POWDER FREE NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVES WITH LABELING PROTEIN CONTENT CLAIM (50 MICROGRAMS OR LESS)

{0}------------------------------------------------ ## JAN 2 8 2005 ## 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. Image /page/0/Picture/4 description: The image shows the text "The assigned 510(k) number is:" followed by the number "K043014". The number appears to be handwritten. The text is black and the background is white. ### 1. Submitter's Identification: Mr. Yang Ying Shijiazhuang Tillotson Rubber Products Co., Ltd. Donggao Industrial Zone Zanhuang, Hebei Province P.R. China Date Summary Prepared: October 06, 2004 #### 2. Name of the Device: Shijiazhuang Tillotson Rubber Products Co., Ltd. Powder Free Natural Rubber Latex Patient Examination Gloves with a Protein Labeling Claim (50 micrograms or less) and Made from Allotex® an Enzyme Treated Natural Rubber Latex #### 3. Predicate Device Information: Syntex Healthcare Products Co., Ltd. Powder Free Latex Examination Glove with Protein Labeling Claim (50 micrograms or less) (K021059) #### 4. Device Description: Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Patient Examination Glove, 80LYY, and meets all requirements of ASTM Standard D 3578-01aE2. #### 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 Tillotson Rubber Products Co., Ltd. Powder Free Natural Rubber Latex Patient Examination Gloves with a Protein Labeling Claim (50 micrograms or less) and Made from Allotex® an Enzyme Treated Natural Rubber Latex is substantially equivalent in safety and effectiveness to the Syntex Healthcare Products Co., Ltd. Powder Free Latex Examination Glove with Protein Labeling Claim (50 micrograms or less). ## 7. Discussion of Non-Clinical tests Performed for Determination of Substantial Equivalence are as follows: The standards used for Shijiazhuang Tillotson Rubber Products Co., Ltd. glove production are based on ASTM D 3578-01aE2. All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AQL 4.0. The "Maximum Fill" 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 2 mg powder per glove). ## 8. Discussion of Clinical Tests Performed: Not Applicable - There is no hypoallergenic Claim. ## 9. Conclusions: . Shijiazhuang Tillotson Rubber Products Co., Ltd. Powder Free Natural Rubber Latex Patient Examination Gloves with a Protein Labeling Claim (50 micrograms or less) and Made from Allotex® an Enzyme Treated Natural Rubber Latex conform fully to ASTM D 3578-01aE2 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 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 emblem featuring a symbol of three horizontal lines that curve and flow together, resembling a stylized human form or a wave-like design. JAN 2 8 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Shijiazhuang Tillotson Rubber Products Company Limited C/O Mr. James Chu Official Correspondent Gloveco, Incorporated 590 West Central Avenue, #D Suite Brea, California 92821 Re: K043014 Trade/Device Name: Powder Free Natural Rubber Low Modulus Latex Patient Examination Gloves with a Protein Labeling Claim (50 Micrograms or Less) and made from Allotex an Enzyme Treated Natural Rubber Latex Regulation Number: 880. 6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LYY Dated: December 21, 2004 Received: January 12, 2005 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 appear and 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 (1 Mr.), I had in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Ecderal Register. {3}------------------------------------------------ Page 2 – Mr. Chu Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DTS Issualled of a bases and inst your device complies with other requirements If the Act or any Federal statutes and regulations administered by other Federal agencies. of the ACI of ally I edelar statutes and regisments, including, but not limited to: registration You must comply with an the Fice b rog (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Part 007), absitisg (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality byovisions (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) This letter will anow you to objact to and the substantial equivalence of your device to a premarket notification. - The PDF Intellis 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), If you desire specific advice to: Join as 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 may obtain 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/industry/support/index.html. Sincerely yours, 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}------------------------------------------------ # Indications for Use 510(k) Number (if known): K043014 Device Name: Powder Free Natural Rubber Low Modulus Latex Patient Examination Gloves with a Protein Labeling Claim (50 micrograms or less) and Made from Allotex an Enzyme Treated Natural Rubber Latex Indications For Use: A patient examination glove is 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) signature Civision Sign-Off) Olvision of Anesthesiology, General Hospital, Intection Control, Dental De 510(k) Number: K043014