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.

Device Description

Halyard® Fusion Black Powder-Free Nitrile Exam Gloves are disposable, black-colored, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination gloves which are chlorinated on the donning side and are packed in a cardboard dispenser box.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Halyard® Fusion Black Powder-Free Nitrile Exam Glove, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test Standard	Acceptance Criteria	Reported Device Performance
ASTM D5151 Standard Test Method for Detection of Holes in Medical Gloves	Meets the 2.5 AQL (Acceptable Quality Level) requirement for leakage.	Testing of the subject device shows it meets the 2.5 AQL requirement in the standards for leakage. The device meets the acceptance criteria of the standard.
ASTM D6319 Standard Specification for Nitrile Examination Gloves for Medical Applications	Physical dimensions are within the standard limits. Physical properties (tensile strength and elongation) meet the standard requirements.	The physical dimensions of the subject device are within the limits of the standard and the physical properties of the subject device meet the requirements for tensile strength and elongation in the standard. Therefore, the device meets the acceptance criteria of the standard.
ASTM D6124 Standard Test Method for Residual Powder on Medical Gloves	Residual powder is within the powder-free limit of < 2 mg maximum powder per glove.	Residual powder on the subject device is within the powder-free limit of < 2 mg maximum powder per glove and meets the acceptance criteria for powder-free.
ISO 10993-10 Biological evaluation of medical devices - Tests for Irritation	Erythema/edema up to 72 hours post exposure. (Implicitly, the criteria is for negligible erythema/edema based on the result.)	Erythema/edema was negligible. Meets acceptance criteria.
ISO 10993-10 Biological evaluation of medical devices - Tests for Skin Sensitization	No evidence of delayed dermal contact sensitivity at 24 and 48 hours post injection.	Not a sensitizer under conditions of the study. Meets acceptance criteria.
ISO 10993 Biological evaluation of medical devices - Tests for Systemic Toxicity	No signs of systemic toxicity up to 72 hours post injection.	No systemic toxicity observed. Meets acceptance criteria.

Study Information:

The provided document describes a 510(k) premarket notification, which demonstrates substantial equivalence to a predicate device rather than a de novo clinical study proving novel performance. The "study" here refers to the testing conducted to show the device meets recognized standards.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample sizes used for the individual tests (ASTM D5151, D6319, D6124, ISO 10993 series). It only implies that "testing of the subject device" was performed.

The data provenance is not specified in terms of country of origin. The data is presented as retrospective in the sense that these tests were conducted on the device to demonstrate compliance with established standards for a premarket submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable in the context of this submission. The "ground truth" for medical exam gloves typically refers to their physical properties and biocompatibility, which are assessed objectively through standardized laboratory tests, not through expert consensus on diagnostic images or clinical outcomes. The "experts" would be the personnel conducting and interpreting the standardized laboratory tests, whose qualifications are governed by the respective test methodologies and good laboratory practices.

4. Adjudication Method for the Test Set:

This is not applicable. As these are objective laboratory tests against defined numerical or qualitative criteria in recognized standards, there is no need for an adjudication method among experts. The results are either within spec or out of spec.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, with and without AI assistance, to assess improvements in performance. Medical exam gloves do not involve human interpretation in this manner.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No, a standalone (algorithm only) performance study was not done in the context of AI. This device is a physical medical exam glove, not an algorithm or AI system. The performance is assessed through its physical and biological properties.

7. The Type of Ground Truth Used:

The ground truth used for this device is based on established industry standards and regulatory requirements for the physical, chemical, and biological properties of medical exam gloves. These include:

Quantitative measurements: For dimensions, tensile strength, elongation, and residual powder.
Qualitative and semi-quantitative assessments: For leakage (AQL), irritation (erythema/edema), skin sensitization, and systemic toxicity.
These are based on the criteria defined within ASTM and ISO standards.

8. The Sample Size for the Training Set:

Not applicable. This submission is for a physical medical device, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As stated above, there is no training set involved for this type of device.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known) K150113

Device Name

Halyard® Fusion Black Powder-Free Nitrile Exam Glove

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)

