POWDER FREE NITRILE EXAMINATION GLOVES, BLUE

{0}------------------------------------------------ ## 510(K) SUMMARY MAY 15 2007 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: ___ K070861 ### 1. Submitter's Identification: Mr. Yuchun Jia Hong xin Plastic Products Co., Ltd. Fanjiazhuang Industrial Zone Xinji City, Hebei, China 052360 Date Summary Prepared: December 28, 2006 ### 2. Name of the Device: Hong Xin Rubber Products Co., Ltd. Powder Free Nitrile Examination Gloves, Blue #### 3. Predicate Device Information: Shanghai Poseidon Plastic Products Co., Ltd. Nitrile Exam Gloves, Powder-Free, Color Blue (K001128) #### 4. Device Description: Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Power-Free Nitrile Examination Gloves, Blue, 80 LZA, and meets all requirements of ASTM standard D-6319-00a (2005). ### 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: Hong Xin Rubber Products Co., Ltd.'s Powder Free Nitrile Examination Gloves, Blue, is substantially equivalent in safety and effectiveness to the Shanghai Poseidon Plastic Products Co., Ltd.'s Nitrile Exam Gloves, Powder-Free, Color Blue. # 7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as Follows: The standards used for Hong Xin Rubber Products Co., Ltd.'s glove production are based on ASTM-D-6319-00a 2005). 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. A Residual Powder Test that based on ASTM D-6124-06 for Starch 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: Hong Xin Rubber Products Co., Ltd.'s Powder Free Nitrile Examination Gloves, Blue conform fully to ASTM-D-6319-00a (2005) 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}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with outstretched wings, rendered in a simple, graphic style. ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850 Hong Xin Rubber Products Company Limited C/O Ms. Kathy Liu Official Correspondent Gloveco Incorporated 3973 Schafer Avenue Chino, California 91710 MAY 15 2007 Re: K070861 Trade/Device Name: Power Free Nitrile Examination Gloves, Blue Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: December 28, 2006 Received: March 28, 2007 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. 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. {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); 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 you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276- 0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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, Signature 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 {4}------------------------------------------------ Page 1 of 1 ## INDICATION FOR USE 510(K) NUMBER (IF KNOWN): APPLICANT: DEVICE NAME: K070861 Hong Xin Rubber Products Co., Ltd. Powder Free Nitrile Examination Gloves, Blue ### INDICATIONS FOR USE: 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. Prescription Use (Per 21 CFR 801.109) OR (K) Number __ Over-The-Counter-Use V (Optional Format 1-2-96) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.) concurrent of CDRH, Office of Device Evaluation (ODE) K070861 sign-Off) ion of Anesthesiology, General Hospital, suon Control, Dental Devices