HG Pro Nitrile Powder Free Examination Gloves

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure, with three overlapping profiles suggesting a sense of community and support. The profiles are connected to three flowing ribbons. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 4, 2016 Healthy Glove Co., Ltd. Teoh Shee Managing Director 119 Kanchanavanich Road, Tambol Patong Hat Yai, Songkhla 90230 THIALAND Re: K152479 Trade/Device Name: HG PRO® Nitrile Powder Free Examination Gloves Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: January 15, 2016 Received: March 7, 2016 Dear Mr. Shee: 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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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, *Tejashri Purohit-Sheth, M.D.* Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use 510(k) Number (if known) K152479 Device Name HG PRO® Nitrile Powder Free Examination Gloves Indications for Use (Describe) A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------|---------------------------------------------------------------------------------| | <input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov *"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."* {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows a logo for the "SRITONG GROUP". The logo consists of two overlapping shapes: a pink circle on the left and a white hexagon on the right. Inside the pink circle are horizontal lines, and inside the hexagon are the letters "HG" in blue. The text "SRITONG GROUP" is written in blue below the logo. # ongkhla 90230, Thailand Tel: +66 74 536815 Fax: +66 74 ## 510(k) SUMMARY HG PRO® Nitrile Powder Free Examination Gloves #### 1.0 Submitter: | Applicant: | Healthy Glove Co., Ltd | | |-------------------------|----------------------------------------|--| | | 119 Kanchanavanich Road, Tambol Patong | | | | Hat Yai, Songkhla 90230 | | | | Thailand | | | Phone Number: | +66 74 536 815 | | | Fax Number: | +66 74 536 816 | | | Name of Contact Person: | Teoh, Choh Shee | | | Preparation date: | January 15, 2016 | | #### 2.0 Name of Device: | Trade/Proprietary Name(s): | HG PRO® Nitrile Powder Free Examination Gloves | |----------------------------|---------------------------------------------------------------| | Common Name: | Patient Examination Glove | | Classification Name: | Patient Examination Gloves (21 CFR 880.6250 product code LZA) | | Device Class: | | ### 3.0 Identification of The Legally Marketed Devices that equivalency is claimed | Device Name: | MEDTEXX™ Blue Colour Powder Free Nitrile Rubber Examination<br>Glove | |-------------------|----------------------------------------------------------------------| | Manufacturer: | Latexx Manufacturing Sdn., Bhd | | 510(k): | K022548 | | MDL: | - | | Regulatory Class: | I | | Product Code: | LZA | #### 4.0 Description of the Device: HG PRO® Nitrile Powder Free Examination Gloves are substantially equivalent to the Class 1 patient examination gloves bearing the product code Nitrile - LZA (21CFR 880.6250). They meet all the current specifications listed under the ASTM Specification D 6319 -10, Standard Specification for {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a logo for the "SRITONG GROUP". The logo consists of two pink circles, one containing horizontal lines and the other containing the letters "HG" in blue inside of a white hexagon. The text "SRITONG GROUP" is written in blue below the logo. Nitrile Examination Gloves for Medical Application. They are made from acrylonitrile-butadiene copolymer dispersion. These gloves are blue in color and are powder free. #### 5.0 Intended Use of the Device: A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. #### 6.0 Summary of Technological Characteristics Compared to the Predicate Device: There are no different technological characteristics of the Subject Device compared to the Predicate Device. HG PRO® Nitrile Powder Free Examination Gloves are summarized with the following technological characteristics compared to ASTM D 6319 or equivalent standards as shown in Table 1. | Characteristics | Reference/Standards | Predicate: K022548<br>Non-Sterile, Powder Free Nitrile<br>Examination glove | Subject Device:<br>New 