The Halyard Lavender Nitrile Powder-Free 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. These gloves were tested for use with the following chemotherapy drugs:

Cyclophosphamide (20.0 mg/ml) No breakthrough up to 240 minutes
Doxorubicin HCl (2.0 mg/ml) No breakthrough up to 240 minutes
Etoposide (20.0 mg/ml) No breakthrough up to 240 minutes
5-Fluorouracil (50.0 mg/ml) No breakthrough up to 240 minutes
Paclitaxel (Taxol) (6.0 mg/ml) No breakthrough up to 240 minutes
Cisplatin (1.0 mg/ml) No breakthrough up to 240 minutes
Dacarbazine (10.0 mg/ml) No breakthrough up to 240 minutes
Ifosfamide (50.0 mg/ml) No breakthrough up to 240 minutes
Mitoxantrone (2.0 mg/ml) No breakthrough up to 240 minutes
Vincristine sulfate (1.0 mg/ml) No breakthrough up to 240 minutes
Carmustine (3.3 mg/ml) No breakthrough up to 0.3 minutes
ThioTEPA (10.0 mg.ml) No breakthrough up to 30.9 minutes
Warning: Not for Use With : Carmustine, ThioTEPA

Device Description

Halyard® Lavender Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs are disposable, lavender-colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination gloves that are packed in a cardboard dispenser box.

AI/ML Overview

The provided text describes the regulatory clearance (510(k)) for a medical device: "Halyard® Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs". This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than a clinical study evaluating AI-powered diagnostic performance. Therefore, many of the requested elements for AI/diagnostic device acceptance criteria and study design (e.g., number of experts, adjudication methods, MRMC studies, standalone performance, training sets) are not applicable to this type of device and regulatory submission.

However, I can extract the acceptance criteria and performance data relevant to this product, which primarily involve physical and chemical resistance standards for medical gloves.

Here's the information gleaned from the provided text, adapted to the context of this device:

Device: Halyard® Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs

Type of Regulatory Submission: 510(k) Premarket Notification (demonstrates substantial equivalence to a predicate device)

Study Focus: Performance of the glove against established consensus standards for medical gloves and resistance to chemotherapy drug permeation. This is not a study evaluating AI diagnostic performance or human reader improvement.

1. Table of Acceptance Criteria and Reported Device Performance

Standard/Test	Acceptance Criteria	Reported Device Performance (Halyard Lavender Nitrile Powder-Free Exam Glove)
ASTM D6978-05 Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs	Breakthrough times for listed chemotherapy drugs (the specific criteria for each drug are implied by the "No breakthrough up to X minutes" statement for the predicate and subject device, along with the warning for Carmustine and ThioTEPA). The underlying acceptance criterion would be defined by the manufacturer's target for 'no breakthrough' for the specific duration of use they claim.	No signs of breakthrough after 4 hours for 10 drugs:• Cyclophosphamide (20.0 mg/ml): No breakthrough up to 240 minutes• Doxorubicin HCl (2.0 mg/ml): No breakthrough up to 240 minutes• Etoposide (20.0 mg/ml): No breakthrough up to 240 minutes• 5-Fluorouracil (50.0 mg/ml): No breakthrough up to 240 minutes• Paclitaxel (Taxol) (6.0 mg/ml): No breakthrough up to 240 minutes• Cisplatin (1.0 mg/ml): No breakthrough up to 240 minutes• Dacarbazine (10.0 mg/ml): No breakthrough up to 240 minutes• Ifosfamide (50.0 mg/ml): No breakthrough up to 240 minutes• Mitoxantrone (2.0 mg/ml): No breakthrough up to 240 minutes• Vincristine sulfate (1.0 mg/ml): No breakthrough up to 240 minutesWarning / Limited Breakthrough:• Carmustine (3.3 mg/ml): No breakthrough up to 0.3 minutes• ThioTEPA (10.0 mg/ml): No breakthrough up to 30.9 minutesResult: Meets acceptance criteria. (Note: The product warning explicitly states "Not for Use With: Carmustine, ThioTEPA" due to these short breakthrough times.)
ASTM D5151-06 Standard Test Method for Detection of Holes in Medical Gloves	Meets 2.5% AQL (Acceptable Quality Level) requirement for leakage.	Actual AQL of 1.0% (lower is better, indicating fewer holes).
ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves	Powder-free limit of < 2 mg maximum powder per glove.	Average of 0.04 mg/glove (within the powder-free limit).
ASTM D6319-10 Standard Specification for Nitrile Examination Gloves for Medical Applications	Physical dimensions within standard limits. Physical properties meet requirements for tensile strength (e.g., specific MPa before and after aging) and elongation (e.g., specific % before and after aging). Implied minimums are 15 MPa tensile strength before aging and 14 MPa after aging, and 500% elongation before aging and 400% after aging based on predicate.	Physical Dimensions: Within the limits of the standard.Tensile Strength: Average before aging of 30.56 MPa and after aging of 37.53 MPa.Elongation: 593% before aging and 533% after aging.
ISO 10993-10: 2010 Biological evaluation of medical devices - Part 10: Tests for Irritation and Skin Sensitization	Not found to cause a sensitizing response or an irritation response in the animal model.	Subject device extracts (polar and non-polar) were not found to cause a sensitizing response or an irritation response in the animal model.
ISO 10993-11: 2006 Biological evaluation of medical devices - Part 11: Tests for Systemic Toxicity	Not found to cause a systemic response in the animal model.	Subject device extracts (polar and non-polar) were not found to cause a systemic response in the animal model.

