NITRITECH OR MULTIPLE PRIVATE LABEL NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVE

{0}------------------------------------------------ ## 510K Summary . / - ﺴ ## 510K: 093517 | <b>1. Information</b> | | | | |-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|--| | | Submitter's | | | | | Name: | Summit Glove Inc. | | | | Address: | 310 South Grant Street | | | | | Minerva, Ohio 44657 | | | | Phone: | 330-868-0066 | | | | Contact Person: | James Moore | | | | E-mail: | jmoore@summitglove.com | | | <b>2. Name of Device</b> | | | | | | Trade or Proprietary Name: | NitriTech®, Non-Sterile Powder-Free Nitrile<br>Examination Glove in the color blue | | | | Common or Usual Name: | Synthetic Rubber Examination Gloves | | | | Classification Name: | Patient Examination Glove, Powder-Free | | | <b>3. Predicate Device:</b> | | | | | | Non-Sterile Nitrile Powder-Free Medical Examination<br>Gloves Submission Number: K090828. Based on the below<br>test results, it is concluded the subject gloves are a<br>substantial equivalent to the predicate device. | | | #### 4. Identification of the Legally Marketed Devices Powder-Free Nitrile Examination Gloves as described in this 510K Notification is substantially equivalent to the Class 1 patient examination glove bearing the product code 80LZA (21CFR 880.6250). It meets all the current specifications listed under the ASTM Specification D6319-00a, Standard for Nitrile Gloves for Medical Application. #### 5. Description of Device Powder-Free Nitrile Medical Examination Gloves meets the current specifications listed under the ASTM Specification D6319-00a, Standard Specification for Nitrile Examination Gloves for Medical Application. #### 6. Intended Use of Gloves This is a disposable device intended for medical purposes: that is worn on the examiner hand, to prevent contamination between the patient and examiner. {1}------------------------------------------------ ## 7. Summary of Performance Data: Performance data of gloves based on ASTM D6319-00a. ASTM D6319-00a Section 9 is inapplicable for non-sterile examination grade nitrile gloves. | Test | ASTM 6319-00a | Powder-Free Nitrile<br>Examination Gloves | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|--------------------------------------------------| | 1. Detection of Holes (ASTM<br>5151) | Multiple Normal<br>G1<br>AQL = 2.5 | Pass G1 AQL = 2.5* | | 2. Length (mm)<br>Size XS<br>S<br>M<br>L<br>XL | Min 220 -<br>Min 220 -<br>Min 230 -<br>Min 230 -<br>Min 230 | 240 mm minimum for all<br>sizes* | | 3. Palm Width (mm)<br>Size XS<br>S<br>M<br>L<br>XL | 70+ 10<br>80+ 10<br>95+ 10<br>111+ 10<br>120 + 10 | 73-78<br>83-88<br>93-98<br>103-107<br>110 - 118* | | 4. Thickness (mm)<br>Finger<br>Palm | Min 0.05<br>Min 0.05 | Min 0.06<br>Min 0.05* | | 5. Physical Properties<br>Before Aging<br>Tensile Strength (Mpa)<br>Ultimate Elongation (%)<br>After Aging<br>Tensile Strength (Mpa)<br>Ultimate Elongation (%) | Min 14<br>Min 500<br>Min 14<br>Min 400 | 15 - 21<br>550 - 630*<br>14 - 22<br>520 - 610* | | 6. Powder Content | Max 2.0mg/glove | Below 2.0mg/glove | | 7. Primary Skin Irritation CPSC<br>Title 16 Chapter II Part 1500 | PII Greater or equal to 5.0<br>indicates an irritate | PII was "0.04"* | | 8. Dermal Sensitization Test ISO<br>10993-10 | Score greater or equal to 1<br>indicates<br>irritation/hypersensitivity | Score was "0"* | *Third Party test data is available in Appendix A The performance data of the gloves as shown above meet the ASTM D6319-00a Standard using the following test methods: {2}------------------------------------------------ - ASTM D412 Tensile Properties Unaged Test Method A ● - ASTM D573 Tensile Properties Aged . - ASTM D5151 Detection of Holes . - ASTM D6124-06 Section 7 Procedure I for Powder-free Gloves . - 8. The Biocompatibility Test consists of Primary Skin Irritation (CPSC Title 16 Chapter II Part 1500) and Dermal Sensitization Tests (ISO 10993-10). *Third Party test data is available in Amendment F The conclusion of the Biocompatibility Testing would indicate that there is no irritation or hypersensitivity to the subject gloves (NitriTech® Non-Sterile Powder-Free Nitrile Examination Gloves in the color blue). ### 9. Conclusion: It is concluded that the NitriTech® Non-Sterile Powder-Free Nitrile Examination Gloves in the color blue for this submission meets ASTM D6319-00a, CPSC Title 16 Chapter II Part 1500 and ISO 10993-10 requirements. {3}------------------------------------------------ ### Statement concerning the Biocompatibility Testing The gloves tested in the Biocompatibility Testing were the subject glove (NitriTech®, Non-Sterile Powdered Nitrile Examination Gloves in the color blue) of this submission. Mediamal Testing and Consultancy Services had the Primary Skin Irritation (study report # MB-PSI-27-09) and Dermal Sensitization Test (study report # MB-DSAb-27-09) completed to CPSC Title 16 Chapter II Part 1500 and ISO 10993-10 standards. 18 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or body. The graphic is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 # JUN 2 9 2010 Mr. James Moore Project Coordinator Summit Glove, Incorporated 310 South Grant Street Minerva, Ohio 44657 Re: K093517 Trade/Device Name: NitriTech® Non-Sterile Powdered Nitrile Medical Examination Gloves in the color blue Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: June 10, 2010 Received: June 15, 2010 Dear Mr. Moore: 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. {5}------------------------------------------------ #### Page 2- Mr. Moore 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 reportung (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.goy/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/Resourcesfor You/Industry/default.htm. f Sincerely yours Susan Runner Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure . {6}------------------------------------------------ # Indications for Use 510(k) Number (if known): K093517 Device Name: NitriTech® Non-Sterile Powder Free Nitrile Medical Examination Gloves in the color blue. Indications For Use: The nitrile examination gloves are a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between the patient and examiner. AND/OR Over-The-Counter Use Prescription Use × (Part 21 CFR 801 Subpart D) (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 (Division-Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices K093517 510(k) Number: _______________________________________________________________________________________________________________________________________________________________