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.

In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

	Chemotherapy Drug andConcentration	Minimum Breakthrough Detection Timein Minutes, 0.01 µg/cm²/minute
1.	Carmustine (BCNU) (3.3 mg/ml)	0.61
2.	Cisplastin, (1.0mg/ml)	>240
3.	Cyclophosphamide (20 mg/ml)	>240
4.	Doxorubicin HCl (2.0 mg/ml)	>240
5.	Etoposide (Toposar) (20 mg/ml)	>240
6.	5-Fluorouracil (50 mg/ml)	>240
7.	Methotrexate (25 mg/ml)	>240
8.	Paclitaxel (Taxol) (6.0 mg/ml)	>240
9.	Thiotepa (10 mg/ml)	10.6

The maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time of less than 30 minutes:

Carmustine (BCNU) (3.3 mg/ml) Thiotepa (10 mg/ml)

Device Description

These patient examination gloves are formulated using Nitrile. They are a disposable device that is offered powder-free and non-sterile. Gloves are cornflower blue in color. Gloves are not made with natural rubber latex.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Cardinal Health Nitrile Cornflower Blue Powder-Free Examination Gloves, structured according to your request.

This document describes a medical device, specifically examination gloves, and presents testing results, rather than an AI/ML powered device. As such, several of your requested points (like "effect size of how much human readers improve with AI vs without AI assistance", training set size, etc.) are not applicable to this type of submission. I will address the relevant points and indicate when information is not applicable.

Acceptance Criteria and Device Performance for Nitrile Cornflower Blue Powder-Free Examination Gloves

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Test	Standard/Requirement	Reported Device Performance
Primary Skin Irritation	Not explicitly stated, implied to be non-irritating for patient contact (standard practice for medical devices).	Gloves are non-irritating.
Guinea Pig Maximization (Sensitization Potential)	Not explicitly stated, implied to be non-sensitizing (standard practice for medical devices).	Gloves do not display any potential for sensitization.
Dimensions	ASTM D6319	Gloves meet requirements of ASTM D6319.
Physical Characteristics	ASTM D6319 (for Nitrile examination gloves)	Gloves meet requirements for Nitrile examination gloves per D6319.
Freedom from Holes	21 CFR 800.20 and ASTM D6319	Gloves meet requirements of 21 CFR 800.20 and ASTM D6319.
Powder Residual	ASTM D6319 (for "Powder-Free" designation) using ASTM D6124 test method	Results generated values below 2mg of residual powder per glove, meeting powder level requirements for "Powder-Free" designation per ASTM D6319.
Chemotherapy Permeation (Minimum Breakthrough Time)	ASTM D6978-05 (0.01 µg/cm²/minute detection limit, max testing time 240 minutes)	Carmustine (BCNU) (3.3 mg/ml): 0.61 minutesCisplatin (1.0mg/ml): >240 minutesCyclophosphamide (20 mg/ml): >240 minutesDoxorubicin HCl (2.0 mg/ml): >240 minutesEtoposide (Toposar) (20 mg/ml): >240 minutes5-Fluorouracil (50 mg/ml): >240 minutesMethotrexate (25 mg/ml): >240 minutesPaclitaxel (Taxol) (6.0 mg/ml): >240 minutesThiotepa (10 mg/ml): 10.6 minutes

2. Sample Size for Test Set and Data Provenance

Sample Size: The document does not specify the exact sample size (number of gloves or test replicates) used for each individual test (e.g., skin irritation, dimensions, permeation). It states "Gloves meet requirements..." or "Results generated..." indicating that tests were performed to establish compliance.
Data Provenance: The document does not explicitly state the country of origin for the data or if it was retrospective or prospective. Given it's a 510(k) submission to the FDA, the testing was likely conducted in accordance with recognized international or US standards in accredited laboratories to support the submission.

3. Number of Experts and Qualifications for Ground Truth

Not Applicable. This is a physical product (gloves) undergoing standardized material and performance testing, not an AI/ML system requiring expert-established ground truth from medical images or clinical observations. The "ground truth" is established by the specifications of the ASTM standards and regulatory requirements.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in human-in-the-loop or expert-driven diagnostic studies, which is not relevant here. The results are based on objective measurements and compliance with specified test methods.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not Applicable. This type of study assesses the performance of AI systems in a clinical context, often with human readers. This submission is for a physical medical device (gloves) and does not involve AI or human readers for diagnostic purposes.

6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance)

Not Applicable. This is not an algorithm or software device. The "standalone performance" refers to the glove's physical and chemical resistance properties as measured against established standards.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is defined by established ASTM (American Society for Testing and Materials) standards and FDA regulations.
- For physical properties and freedom from holes, it's compliance with ASTM D6319 and 21 CFR 800.20.
- For powder residual, it's compliance with ASTM D6319 using ASTM D6124 methodology.
- For chemotherapy permeation, it's the breakthrough time as measured according to ASTM D6978-05.
- For biocompatibility (skin irritation and sensitization), it's the observed biological response as determined by standardized tests.

8. Sample Size for the Training Set

Not Applicable. This is not an AI/ML device, so there is no "training set."

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

Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

Summary of the Study Proving Device Meets Acceptance Criteria:

The device's performance was proven through a series of standardized laboratory tests detailed in the "Performance Testing" section. These tests were conducted according to recognized ASTM standards (D6319, D6124, D6978-05) and FDA regulations (21 CFR 800.20). The results consistently demonstrate that the Nitrile Cornflower Blue Powder-Free Examination Gloves meet all specified requirements for physical characteristics, freedom from holes, powder residual, primary skin irritation, potential for sensitization, and resistance to permeation by nine specific chemotherapy drugs. The specific "Minimum Breakthrough Detection Time" for each chemotherapy drug was measured to confirm its protective qualities. Based on this comprehensive testing, the manufacturer concluded that the gloves meet the technological characteristics of ASTM D6319 performance standard and are substantially equivalent to their predicate device.