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

The document doesn't explicitly state the exact sample sizes for each test (e.g., number of gloves tested for holes, powder). However, it indicates compliance with recognized consensus standards (e.g., ASTM D5151-06, ASTM D6319-10, ASTM D6978-05). These standards prescribe specific sampling plans and test methodologies.

Data Provenance: The studies were conducted by the manufacturer, Halyard Health, Inc., based in Alpharetta, Georgia, USA. The data is prospective, generated specifically for this 510(k) submission to demonstrate compliance with the referenced standards. The country of origin of the data would therefore be the USA.

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

This question is not applicable to this type of device and study. The "ground truth" for glove performance is established by the specified methodologies and measurement limits defined within the ASTM and ISO standards themselves, not by human expert consensus or interpretation of images. The tests are laboratory-based, objective measurements (e.g., time to breakthrough, AQL for holes, mg of powder, tensile strength).

4. Adjudication Method for the Test Set:

None. As explained above, the tests are objective laboratory measurements, not subjective human interpretations requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

No. An MRMC study is relevant for AI-assisted diagnostic devices where human readers interpret medical images or data. This document describes the physical and chemical properties of a medical glove.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This question is not applicable. The device is a physical glove, not an algorithm.

7. The Type of Ground Truth Used:

Objective laboratory measurements and compliance with established consensus standards. The "ground truth" for this device's performance is derived from the results of standardized physical, chemical, and biological tests, as outlined by ASTM and ISO specifications.

8. The Sample Size for the Training Set:

Not applicable. This device does not involve machine learning or AI models, and therefore does not have a "training set" in that context.

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

Not applicable. As above, there is no training set. The "ground truth" for the performance claims relies on the adherence to and results from validated test methods defined by international standards.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Halyard Health Christine Macauley Regulatory Affairs Technical Leader 5405 Windward Parkway Alpharetta. Georgia 30004

Re: K180646

Trade/Device Name: Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: Class I Product Code: LZC. LZA Dated: Jun 11, 2018 Received: June 12, 2018

Dear Christine 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, Isting 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Clarence W. Murray lii III -S

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K180646

Device Name

Halyard Lavender Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs

Indications for Use (Describe)

Cyclophosphamide (20.0 mg/ml) No breakthrough up to 240 minutes Doxorubicin HCl (2.0 mg/ml) No breakthrough up to 240 minutes Etoposide (20.0 mg/ml) No breakthrough up to 240 minutes 5-Fluorouracil (50.0 mg/ml) No breakthrough up to 240 minutes Paclitaxel (Taxol) (6.0 mg/ml) No breakthrough up to 240 minutes Cisplatin (1.0 mg/ml) No breakthrough up to 240 minutes Dacarbazine (10.0 mg/ml) No breakthrough up to 240 minutes Ifosfamide (50.0 mg/ml) No breakthrough up to 240 minutes Mitoxantrone (2.0 mg/ml) No breakthrough up to 240 minutes Vincristine sulfate (1.0 mg/ml) No breakthrough up to 240 minutes Carmustine (3.3 mg/ml) No breakthrough up to 0.3 minutes ThioTEPA (10.0 mg.ml) No breakthrough up to 30.9 minutes Warning: Not for Use With : Carmustine, ThioTEPA

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)

