EMG WHITE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 7,2014 Eco Medi Glove SDN BHD Mr. Suresh Kumar Quality Assurance Manager Lot 23836, Jalan Tembaga Kuning Kamunting Raya Industrial Estate Kamunting Perak, Malaysia 34600 Re: K141510 Trade/Device Name: EMG White Nitrile Examination Gloves Powder Free Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: September 5, 2014 Received: September 5, 2014 Dear Mr. Suresh Kumar: 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 {1}------------------------------------------------ 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 device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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, Susan Runnan DDS, mA 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}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K141510 Device Name EMG White Nitrile Medical Examination Gloves Powder Free Indications for Use (Describe) A Powder Free Patient examination gloves 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 Type of Use (Select one or both, as applicable) - Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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}------------------------------------------------ formerly known as Sinetimed Consumables Sdn. Bhd. t 23826, Jalan Tembaga Kuning, Kaya Industrial Estate, 34600 Taiping, Perak Darul Ridzuan. MALAYSIA, TEL +60-5-891 2777 FAX +60-5-891 2999 > Appendix 2 510K#: K141510 # 510(K) Summary EMG White Nitrile Medical Examination Glove Powder Free . ### 1.0 Submitter : | Company Name | : ECO MEDI GLOVE SDN. BHD | |-----------------|-------------------------------------------------------------------------------------------------------------| | Company Address | : Lot 23826,Jalan Tembaga Kuning<br>Kamunting Raya Industrial Estate,<br>34600,Kamunting Perak<br>Malaysia. | | Contact Person | : Mr Suresh Kumar | | Telephone No | : 603-60283033 | | Email | : suresh@ecomediglove.com.my | - 2.0 Preparation Date : 22th September 2014 ### 3.0 Name of the Device Trade Name / Proprietary Name : EMG White Nitrile Medical Examination Gloves Powder Free Device Name : Nitrile Patient Examination gloves Device Classification Name : Patient Examination gloves (21 CFR 880.6250) Device Class : Class I Product Code : Nitrile-LZA {4}------------------------------------------------ (formerly known as Sinetimed Consumables Sdn. Bhd.) Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA. Appendix 2 510K#: K141510 ### 4.0 Identification of The Legally Marketed Device : Class I patient Examination gloves,Powder Free,LZA which meets all the requirement of ASTM D 6319-10 and FDA 21 CFR 880.6250.It is equivalent to K112928, RS White Nitrile Medical Examination Gloves Powder Free ( Non-Sterile ) ### 5.0 Description of Device White Nitrile Medical Examination gloves powder free, non sterile, as described in this 510(k) Notification is substantially equivalent to the current class I patient examination gloves with product Code LZA (21CFR 880.6250). It meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. They are made nitrile from nitrile latex compound, white colour, powder free and non sterile. This White Nitrile Medical Examination Gloves Powder Free 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 {5}------------------------------------------------ (formerly known as Sinetimed Consumables Sdn. Bhd.) 26, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA. 60-5-891 2777 > Appendix 2 510K#: K141510 ## 6.1. Specification for Nitrile gloves: 6.1.1 Dimension and Thickness of Gloves | Dimension | Size S | Size M | Size L | Size XL | |------------------------------|---------|---------|---------|---------| | Overall Length (mm) | 230min | 230min | 230min | 230min | | Width (± 5mm) | 85 | 95 | 105 | 115 | | Thickness at Palm (mm) | 0.05min | 0.05min | 0.05min | 0.05min | | Thickness at Finger Tip (mm) | 0.05min | 0.05min | 0.05min | 0.05min | ## 6.3.2.2 Gloves Physical Properties and Holes | Measurement | Before Ageing | After Aging at 70°C for<br>168 hrs @ 100°C for 22 hrs | |-------------------------|---------------------------------|-------------------------------------------------------| | Tensile Strength (MPa) | 14min | 14 Min | | Ultimate Elongation (%) | 500min | 400min | | Pin-hole Level | AQL 2.5<br>Inspection