POWDERED (BLUE) NITRILE PATIENT EXAMINATION GLOVES

{0}------------------------------------------------ # 510(K) SUMMARY 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: _ K 02 ! S06 ## 1. Submitter's Identification: Mr. Chen-Sheng Wei Shijiazhuang Great Vision Plastics Products Co., Ltd. Cangshi S. Road, East District Jinzhou City, Hebei Province P.R. China Date Summary Prepared: May 03, 2002 #### Name of the Device: 2. Shijiazhuang Great Vision Plastics Products Co., Ltd. Powdered (Blue) Nitrile Patient Examination Gloves ## 3. Predicate Device Information: Shanghai Poseidon Plastic Products Co., Ltd. Nitrile Examination Gloves, Pre-Powdered, Color Blue (K001837) #### 4. Device Description: Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250. Powdered Nitrile Patient Examination Glove, 80LZA, and meets all requirements of ASTM Standard D6319-00a1. ## 5. Intended Use: A patient examination glove is a disposable device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment. {1}------------------------------------------------ ## 6. Comparison to Predicate Devices: Shijiazhuang Great Vision Plastics Products Co., Ltd. Powdered (Blue) Nitrile Patient Examination Gloves, is substantially equivalent in safety and effectiveness to the Shanghai Poseidon Plastic Products Co., Ltd. Nitrile Examination Gloves, Pre-Powdered, Color Blue. ## 7. Discussion of Non-Clinical tests Performed for Determination of Substantial Equivalence are as follows: The standards used for Shijiazhuang Great Vision Plastics Products Co., Ltd. glove production are based on ASTM-D-6319-00a1. 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 G-1, 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. There are no special labeling claims and we do not claim our gloves as hypoallergenic on our labels. A Residual Powder Test that based on ASTM D6124-01 for Starch at finished inspection is conducted to insure that our gloves meet our "powder-free' claims (contain no more than 120 mg powder per glove). ## 8. Discussion of Clinical Tests Performed: Not Applicable - There is no hypoallergenic Claim. ## 9. Conclusions: Shijiazhuang Great Vision Plastics Co., Ltd. Powdered (Blue) Nitrile Patient Examination gloves conform fully to ASTM-D-6319-00a1 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. {2}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or movement. #### 6 2002 JUN Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Shijiazhuang Great Vision Plastic Products Company Limited C/O Mr. James Chu Gloveco Incorporated 12390 East End Avenue Chino, California 91710 Re: K021506 Trade/Device Name: Powdered (Blue) Nitrile Patient Examination Gloves Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LZA Dated: May 3, 2002 Received: May 9, 2002 Dear Mr. Chu: 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. 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 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. 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. {3}------------------------------------------------ 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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. Susan Runored Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Attachment A Page 1 of 1 510(k) NUMBER (IF KNOWN): K 02 | 506 Shijiazhuang Great Vision Plastics Products Co., Ltd. DEVICE NAME: INDICATIONS FOR USE: Powdered (Blue) Nitrile Patient Examination Gloves A patient examination glove is disposable device intended for medical a purpose 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 ON ANOTHER PAGE IF NEEDED.) | Concurrent of CDRH, Office of Device Evaluation (ODE) | |-------------------------------------------------------| |-------------------------------------------------------| | Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter-Use (Optional Format 1-2-96) | |---------------------------------------|----|-----------------------------------------------| |---------------------------------------|----|-----------------------------------------------| | (Division Sign-Off) | |---------------------------------------------------------------------| | Division of Dental, Infection Control, and General Hospital Devices | | 510(k) Number | K021506 | |---------------|---------| |---------------|---------|