A 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 are worn to protect the wearer against exposure to chemotherapy drugs.

Device Description

Latex Powder-Free Examination Glove with tan color, proprietary coating (containing Provitamin B, Gluconolactone and Glycerol), protein labeling claim and chemotherapy labeling claim are formulated using Latex and offered powder-free.

AI/ML Overview

The provided text describes the 510(k) summary for a Latex Powder-Free Examination Glove. It details the product, its intended use, and a summary of testing conducted to demonstrate substantial equivalence to predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided input:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implicit)	Reported Device Performance
Primary Skin Irritation	No irritation potential	Gloves show no irritation.
Guinea Pig Maximization	No sensitization potential	Gloves do not display any potential for irritation (likely implying no sensitization).
Tensile Strength	Meet or exceed requirements per ASTM D3578-01ae2	Gloves meet or exceed requirements per ASTM D3578-01ae2.
Barrier Defects	Meet or exceed requirements per 21 CFR§800.20 and ASTM D3578-01ae2	Gloves meet or exceed requirements per 21 CFR§800.20 and ASTM D3578-01ae2.
Chemotherapy testing	Pass specified chemotherapy drug permeation testing	Tested for chemotherapy drugs using ASTM F739-99a (implies passing, as per substantial equivalence claim).

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes used for any of the tests. It only lists the tests performed and their results. The data provenance (e.g., country of origin, retrospective/prospective) is also not provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to this type of device and study. The "ground truth" for examination gloves is established through objective physical and chemical testing against established standards (ASTM, CFR). It does not involve expert consensus in the way medical imaging or CAD systems would.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or subjective assessment. The tests described are objective laboratory tests.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools, not for medical examination gloves. The document describes a traditional 510(k) submission based on equivalence to predicate devices and adherence to performance standards.

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

This question is not applicable as the device is an examination glove, not an algorithm or AI system. The tests performed are standalone in the sense that they are laboratory tests on the glove itself, not involving human interpretation or AI.

7. The type of ground truth used

The ground truth for this device is based on:

Established engineering and chemical standards: ASTM D3578-01ae2 for physical properties (tensile strength, barrier defects) and ASTM F739-99a for chemotherapy permeation.
Regulatory requirements: 21 CFR§800.20 for barrier defects.
Biological safety assessments: Primary skin irritation and Guinea Pig Maximization for irritation and sensitization potential, assessed against accepted toxicological paradigms.

8. The sample size for the training set

This information is not applicable. There is no "training set" for a physical device like an examination glove in the context of an algorithm or AI. The substantial equivalence claim is based on manufacturing processes and performance testing against established standards, not machine learning.

9. How the ground truth for the training set was established

This information is not applicable for the same reasons as point 8.

Summary

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MAY - 7 2004

Image /page/0/Picture/1 description: The image shows the logo for Cardinal Health. The logo consists of a stylized bird-like design above the company name. The bird design is made up of several curved lines that converge to a point, and the company name is written in a bold, sans-serif font.

XIII. SUMMARY OF SAFETY AND EFFE

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Latex Powder-Free Examination Glove with tan color, proprietary coating (containing Provitamin B, Gluconolactone and Glycerol), protein labeling claim and chemotherapy labeling claim

Applicant/Sponsor: Cardinal Health 1500 Waukegan Road McGaw Park, IL 60085

Regulatory Affairs Contact: Erica Sethi Cardinal Health 1500 Waukegan Road, Bldg, WM McGaw Park, IL 60085

Telephone: (847) 785-3337

Date Summary Prepared: 5/4/04

Product Trade Name: Undetermined

Common Name: Examination Glove

Classification: Patient Examination Glove

Predicate Devices: Latex Powder-Free Examination Gloves

Description: Latex Powder-Free Examination Glove with tan color, proprietary coating (containing Provitamin B, Gluconolactone and Glycerol), protein labeling claim and chemotherapy labeling claim are formulated using Latex and offered powder-free.

Intended Use: These examination gloves are disposable devices intended for medical purposes that are worn on the examiner's hands or fingers to prevent contamination between patient and examiner. In addition, these gloves are worn to protect the wearer against exposure to chemotherapy drugs. These latex gloves contain 50 micrograms or less of total water extractable protein per gram.

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Substantial Equivalence: Latex Powder-Free Examination Glove with tan color, proprietary coating (containing Provitamin B, Gluconolactone and Glycerol), protein labeling claim and chemotherapy labeling claim are substantially equivalent to Cardinal Health's Latex Powder-Free Examination Gloves in that they provide the following characteristics:

same intended use
both made of Latex
both offered beaded and powder-free

Summary of Testing:

Test	Result
Primary Skin Irritation	Gloves show no irritation.
Guinea Pig Maximization	Gloves do not display any potential for irritation.
Tensile Strength	Gloves meet or exceed requirements per ASTM D3578-01ae2.
Barrier Defects	Gloves meet or exceed requirements per 21 CFR§800.20and ASTM D3578-01ae2.
Chemotherapy testing	Tested for chemotherapy drugs using ASTM F739-99a

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Image /page/2/Picture/1 description: The image is a black and white circular logo. The logo features the emblem of the U.S. Department of Health and Human Services. The emblem consists of a stylized eagle with three lines representing its wings, positioned within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY = 7 2004

Cardinal Health Ms. Erica Sethi Manager, Regulatory Affairs Medial Product and Services 1500 Waukegan Road Building WM McGaw Park, Illinois 60085-6787

Re: K033789

Trade/Device Name: Latex Powder-Free Examination Glove with Tan Color, Proprietary Coating (Containing Provitamin B, Gluconolactone and Glycerol), Protein Labeling Claim and Chemotherapy Labeling Claim Regulation Number: 880.6250 Regulation Name: Patient Examination Glove Regulatory Class: I Product Code: LZC Dated: April 8, 2004 Received: April 9, 2004

Dear Ms. Sethi:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Sethi

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Chiu Lin, Ph.D.

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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Waukedan Road

Rem Mucey

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number_ K 033789

Page 1 of 1

Applicant:

Cardinal Health

510(k) Number:

<033789

Device Name: Latex Powder-Free Examination Glove with tan color, proprietary coating (containing Provitamin B, Gluconolactone and Glycerol), protein labeling claim and chemotherapy labeling claim

Indications For Use: A 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 are worn to protect the wearer against exposure to chemotherapy drugs.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The Counter Use X

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.