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Section 2 – 510(k) Summary

Date Summary wasPrepared:	June 16, 2015
510(k) Submitter:	Christine L. MacauleyRegulatory Affairs Technical LeaderHalyard Health5405 Windward ParkwayAlpharetta, GA 30004Ph: 470-448-5158Email: Chris.Macauley@hyh.com
Primary Contact forthis 510(k)Submission:	SameHalyard Health5405 Windward ParkwayAlpharetta, GA 30004
Device TradeName:	Halyard® Fusion Black Powder-Free Nitrile Exam Glove
Device CommonName:	Medical Exam Gloves
Device ProductCode andClassificationName:	LZAClass I, 21 CFR §880.6250Patient Examination Glove
Predicate Device:	K081260Kimberly-Clark Lavender Nitrile Powder-Free Exam Gloves
Subject DeviceDescription:	Halyard® Fusion Black Powder-Free Nitrile Exam Gloves are disposable, black-colored, nitrile,powder-free, textured fingertip, ambidextrous, non-sterile patient examination gloves which arechlorinated 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 formedical purposes that is worn on the examiner's hand to prevent contamination betweenpatient and examiner.

	Subject Device	Predicate DeviceK081260	SubstantiallyEquivalent
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-Free Exam Glove	Kimberly-Clark Lavender Nitrile Powder-Free Exam Glove	Yes
Intended Use	The Halyard Fusion Black Powder-Free Nitrile Exam Glove is adisposable device intended formedical purposes that is worn on theexaminer's hand to preventcontamination between patient andexaminer.	The Kimberly-Clark Lavender NitrilePowder-Free Nitrile Exam Glove is adisposable device intended formedical purposes that is worn on theexaminer's hand to preventcontamination between patient andexaminer.	Yes
	Subject Device	Predicate DeviceK081260	SubstantiallyEquivalent
TechnologicalCharacteristics	Black colored, nitrile, powder-free,textured fingertip, ambidextrous, non-sterile patient examination glove.	Lavender colored, nitrile, powder-free,textured fingertip, ambidextrous, non-sterile patient examination glove.	Yes
Performance Data
ASTM D5151 Standard TestMethod for Detection ofHoles in Medical Gloves	Testing of the subject device shows itmeets the 2.5 AQL requirement in thestandards for leakage. The devicemeets the acceptance criteria of thestandard.	Testing of the subject device shows itmeets the 2.5 AQL requirement in thestandards for leakage. The device meetsthe acceptance criteria of the standard.	Yes
ASTM D6319 StandardSpecification for NitrileExamination Gloves forMedical Applications	The physical dimensions of thesubject device are within the limits ofthe standard and the physicalproperties of the subject device meetthe requirements for tensile strengthand elongation in the standard.Therefore the device meets theacceptance criteria of the standard.	The physical dimensions of the subjectdevice are within the limits of the standardand the physical properties of the subjectdevice meet the requirements for tensilestrength and elongation in the standard.Therefore the device meets theacceptance criteria of the standard.	Yes
ASTM D6124 Standard TestMethod for Residual Powderon Medical Gloves	Residual powder on the subjectdevice is within the powder-free limitof $<$ 2 $mg$ maximum powder per gloveand meets the acceptance criteria forpowder-free.	Residual powder on the subject device iswithin the powder-free limit of $<$ 2 $mg$ maximum powder per glove and meetsthe acceptance criteria for powder-free.	Yes
ISO 10993-10 Biologicalevaluation of medicaldevices -Tests for Irritation	Acceptance criteria: Erythema/edema up to 72 hours post exposure.Result: Erythema/edema wasnegligible. Meets acceptance criteria.	Acceptance criteria: Erythema/edemaup to 72 hours post exposure.Result: Erythema/edema was negligible.Meets acceptance criteria.	Yes
ISO 10993-10 Biologicalevaluation of medicaldevices -Tests for SkinSensitization	Acceptance criteria: No evidence ofdelayed dermal contact sensitivity at24 and 48 hours post injection.Result: Not a sensitizer underconditions of the study. Meetsacceptance criteria.	Acceptance criteria: No evidence ofdelayed dermal contact sensitivity at 24and 48 hours post injection.Result: Not a sensitizer under conditionsof the study. Meets acceptance criteria.	Yes
ISO 10993 Biologicalevaluation of medicaldevices - Tests for SystemicToxicity	Acceptance criteria: No signs ofsystemic toxicity up to 72 hours postinjection.Result: No systemic toxicityobserved. Meets acceptance criteria.	Acceptance criteria: No signs ofsystemic toxicity up to 72 hours postinjection.Result: No systemic toxicity observed.Meets acceptance criteria.	Yes
Conclusion	The performance data support the conclusion that the subject device is as safe, as effective, andperforms as well as the legally marketed device that was submitted and cleared under K081260.

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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.

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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.

Regulation Number and Section

§ 880.6250 Non-powdered patient examination glove.

(a)
Identification. A non-powdered 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. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.