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510(k) Summary-K180646

Date Summarywas Prepared	June 26, 2018
510(k) Submitter	Christine L. MacauleyRegulatory Affairs Technical LeaderHalyard Health, Inc.5405 Windward ParkwayAlpharetta, GA 30004Email: Chris.Macauley@hyh.comPh: 470-448-5158
Primary Contact forthis 510(k) Submission	Same as above
Device Trade Name	Halyard® Lavender Nitrile Powder-Free Exam Glove Tested for Use withChemotherapy Drugs
Device Common Name	Medical Exam Gloves
Device Product Codeand Classification Name	LZCClass I, 21 CFR §880.6250Patient Examination Glove
Predicate Device	K172525Blue Non-Sterile Powder Free Nitrile Examination Gloves Tested for Usewith Chemotherapy Drugs
Reference Device	K081260Kimberly-Clark Lavender Nitrile Powder-Free Exam Gloves
Subject Device Description	Halyard® Lavender Nitrile Powder-Free Exam Gloves Tested for Use withChemotherapy Drugs are disposable, lavender-colored, chlorinated, nitrile,powder-free, textured fingertip, ambidextrous, non-sterile patientexamination gloves that are packed in a cardboard dispenser box. Devicefollows consensus standards:• ASTM D5151-06 Standard Test Method for Detection of Holes inMedical Gloves• ASTM D6319-10 Standard Specification for Nitrile ExaminationGloves for Medical Applications• ASTM D6124-06 Standard Test Method for Residual Powder onMedical Gloves• ASTM D6978-05 Standard Practice for Assessment of Resistance ofMedical Gloves to Permeation by Chemotherapy Drugs• ISO 10993-11:2006, Biological evaluation of medical devices - Part11: Tests for Systemic Toxicity• ISO 10993-10: 2010: Biological evaluation of medical devices - Part10: Tests for Irritation and Skin Sensitization

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Indications for Use	The Halyard® Lavender Nitrile Powder-Free Exam Glove Tested for Use withChemotherapy Drugs is a disposable device intended for medical purposes thatis worn on the examiner's hand to prevent contamination between patient andexaminer. These gloves were tested for use with the following chemotherapydrugs:• Cyclophosphamide (20.0 mg/ml) No breakthrough up to 240 minutes• Doxorubicin HCI (2.0 mg/ml) No breakthrough up to 240 minutes• Etoposide (20.0 mg/ml) No breakthrough up to 240 minutes• 5-Fluorouracil (50.0 mg/ml) No breakthrough up to 240 minutes• Paclitaxel (Taxol) (6.0 mg/ml) No breakthrough up to 240 minutes• Cisplatin (1.0 mg/ml) No breakthrough up to 240 minutes• Dacarbazine (10.0 mg/ml) No breakthrough up to 240 minutes• Ifosfamide (50.0 mg/ml) No breakthrough up to 240 minutes• Mitoxantrone (2.0 mg/ml) No breakthrough up to 240 minutes• Vincristine sulfate (1.0 mg/ml) No breakthrough up to 240 minutes• Carmustine (3.3 mg/ml) No breakthrough up to 0.3 minutes• ThioTEPA (10.0 mg.ml) No breakthrough up to 30.9 minutesWarning: Not for Use With: Carmustine, ThioTEPA
Comparison of TechnologicalCharacteristics	Subject K180646Lavender-colored, 9.5 inch, nitrile,powder-free, textured fingertip,ambidextrous, non-sterile patientexamination glove.	Predicate K172525:Blue-colored, 9.5 inch, nitrile, powder-free, ambidextrous, non-sterile patientexamination glove.
Summary of comparison oftechnological characteristics	There are no different technological characteristics of the subject devicecompared to the predicate device. They are powder-free non-sterile nitrile examgloves tested for resistance to permeation by chemotherapydrugs. Thepredicate device is a different color. This difference does not raise new issues ofsafety or effectiveness of the subject device.
Comparison of the Subject Device with the Predicate Device
	Subject Device	Predicate Device K172525	Remarks
FDA ProductCode	LZC	LZC	Same
FDAClassification	Class I	Class I	Same
Common Name	Medical Exam Glove	Medical Exam Glove	Same