Level G-1 | AQL 2.5<br>Inspection Level G-1 | Gloves meet all the specification listed in ASTM D 6319-10 ### 7.0 Intended use of the Device A powder-free 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. It is for over-the-counter use. ## 8.0 Summary of the Technological Characteristics of the Device compared to the Predicate Device for substantial equivalent discussion There is no different technology characteristics compared to the predicate device . Gloves are made from nitrile latex compound, White colour, powder free and non sterile. It is equivalent to K112928, RS White Nitrile Medical Examination Gloves Powder Free ( Non-Sterile ) {6}------------------------------------------------ (formerly known as Sinetimed Consumables Sdn. Bhd.) Lot 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA. TEL +60-5-891 2777 FAX +60-5-891 2999 # Appendix 2 510K#: K141510 | Characteristics | Acceptance Criteria | EMG White Nitrile<br>Medical Examination<br>Gloves<br>Powder Free,K141150 | RS White Nitrile<br>Medical Examination<br>Gloves Powder Free<br>(Non-Sterile ) K112928 | |---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | LZA | LZA | LZA | | Intended use | A powder free patient<br>examination glove is a<br>disposable device intended for<br>medical purposes that is worn<br>on the examiner's hand or<br>finger to prevent<br>contamination between patient<br>and examiner. The device is<br>for over-the-counter<br>use. Intended use | A powder free patient<br>examination glove is a<br>disposable device<br>intended for medical<br>purposes that is worn on<br>the examiner's hand or<br>finger to prevent<br>contamination between<br>patient and examiner.<br>The device is for over-<br>the-counter use. | A powder free patient<br>examination glove is a<br>disposable device intended<br>for medical purposes that is<br>worn on the examiner's<br>hand or finger to prevent<br>contamination between<br>patient and examiner. The<br>device is for over-the-<br>counter use. | | Material use | Not made from Natural Rubber<br>Latex | Nitrile latex compound | Nitrile latex compound | | Colour | White | White | White | | Sterility | Non sterile | Non sterile | Non sterile | | Dimensions | Overall Length (mm)<br>= Min 230mm<br><br>Width (± 5mm)<br>Size S = 85mm<br>Size M = 95mm<br>Size L = 105mm<br>Size XL = 115mm<br><br>Thickness at Palm (mm)<br>= Min 0.05min<br><br>Thickness at Finger Tip (mm)<br>= Min 0.05min | Meets ASTM D6319-10 | Meets ASTM D6319-10 | | | | | | | Physical properties | Before Ageing<br>Tensile Strength (MPa)<br>= Min 14min<br>Ultimate Elongation (%)<br>= Min 500min<br>After Aging at 70°C for<br>168 hrs @ 100°C for 22 hrs<br>Tensile Strength (MPa)<br>= Min 14min<br>Ultimate Elongation (%)<br>= Min 400min | Meets ASTM D6319-10 | Meets ASTM D6319-10 | | Freedom from pinholes | AQL 2.5<br>Inspection Level G-1 | Meets ASTM D5151-06 | Meets ASTM D5151-06 | | Residual Powder | ≤ 2.0 mg/pc | Meets ASTM D6124-06 | Meets ASTM D6124-06 | | Biological Evaluation on<br>Medical Device -<br>Primary Skin Irritation<br>Test | Test Article was non irritant | Under the conditions of<br>this study, the test article<br>was a non-irritant | Under the conditions of<br>this study, the test article<br>was a non-irritant | | Biological Evaluation on<br>Medical Device-<br>Dermal Sensitization<br>Assay | Test Article was non sensitizer | Under the conditions of<br>this study, the test article<br>was a non-sensitizer. | Under the conditions of<br>this study, the test article<br>was a non-sensitizer. | {7}------------------------------------------------ (formerly known as Sinetimed Consumables Sdn. Bhd.) Lot 23826, Jalan Tembaga Kuning, Kamunting Raya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA. TEL +60-5-891 2777 FAX +60-5-891 2999 > Appendix 2 510K#: K141510 {8}------------------------------------------------ (formerly known as Sinetimed Consumables Sdn. Bhd.) Lot 23826, Jalan Tembaga Kuning, Kaya Industrial Estate, 34600 Taiping. Perak Darul Ridzuan. MALAYSIA. TEL +60-5-891 2777 FAX +60-5-891 2999 > Appendix 2 510K#: K141510 # 9.0 Conclusion It can be concluded that EMG White Nitrile Medical Examination Gloves Powder Free and predicate devices are substantially equivalent base on intended uses, physical properties, technological characteristics and non-clinical performance