POWDER FREE VINYL PATIENT EXAMINATION GLOVES

{0}------------------------------------------------ ## 510(K) SUMMARY # NOV - 3 2010 This summary of 510(K) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR §807.92. The assigned 510(K) number is: K102093 # l . Owner's Identification: Mr. Jianping Wang Shijiazhuang Great Vision Plastic Products Co., Ltd. Cangshi South Rd., East Dist. Jinzhou City, Hebei Province, CHINA 052260 Tel: 86-311-83980207 Submitter: Kathy Liu Address: 3973 Schaefer Ave, Chino, California 91710 Tel: 909-590-1611 Date Summary Prepared: October 18, 2010 ### 2. Name of the Device: Shijiazhuang Great Vision Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Gloves ### 3. Predicate Device Information: Better Care Plastic Products Co., Ltd Powder Free Vinyl Patient Examination Glove (K092296) ### 4. Device Description: Classified by FDA's General Hospital and Personal Use Device panel as Class I, 21 CFR 880.6250, Power Free Vinyl Patient Examination Glove, 80 LYZ, and meets all requirements of ASTM standard D-5250-06e1. ### 5. Intended Use: A patient examination glove is disposable non-sterile device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. # 6. Comparison to Predicate Devices: Shijiazhuang Great Vision Plastic Products Co., Ltd.'s Powder Free Vinyl Patient Examination Gloves is substantially equivalent in safety and effectiveness to the Better Care Plastic Products Co., Ltd's Powder Free Vinyl Patient Examination Glove (K092296). {1}------------------------------------------------ EXHIBIT #1 Page 2 of 2 K102093 # 7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as Follows: The standards used for Shijiazhuang Great Vision Plastic Products Co., Ltd.'s glove production are based on ASTM D-5250-06e1. All testing meets requirements for physical and dimensions testing conducted on gloves. Inspection level S-2, AQL 4.0. The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, inspection level I, meeting these requirements. Primary Skin Irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions. A Residual Powder Test that based on ASTM D-6124-06 for powder at finished inspection is conducted to insure that our gloves meet our "powder-free" claims (contain no more than 2 mg powder per glove). #### 8. Labeling: There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels. ### 9. Discussion of Clinical Tests Performed: Not Applicable - There is no hypoallergenic Claim. ### 10. Conclusions: Shijiazhuang Great Vision Plastic Products Co., Ltd.'s Powder Free Vinyl Patient Examination Gloves conform fully to ASTM D-5250-06e1 standard as well as applicable 21 CFR references, and meets pinhole FDA requirements, biocompatibility requirements and labeling claims as shown by data in Section 7. There are no safety/efficacy issues or new claims from the "substantial equivalence" products cited. The device herein mentioned is as safe, as effective, and performs as well as or better than the predicate device. . {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Shijiazhuang Great Vision Plastic Products Company, Limited C/O Ms. Kathy Liu Official Correspondent Surprotect, Incorporated 3973 Schaefer Avenue Chino, California 91710 NOV - 3 2010 Re: K102093 Trade/Device Name: Powder Free Vinyl Patient Examination Gloves Regulation Number: 21 CFR 880,6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: October 20, 2010 Received: October 22, 2010 Dear Ms. Liu: 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- Ms. Liu 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/ResourcesforYou/Industry/default.htm. Sincerely yours, Jum. J. S. S. S. for 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}------------------------------------------------ Attachment A # INDICATION FOR USE NOV - 3 2010 | 510 (k) NUMBER (IF KNOW): | | |---------------------------|---| | APPLICANT: | S | | DEVICE NAME: | P | K102093 hijiazhuang Great Vision Plastic Products Co., Ltd. Powder Free Vinyl Patient Examination Gloves # INDICATIONS FOR USE: A patient examination glove is disposable non-sterile device intended for medical purpose 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 _ (21CFR 801Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.) | | Concurrent of CDRH, Office of Device Evaluation (ODE) | |--|-------------------------------------------------------| |--|-------------------------------------------------------| Division Sign-Off) Division of Anesthesiology, General Hospital infection Control, Dental Devices 510(k) Number: K102093