Fusion Black Powder-Free Nitrile Exam Glove

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name in a circular arrangement around an emblem. The emblem consists of a stylized caduceus-like symbol with three human profiles facing right, representing health and human services. The text reads 'DEPARTMENT OF HEALTH & HUMAN SERVICES - USA'. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 18, 2015 Halyard Health Ms. Christine L Macauley Technical Leader, Regulatory Affairs 5405 Windward Parkway Alpharetta, GA 30004 Re: K150113 Trade/Device Name: Fusion Black Powder-Free Nitrile Exam Glove Regulation Number: 21 CFR 880.6250 Regulation Name: Medical Exam Gloves Regulatory Class: I Product Code: LZA Dated: May 19, 2015 Received: May 21, 2015 Dear Ms. Macauley: 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. {1}------------------------------------------------ Page 2 - Ms. Macauley 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 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, Tejashri Purohit-Sheth, M.D. Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR Erin I. Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K150113 #### Device Name Halyard® Fusion Black Powder-Free Nitrile Exam Glove The Halyard ® Fusion Black Powder-Free Nitrile Exam 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) | Prescription Use (Part 21 CFR 801 Subpart D) X | 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}------------------------------------------------ # Section 2 – 510(k) Summary | Date Summary was<br>Prepared: | June 16, 2015 | |-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Submitter: | Christine L. Macauley<br>Regulatory Affairs Technical Leader<br>Halyard Health<br>5405 Windward Parkway<br>Alpharetta, GA 30004<br>Ph: 470-448-5158<br>Email: Chris.Macauley@hyh.com | | Primary Contact for<br>this 510(k)<br>Submission: | Same<br>Halyard Health<br>5405 Windward Parkway<br>Alpharetta, GA 30004 | | Device Trade<br>Name: | Halyard® Fusion Black Powder-Free Nitrile Exam Glove | | Device Common<br>Name: | Medical Exam Gloves | | Device Product<br>Code and<br>Classification<br>Name: | LZA<br>Class I, 21 CFR §880.6250<br>Patient Examination Glove | | Predicate Device: | K081260<br>Kimberly-Clark Lavender Nitrile Powder-Free Exam Gloves | | Subject Device<br>Description: | Halyard® Fusion Black Powder-Free Nitrile Exam Gloves are disposable, black-colored, nitrile,<br>powder-free, textured fingertip, ambidextrous, non-sterile patient examination gloves which are<br>chlorinated on the donning side and are packed in a cardboard dispenser box. | | Intended Use: | The Halyard® Fusion Powder-Free Nitrile Exam Glove is a disposable device intended for<br>medical purposes that is worn on the examiner's hand to prevent contamination between<br>patient and examiner. | | | Subject Device | Predicate Device<br>K081260 | Substantially<br>Equivalent | |----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------| | FDA Product Code | LZA | LZA | Yes | | FDA Classification | Class 1 | Class 1 | Yes | | Common Name | Medical Exam Glove | Medical Exam Glove | Yes | | Device Trade Name | Halyard Fusion Black Nitrile Powder-<br>Free Exam Glove | Kimberly-Clark Lavender Nitrile Powder-<br>Free Exam Glove | Yes | | Intended Use | The Halyard Fusion Black Powder-<br>Free Nitrile Exam Glove is a<br>disposable device intended for<br>medical purposes that is worn on the<br>examiner's hand to prevent<br>contamination between patient and<br>examiner. | The Kimberly-Clark Lavender Nitrile<br>Powder-Free Nitrile Exam Glove is a<br>disposable device intended for<br>medical purposes that is worn on the<br>examiner's hand to prevent<br>contamination between patient and<br>examiner. | Yes | | | Subject Device | Predicate Device<br>K081260 | Substantially<br>Equivalent | | Technological<br>Characteristics | Black colored, nitrile, powder-free,<br>textured fingertip, ambidextrous, non-<br>sterile patient examination glove. | Lavender colored, nitrile, powder-free,<br>textured fingertip, ambidextrous, non-<br>sterile patient examination glove. | Yes | | Performance Data | | | | | ASTM D5151 Standard Test<br>Method for Detection of<br>Holes in Medical Gloves | Testing of the subject device shows it<br>meets the 2.5 AQL requirement in the<br>standards for leakage. The device<br>meets the acceptance criteria of the<br>standard. | Testing of the subject device shows it<br>meets the 2.5 AQL requirement in the<br>standards for leakage. The device meets<br>the acceptance criteria of the standard. | Yes | | ASTM D6319 Standard<br>Specification for Nitrile<br>Examination Gloves for<br>Medical Applications | The physical dimensions of the<br>subject device are within the limits of<br>the standard and the physical<br>properties of the subject device meet<br>the requirements for tensile strength<br>and elongation in the standard.