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.

Device Description

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

AI/ML Overview

This document describes the acceptance criteria and the studies performed for the Cardinal Health Nitrile Powder-Free Examination Gloves.

1. Table of Acceptance Criteria and Reported Device Performance:

Test Method (Acceptance Criteria)	Reported Device Performance
Biocompatibility:
Primary Skin Irritation (non-irritating)	Gloves are non-irritating.
Guinea Pig Maximization (no sensitization potential)	Gloves do not display any potential for sensitization.
Physical Characteristics:
Dimensions (meets ASTM D6319 requirements)	Gloves meet requirements of ASTM D6319.
Physical Characteristics per ASTM D6319	Gloves meet requirements for Nitrile examination gloves per ASTM D6319.
Freedom from Holes (meets 21 CFR 800.20 and ASTM D6319)	Gloves meet requirements of 21 CFR 800.20 and ASTM D6319.
Powder Residual (below 2mg/glove per ASTM D6319 & D6124)	Results generated values below 2mg of residual powder per glove, meeting powder level requirements for "Powder-Free" designation.
Chemotherapy Permeation (ASTM D6978):	Break-through detection time (minimum 0.01 µg/cm²/minute)
Carmustine (BCNU) (3.3 mg/ml)	7.28 minutes
Cisplastin (1.0mg/ml)	>240 minutes
Cyclophosphamide (20 mg/ml)	>240 minutes
Doxorubicin HCl (2.0 mg/ml)	>240 minutes
Etoposide (Toposar) (20 mg/ml)	>240 minutes
5-Fluorouracil (50 mg/ml)	>240 minutes
Methotrexate (25 mg/ml)	>240 minutes
Paclitaxel (Taxol) (6.0 mg/ml)	>240 minutes
Thiotepa (10 mg/ml)	2.67 minutes

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

The document does not explicitly state the exact sample sizes for each specific test (e.g., number of gloves tested for physical characteristics, number of samples per drug for chemotherapy permeation).
However, the tests were conducted in accordance with established ASTM (American Society for Testing and Materials) standards (D6319, D6124, D6978) and 21 CFR 800.20. These standards typically define the appropriate sample sizes for such tests to ensure statistical validity.
The data provenance is not explicitly stated as "country of origin" but implies the studies were conducted to US regulatory standards (FDA 510(k) submission). The data is retrospective as it was gathered to support a premarket notification.

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 device. The "ground truth" for examination gloves is established through objective, standardized physical and chemical laboratory tests, not through expert consensus on interpretations of data or images. For example, chemical permeation is measured directly, not adjudicated by an expert.

4. Adjudication Method for the Test Set:

Not applicable. The tests involve objective measurements against predefined standards and thresholds, not subjective evaluations requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic medical devices where human interpretation of images/data is a factor, often with AI assistance. Examination gloves do not involve such a human-in-the-loop diagnostic process.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

Not applicable. This device is an examination glove, not an algorithm or AI system. Its performance is entirely "standalone" in the sense that it is a physical product designed to meet certain performance specifications through laboratory testing.

7. The Type of Ground Truth Used:

The ground truth used for this device is based on objective, standardized laboratory measurements and performance specifications. These include:
- Physical properties: such as dimensions, tensile strength, elongation, and freedom from holes, measured against the requirements of ASTM D6319 and 21 CFR 800.20.
- Biocompatibility properties: such as primary skin irritation and sensitization, assessed through established animal testing protocols.
- Chemical permeation resistance: measured experimentally using ASTM D6978 to determine breakthrough times for chemotherapy drugs.
- Residual powder levels: measured using ASTM D6124.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a "training set." Its effectiveness is proven through direct physical and chemical testing of manufactured gloves.

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

Not applicable, as no training set was used for this device.

Summary

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K103249

Image /page/0/Picture/1 description: The image shows the logo for Cardinal Health. The logo consists of a stylized graphic of three curved lines above the company name. The text "CardinalHealth" is written in a bold, sans-serif font.

DEC 16 2010

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

NITRILE POWDER-FREE EXAMINATION GLOVES

YTY Industry (Manjung) Sdn. Bhd. Manufacturer: Lot 1422 - 1424, Batu 10 Lekir, 32020 Sitiawan, Perak Darul Ridzuan, Malaysia

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

847-887-2325 Telephone:

October 11, 2010 Date Summary Prepared:
Stretchy Nitrile Cornflower Blue Powder-Free Exam Gloves with Product Trade Name: Tested for Use with Chemotherapy Drug Labeling Claim
Exam Gloves Common Name:
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 nonsterile. Gloves are comflower blue in color. Gloves are not made with 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)	7.28
2.	Cisplastin, (1.0mg/ml)	>240
3.	Cyclophosphamide (20 mg/ml)	>240
4.	Doxorubicin HCI (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)	2.67

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:

These Nitrile powder-free examination 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.

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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 Stretchy Nitrile Powder-Free Exam 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

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

Cardinal Health, Incorporated C/O Ms. Tatyana Bogdan Responsible Third Party Official Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062

DEC 16 2010

Re: K103249

Trade/Device Name: Nitrile Comflower Blue Powder-Free Exam Gloves tested for use with Chemotherapy Drugs Labeling Claim . Regulation Number: 21 CFR 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZA Dated: December 10, 2010 Received: December 13, 2010

Dear Ms. Bogdan:

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. Bogdan

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/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.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.

Jams Jizdado
for

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 ·

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050 16 2013

Indications for Use

510(k) Number (if known): K1032 49

Nitrile Comflower Blue Powder-Free Exam Gloves WiTH TESTED for Device Name: USE with Chemotherary Drugs Labeling Claim

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)	7.28
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)	2.67

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)

Elight D-Clawro Well

Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off)

Division of Anesthesiology, General Hospital

Infection Control, Dental Devices

Page __ of __
510(k) Number:	K103249

Cardinal Health, Inc.

Premarket Notification Submission - Traditional 510(k)

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.