Summary

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K110921

APR 1 5 2011

Page 1 of 3

Image /page/0/Picture/3 description: The image shows the logo for Cardinal Health. The logo consists of three curved lines above the company name. The company name is written in a bold, sans-serif font, with the word "Cardinal" in a slightly larger font size than the word "Health."

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

NITRILE CORNFLOWER BLUE POWDER-FREE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS

Applicant:	Cardinal Health, Inc.1430 Waukegan RoadMcGaw Park, IL 60085
Regulatory Affairs Contact:	Tatyana Bogdan, RAC

Telephone:	847-887-2325
Date Summary Prepared:	February 21, 2011
Product Trade Name:	Nitrile Powder-Free Exam Gloves Tested for Use withChemotherapy Drugs
Common Name:	Exam Gloves
Classification Name:	Patient Examination Gloves
Device Description:	These patient examination gloves are formulated using Nitrile.They are a disposable device that is offered powder-free and non-sterile. Gloves are cornflower blue in color. Gloves are not madewith natural rubber latex.

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Intended Use:

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.

In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

	Chemotherapy Drug andConcentration	Minimum Breakthrough Detection Timein Minutes, 0.01 µg/cm²/minute
1.	Carmustine (BCNU) (3.3 mg/ml)	0.61
2.	Cisplastin, (1.0mg/ml)	>240
3.	Cyclophosphamide (20 mg/ml)	>240
4.	Doxorubicin HCl (2.0 mg/ml)	>240
5.	Etoposide (Toposar) (20 mg/ml)	>240
6.	5-Fluorouracil (50 mg/ml)	>240
7.	Methotrexate (25 mg/ml)	>240
8.	Paclitaxel (Taxol) (6.0 mg/ml)	>240
9.	Thiotepa (10 mg/ml)	10.6

The maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time of less than 30 minutes:

Carmustine (BCNU) (3.3 mg/ml) Thiotepa (10 mg/ml)

Predicate Devices:

Nitrile Blue Powder-Free Examination Gloves with Tested for Use with Chemotherapy Drug Labeling Claim previously cleared under 510(k) K022765 (product code LZA);

Substantial Equivalence:

The gloves are substantially equivalent to the predicate device identified in this 510(k) summary. Substantial equivalence can be established in regard to intended use, physical characteristics, design and product features. Both gloves are made with Nitrile using similar manufacturing processes. In addition, both gloves have been tested for use with chemotherapy drugs.

Performance Testing:

Test:	Result:
Primary Skin Irritation	Gloves are non-irritating.
Guinea Pig Maximization	Gloves do not display any potential for sensitization.

Cardinal Health, Inc.

Premarket Notification Submission - Traditional 510(k)

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K110921

Pagealನ1	tಟ
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Dimensions	Gloves meet requirements of ASTM D6319.
Physical CharacteristicsASTM	Gloves meet requirements for Nitrile examination gloves perD6319.
Freedom from Holes	Gloves meet requirements of 21 CFR 800.20 and ASTM D6319
Powder Residual	Gloves meet powder level requirements for "Powder-Free"designation per ASTM D6319 tested using ASTM standardD6124, Standard test method for residual powder on medicalgloves. Results generated values below 2mg of residual powderper glove.
Chemotherapy Permeation	Gloves were tested using ASTM D6978, Standard Practice forAssessment of Resistance of Medical Gloves to Permeation byChemotherapy Drugs. The maximum testing time is 240 minutes.
Clinical Data:

No clinical data is required.

Conclusion:

The gloves meet the technological characteristics of ASTM D6319 performance standard and are substantially equivalent to the predicate device identified in this 510(k) summary.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with three wing-like shapes.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Cardinal Health, Incorporated C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories. Incorporated 333 Pfingsten Road Northbrook, Illinois 60062

APR 1 5 2011

Re: K110921

Trade/Device Name: Nitrile Cornflower Blue Powder-Free Exam Tested for Use with Chemotherapy Drugs (Non-Sterile) Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: March 30, 2011 Received: April 1, 2011

Dear Mr. Devine:

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- Mr. Devine

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ ucm 1 5809.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.fdagov/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.

Sincerely yours,

Elizabeth A. Laurie. Williams

Anthony D. Watson, B.S., M.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

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Indications for Use

510(k) Number (if known): K110921

Nitrile Cornflower Blue Powder-Free Exam Gloves Tested for Use with Device Name: Chemotherapy Drugs (Non-sterile)

Indications for Use: 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.

In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:

	Chemotherapy Drug andConcentration	Minimum Breakthrough Detection Timein Minutes, 0.01 µg/cm²/minute
1.	Carmustine (BCNU) (3.3 mg/ml)	0.61
2.	Cisplastin, (1.0mg/ml)	>240
3.	Cyclophosphamide (20 mg/ml)	>240
4.	Doxorubicin HCl (2.0 mg/ml)	>240
5.	Etoposide (Toposar) (20 mg/ml)	>240
6.	5-Fluorouracil (50 mg/ml)	>240
7.	Methotrexate (25 mg/ml)	>240
8.	Paclitaxel (Taxol) (6.0 mg/ml)	>240
9.	Thiotepa (10 mg/ml)	10.6

The maximum testing time is 240 minutes. Please note that the following drugs have extremely low permeation time of less than 30 minutes:

Carmustine (BCNU) (3.3 mg/ml) Thiotepa (10 mg/ml)

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X_ (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)

Cardinal Health, Inc.Premarket Notification Submission - Traditional 510(k)	(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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510(k) Number:	K110921	5
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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.