<br>Therefore the device meets the<br>acceptance criteria of the standard. | The physical dimensions of the subject<br>device are within the limits of the standard<br>and the physical properties of the subject<br>device meet the requirements for tensile<br>strength and elongation in the standard.<br>Therefore the device meets the<br>acceptance criteria of the standard. | Yes | | ASTM D6124 Standard Test<br>Method for Residual Powder<br>on Medical Gloves | Residual powder on the subject<br>device is within the powder-free limit<br>of $<$ 2 $mg$ maximum powder per glove<br>and meets the acceptance criteria for<br>powder-free. | Residual powder on the subject device is<br>within the powder-free limit of $<$ 2 $mg$ maximum powder per glove and meets<br>the acceptance criteria for powder-free. | Yes | | ISO 10993-10 Biological<br>evaluation of medical<br>devices -Tests for Irritation | Acceptance criteria: Erythema/<br>edema up to 72 hours post exposure.<br>Result: Erythema/edema was<br>negligible. Meets acceptance criteria. | Acceptance criteria: Erythema/edema<br>up to 72 hours post exposure.<br>Result: Erythema/edema was negligible.<br>Meets acceptance criteria. | Yes | | ISO 10993-10 Biological<br>evaluation of medical<br>devices -Tests for Skin<br>Sensitization | Acceptance criteria: No evidence of<br>delayed dermal contact sensitivity at<br>24 and 48 hours post injection.<br>Result: Not a sensitizer under<br>conditions of the study. Meets<br>acceptance criteria. | Acceptance criteria: No evidence of<br>delayed dermal contact sensitivity at 24<br>and 48 hours post injection.<br>Result: Not a sensitizer under conditions<br>of the study. Meets acceptance criteria. | Yes | | ISO 10993 Biological<br>evaluation of medical<br>devices - Tests for Systemic<br>Toxicity | Acceptance criteria: No signs of<br>systemic toxicity up to 72 hours post<br>injection.<br>Result: No systemic toxicity<br>observed. Meets acceptance criteria. | Acceptance criteria: No signs of<br>systemic toxicity up to 72 hours post<br>injection.<br>Result: No systemic toxicity observed.<br>Meets acceptance criteria. | Yes | | Conclusion | The performance data support the conclusion that the subject device is as safe, as effective, and<br>performs as well as the legally marketed device that was submitted and cleared under K081260. | | | {4}------------------------------------------------ ## Halyard Health 510(k) for the Halyard® Fusion Black Powder-Free Nitrile Exam Glove – 510(k) Summary #### Technological Characteristics and Substantial Equivalence: The Halyard® Fusion Black Powder-Free Nitrile Exam Glove is substantially equivalent to the predicate device, Kimberly-Clark Lavender Nitrile Powder-Free Exam Gloves (K081260). The only difference is the addition of fourteen pigments that have been tested for biocompatibility. This addition of pigments raises no new issues of safety and efficacy as demonstrated by testing of biocompatibility and technical product performance as described in this 510(k) submission. {5}------------------------------------------------ ### Halyard Health of Clinical Tests: 510(k) for the Halyard® Fusion Black Powder-Free Nitrile Exam Glove – 510(k) Summary - Summary of Testing: These gloves have been tested for conformance to the applicable sections of the following standards: ASTM D5151-06 Standard Test Method for Detection of Holes in Medical Gloves ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Applications ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves ISO 10993-10 Biological evaluation of medical devices -Tests for Irritation and Skin Sensitization ISO 10993-11 Biological evaluation of medical devices - Tests for Systemic Toxicity ALL RESULTS OF TESTING MET ACCEPTANCE CRITERIA. Brief Description No new clinical tests were required to support this 510(k) notification. CONCLUSION: The performance data support the conclusion that the subject device is as safe, as effective, and performs as well as the legally marketed device that was submitted and cleared under K081260.