POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)

{0}------------------------------------------------ # 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." "The assigned 510(k) number is: K 090691 (applicant leave blank) MAY 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 : | SHIJIAZHUANG BENESTAR PLASTIC CO., | | |--------------------------------|------------------------------------|--| | | LTD. | | | Submitter's address : | HELI, NANNIU TOWN, ZHENGDING | | | | COUNTY, HEBEI, 050000, CHINA | | | Phone number : | (86) 311-83985366 | | | Fax number : | (86) 311-83986358 | | | Name of contact person: | Mr. David QU | | | Date the summary was prepared: | Mar. 3rd, 2009 | | [(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: | Powder Free Vinyl Patient Examination Gloves, Clear(non-colored) | | |-------------------------|--------------------------------------------------------------------------------|--| | Proprietary/Trade name: | Powder Free Vinyl Patient Examination Gloves<br>Other clients private labeling | | | Common Name: | Patient examination glove | | | Classification Name: | Patient examination glove | | | Device Classification: | I | | | Regulation Number: | 21 CFR 880.6250 | | | Panel: | General Hospital (80) | | | Product Code: | LYZ | | # [(a)(3)]. An identification of the legally marketed device to which your firm is claiming substantial equivalence . Class I* powder free vinyl patient examination gloves , Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06. Predicate device : FUGUAN (Brand). Powder-Free Vinyl Patient Examination Gloves, Shijiazhuang Fuguan Plastic Products Co., Ltd.. K032908 . [(a)(4)] A description of the device {1}------------------------------------------------ Device Description : powder free vinyl patient examination gloves, Clear(non-colored) that meets all of the requirements of ASTM standard D 5250-06. #### {(a)(5)} The summary describes the intended use of the device Device Intended Use: powder free vinyl patient examination glove, Clear(non-colored) 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. ### J(a)(6)} A summary of the technological characteristics of new device compared to the predicate device. The powder free vinyl patient examination gloves, 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 | Meets | | Physical Properties | ASTM standard D 5250-06 | Meets | | Freedom from pinholes | 21 CFR 800.20 | Meets | | Powder Residual | ASTM standard D 5250-06<br>and D6124-01 | <2mg/glove | | Biocompatability | Primary Skin Irritation in rabbits | Passes<br>Not a Primary Skin Irritation | | | Dermal sensitization in the guinea pig | 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 . Powder free vinyl patient examination gloves . Clear(non-colored) meet requirements per ASTM D5250-06, per ASTM D6124-01, per 21 CFR 800.20 and ISO10993-10. ## [(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 Powder Free Vinyl Patient Examination Gloves meet the ASTM standard or equivalent standard and FDA requirements for waterleak test on pinhole AQL., meet labeling claims . {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" encircles the eagle, indicating the department's name and national affiliation. MAY - 7 2009 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Chu Xiaoan Official Correspondent Shijiazhuang Benestar Plastic Company, Limited Room 1606 Bulding, 1. Jianxiang Yuan No. 209 Bei Si Huan Zhong Road, Haidian District, Beijing 100083, P.R. China Re: K090691 Trade/Device Name: Poder Free Vinyl Patient Examination Gloves, Clear (Non-Colored) Regulation Number: 880.6250 Regulatory Class: I Product Code: LYZ Dated: March 3, 2009 Received: March 16, 2009 Dear Mr. Xiaoan: We have reviewed your Scetion 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 be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics 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 (Scctions 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ Page 2- Mr. Xiaoan If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0100. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Susan Runner Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health ## Enclosure {4}------------------------------------------------ # INDICATIONS FOR USE Applicant: SHIJIAZHUANG BENESTAR PLASTIC CO., LTD. 510(k) Number (if known): * Device Name: Powder Free Vinyl Patient Examination Gloves, Clear(Non-colored) Indications For Use: Powder free vinyl patient examination glove 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. 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) Shule Mighy R (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K090691