510(k) submission<br>Non-Sterile, Powder Free Nitrile<br>Examination glove | |------------------------------|--------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer(s) | | Latexx Manufacturing Sdn., Bhd. | Healthy Glove Co., Ltd | | Indication for Use | Medical Gloves Guidance<br>Manual | A patient examination glove is a<br>disposable device intended for<br>medical purposes that is worn<br>on the examiner's hand to<br>prevent contamination between<br>patient and examiner | A patient examination glove is a<br>disposable device intended for<br>medical purposes that is worn on<br>the examiner's hand to prevent<br>contamination between patient<br>and examiner | | Material | ASTM D6319-10 | Nitrile Synthetic Rubber | Nitrile Synthetic Rubber | | Color | - | Blue | Blue | | Texture | - | Textured Fingers | Textured Fingers | | Size | Medical Glove Guidance<br>Manual-Labeling- Issued<br>on January 22, 2008 | Extra Small<br>Small<br>Medium<br>Large<br>Extra Large | Extra Small<br>Small<br>Medium<br>Large<br>Extra Large | | Single Use | Medical Gloves Guidance<br>Manual -Issued on<br>January 22, 2008 | Single use | Single use | | Characteristics | Acceptance<br>Criteria/Standards | Predicate: K022548<br>Non-Sterile, Powder Free<br>Nitrile Examination glove | Subject Device:<br>New 510(k) submission<br>Non-Sterile, Powder Free<br>Nitrile Examination glove | | Dimension | ASTM D6319-10 | Meets ASTM D6319-10 | Meets ASTM D6319-10 | | | | | Length | | | | | Extra Small = 220 mm minimum<br>Small = 220 mm minimum<br>Medium = 230 mm minimum<br>Large = 230 mm minimum<br>Extra Large = 230 mm<br>minimum | | | | | Palm Width | | | | | Extra Small = 60-80 mm<br>Small = 70-90 mm<br>Medium = 85-105 mm<br>Large = 100-120 mm<br>Extra Large = 110-130 mm | | | | | | | Thickness | ASTM D6319-10 | Meets ASTM D6319-10 | Meets ASTM D6319-10 | | | | | Finger: 0.05 mm min | | | | | Palm: 0.05 mm min | | Physical<br>Properties | ASTM D6319-10 | Meet ASTM D6319-10 | Meet ASTM D6319-10 | | | | | Tensile Strength: | | | | | 14 MPa min (before aging) | | | | | 14 MPa min (after aging) | | | | | Ultimate Elongation: | | | | | 500% min (before aging) | | | | | 400% min (after aging) | | Watertight test<br>(1000 ml) | ASTM D5151-06 | Pass | Pass AQL 1.5 | | Residual Powder | ASTM D6124-06 | Meet<br>≤ 2.0 mg/glove | Meet<br>≤ 2.0 mg/glove | | Biocompatibility | Primary Skin Irritation - ISO<br>10993-10: 2010 | Pass | Pass | | | | | Not a primary skin irritant<br>under the conditions of the<br>study | | | | | | | | Dermal Sensitization - ISO<br>10993-10: 2010 | Pass | Not a contact sensitizer under<br>the conditions of the study | #### Table 1. Side-by-Side Comparison of Predicate Device with Subject Device: Indication for Use, Non-clinical Performance Data and Technological Characteristics {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows a logo for the "SRITONG GROUP". The logo consists of two pink circles that are connected. The left circle contains horizontal lines, and the right circle contains the letters "HG" in blue. The text "SRITONG GROUP" is located below the logo. HEALTHY GLOVE CO., LTD., LTD. 119 Kanchanavanich Road, T. Patong, Hatyai, Songkhla 90230, Thailand Tel: +66 74 536815 Fax: +6 74 536 816 {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows a logo for the "SRITONG GROUP". The logo consists of two overlapping shapes: a pink circle on the left containing horizontal lines, and a white hexagon on the right containing the letters "HG" in blue. The text "SRITONG GROUP" is written in blue below the logo. #### 7.0 Substantial Equivalent Based on Assessment of Non-clinical Performance Data: The performance test data of the non-clinical tests that support a determination of substantial equivalence is the same as mentioned in the previous section (ASTM Requirements). #### 8.0 Substantial Equivalent Based on Assessment of Clinical Performance Data: No Clinical testing was required to determine substantial equivalence of this device. #### 9.0 Conclusion: Based on the comparison of the intended use, technological characteristics and non-clinical performance test data, the Subject Device HG PRO® Nitrile Powder Free Examination Glove is substantially equivalent to the Predicate Device K022548