rabbits<br>AAMI / ANSI / ISO 10993-10<br>Dermal sensitization in the guinea pig<br>AAMI / ANSI / ISO 10993-10 | Passes<br>Not a Primary Skin Irritation<br>Passes<br>Not a Dermal sensitization | #### [(b)(1)] A brief discussion of the nonclinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence . Powdered Free Vinyl Patient Examination Gloves, Light Yellow Color, meet requirements per ASTM D5250-06 el, per ASTM D6124-06, per 21 CFR 800.20 and FDA recognition number 2-152; AAMI / ANSI / ISO 10993-10:2002/Amd. 1:2006. ### [(b)(2)] A brief discussion of the clinical submitted, reference, or relied on in the premarket notification submission for a determination of substantial equivalence . Clinical data is not needed for gloves or for most devices cleared by the 510(k) process. #### [(b)(3)] The conclusions drawn from the nonclinical tests that demonstrate that the device is as safe,as effective, and performed as well or better than the legally marketed device identified in (a)(3). It can be concluded that the Powdered Free Vinyl Patient Examination Gloves, Light Yellow Color meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims. It can be concluded that the Powdered Free Vinyl Patient Examination Gloves, Light Yellow Color is as safe, as effective, and performs as well as the predicate device, Powder-Free Vinyl Patient Examination Gloves, Clear (Non-colored), ZHANG JIA GANG FENGYUAN PLASTIC PRODUCTS CO LTD.K091663. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of what appears to be a caduceus, a symbol often associated with healthcare, featuring a staff with a snake winding around it. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002 Jiangsu Alfa Glove Company, Limited C/O Mr. Chu Xiaoan Beijing Easy-Link Company, Limited Room 1606 Building 1. Jianxiang Yuan No. 209, Beisi Huan Zhong Road Hai Dian District, Beijing China 100083 JUN 1 6 2011 Re: K111459 Trade/Device Name: Powdered Free Vinyl Patient Examination Gloves, Light Yellow Color Regulation Number: 21 CFR 880.6250 Regulation Name: Regulatory Class: I Product Code: LYZ Dated: May 18, 2011 Received: May 26, 2011 Dear Mr. Xiaoan: 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. {3}------------------------------------------------ Page 2- Mr. Xiaoan 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 (OS) 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 /ucm 115809.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 vours. Anthony D. Watson 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 {4}------------------------------------------------ #### Section B Indications for Use #### INDICATIONS FOR USE JIANGSU ALFA GLOVE CO., LTD Applicant: 510(k) Number (if known): * Powdered Free Vinyl Patient Examination Gloves, Light Yellow Color Device Name: Indications For Use: Powdered Free Vinyl Patient Examination Gloves, Light Yellow Color is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use × (21 CFR 801 Subpart C) (Please do Not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Elaine S. Marshall Division Sign-Off) oth Claver re-willians bar Eliza "vision of Anesthesiology, General Hospital rection Control, Dental Devices 111459 :10(k) Number: