SYNTHETIC (BLUE) VINYL PATIENT EXAMINATION GLOVES - POWDER FREE

{0}------------------------------------------------ ## SEP - 2 2004 #### 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: _ kot 2347 #### 1. Submitter's Identification: Mr. Wang Ying Hai Shijiazhuang Hongxiang Plastics Products Co., Ltd. New High Technologies Industrial Zone Lu Quan City, Hebei Province P.R. China Date Summary Prepared: August 02, 2004 #### 2. Name of the Device: Shijiazhuang Hongxiang Plastics Products Co., Ltd. Synthetic (Blue) Vinyl Patient Examination Gloves-Powder Free #### 3. Predicate Device Information: Shijiazhuang Hongxiang Plastic Products Co., Ltd. Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves (K001834) #### 4. Device Description: Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Vinyl Patient Examination Glove, 80L YZ, and meets all requirements of ASTM Standard D5250-00E4 #### 5. Intended Use: A 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. {1}------------------------------------------------ #### 6. Comparison to Predicate Devices: Shijiazhuang Hongxiang Plastics Products Co., Ltd. Synthetic (Yellow) Vinyl Patient Examination Gloves-Powder Free, is substantially equivalent in safety and effectiveness to the Shijiazhuang Hongxiang Plastic Products Co., Ltd. Synthetic Powder Free (Yellow) Vinyl Patient Examination Gloves. ## 7. Discussion of Non-Clinical tests Performed for Determination of Substantial Equivalence are as follows: The standards used for Shijiazhuang Hongxiang Plastics Products Co., Ltd. glove production are based on ASTM-D-5250-00E4. 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 based on ASTM D-5151-99 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. 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 2 mg powder per glove). ## 8. Discussion of Clinical Tests Performed: Not Applicable - There is no hypoallergenic Claim. ## 9. Conclusions: Shijiazhuang Hongxiang Plastics Co., Ltd. Synthetic (Blue) Vinyl Patient Examination gloves-Powder Free conform fully to ASTM-D-5250-00E4 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 seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is evenly spaced around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # SEP = 2 2004 Shijiazhuang Hongxiang Plastics Products Company Limited C/O Mr. James Chu Official Correspondent Gloveco, Incorporated 590 West Central Avenue, #D Brea, California 92821 Re: K042247 Trade/Device Name: Synthetic (Blue) Vinyl Patient Examination Gloves-Powder Free Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYZ Dated: August 18, 2004 Received: August 19, 2004 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 approvisions 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 - Mr. Chu 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. or the For all any I 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) Prinstet milification. 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), 11 you donto specifican at (301) 594-4618. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Chin Lin, Ph.D. 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}------------------------------------------------ ## Attachment A # INDICATIONS FOR USE 510(k) NUMBER (if KNOWN) :_ K C 43247 Shijiazhuang Hongxiang Plastic Products Co., Ltd. APPLICANT: Synthetic (Blue) Vinyl Patient Examination Glove-Powder Free DEVICE NAME: INDICATIONS FOR USE: A patient examination glove is disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. (21 CFR 880.6250) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter-Use (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) Kain Ruby (Division Sign-C (Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental D 510(k) Number: K 042247