Blue Non-Sterile Powder Free

Nitrile Examination Gloves Tested

for Use with ChemotherapyDrugs

Device Trade

Name

Halyard Lavender Nitrile Powder-

Free Exam Gloves Tested for Use

with ChemotherapyDrugs

Similar but different

color

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Indications forUse	The Halyard Lavender Powder-Free Nitrile Exam Glove is adisposable device intended formedical purposes that is worn onthe examiner's hand to preventcontamination between patient andexaminer. These gloves weretested for use with chemotherapydrugs listed on the label.	Non-Sterile Powder Free NitrileExamination Gloves Tested forUse with Chemotherapy Drugs isa disposable device intended formedical purposes that is worn onthe examiner's hand to preventcontamination between patientand examiner.	Same
TechnologicalCharacteristics	Lavender-colored, 9.5 inch, nitrile,powder-free, textured fingertip,ambidextrous, non-sterile patientexamination glove.	Technological characteristics anddesign meet ASTM D6319-10 andfollow the FDA's Medical GloveGuidance Manual.	Similar
		Performance Data
Standard	ResultsSubject Device	ResultsK172525	Remarks
ASTM D6978-05StandardPractice forAssessment ofResistance ofMedical Glovesto PermeationbyChemotherapyDrugs	No signs of breakthrough after 4hours for 10 drugs.Carmustine showed no signs ofbreakthrough until 0.3 minutes andThiotepa showed no signs ofbreakthrough until 30.9 minutes.Result: Meets acceptance criteria.• Cyclophosphamide (20.0 mg/ml) Nobreakthrough up to 240 minutes• Doxorubicin HCl (2.0 mg/ml) Nobreakthrough up to 240 minutes• Etoposide (20.0 mg/ml) Nobreakthrough up to 240 minutes• 5-Fluorouracil (50.0 mg/ml) Nobreakthrough up to 240 minutes• Paclitaxel (Taxol) (6.0 mg/ml) Nobreakthrough up to 240 minutes• Cisplatin (1.0 mg/ml) Nobreakthrough up to 240 minutes• Dacarbazine (10.0 mg/ml) Nobreakthrough up to 240 minutes• Ifosfamide (50.0 mg/ml) Nobreakthrough up to 240 minutes• Mitoxantrone (2.0 mg/ml) Nobreakthrough up to 240 minutes• Vincristine sulfate (1.0 mg/ml) Nobreakthrough up to 240 minutes• Carmustine (3.3 mg/ml) Nobreakthrough up to 0.3 minutes• ThioTEPA (10.0 mg.ml) Nobreakthrough up to 30.9 minutes	Results from the Permeation datafor the predicate device.• 5-Fluorouracil (50.0 mg/ml) Nobreakthrough up to 240 minutes• Etoposide (20.0 mg/ml) Nobreakthrough up to 240 minutes• Cyclophosphamide (20.0 mg/ml)No breakthrough up to 240 minutes• Carmustine (3.3 mg/ml) Nobreakthrough up to 12.4 minutes• ThioTEPA (10.0 mg.ml) Nobreakthrough up to 24.4 minutes• Paclitaxel (Taxol) (6.0 mg/ml) Nobreakthrough up to 240 minutes• Doxorubicin HCl (2.0 mg/ml) Nobreakthrough up to 240 minutes• Dacarbazine (10.0 mg/ml) Nobreakthrough up to 240 minutes• Cisplatin (1.0 mg/ml) Nobreakthrough up to 240 minutes• Ifosfamide (50.0 mg/ml) Nobreakthrough up to 240 minutes• Mitoxantrone (2.0 mg/ml) Nobreakthrough up to 240 minutes• Vincristine sulfate (1.0 mg/ml) Nobreakthrough up to 240 minutes	Similar

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ASTM D5151-06Standard TestMethod forDetection ofHoles in MedicalGloves	Testing of the subject deviceshows it meets the 2.5% AQLrequirement in the standards forleakage with an actual AQL of1.0%.	Testing results from thePredicate device:In accordance with ASTM D5151-06, following ASTM D6319 AQL2.5/Inspection Level G-I	Similar
ASTM D6124-06Standard TestMethod forResidualPowder onMedical Gloves	Residual powder on the subjectdevice is an average of 0.04mg/glove within the powder-freelimit of < 2 mg maximum powderper glove and meets theacceptance criteria for powder-free.	Residual Powder on the predicatedevice is a max of 0.52 mg perglove within the powder-free limitof < 2 mg maximum powder perglove and meets the acceptancecriteria for powder-free	Similar

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ASTM D6319-10StandardSpecification forNitrileExaminationGloves forMedicalApplications	The physical dimensions of thesubject device is within the limits ofthe standard and the physicalproperties of the subject devicemeet the requirements for tensilestrength with an average beforeaging of 30.56 MPa and afteraging of 37.53 MPa and elongationof 593% before aging and 533%after aging.	The physical dimensions of thesubject device is within the limitsof the standard and the physicalproperties of the subject devicemeet the requirements for tensilestrength with an average beforeaging of 15 MPa and after agingof 14 MPa and elongation of500% before aging and 400%after aging.	Similar
Biologicalevaluation ofmedical devices –Part 10: Test forirritation and skinsensitization	Under the conditions of the studythe subject device extracts (polarand non-polar) were not found tocause a sensitizing response or anirritation response in the animalmodel.	Under the conditions of the studythe predicate device extracts(polar and non-polar) were notfound to cause a sensitizingresponse or an irritation responsein the animal model.	Same
Biologicalevaluation ofmedical devices –Part 11: Tests forSystemic Toxicity	Under the condition of the study thesubject device extracts (polar andnon-polar) were not found to caus ea systemic response in the animalmodel	Data not available frommanufacturer	Different
Conclusion:	Performance data support the conclusion that the subject device is as safe, aseffective, and performs as well as the legally marketed device that wassubmitted and cleared under K172525.

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.