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.

Device Description

Dental Powder-Free Latex Examination Gloves are formulated using natural rubber latex and offered non-sterile.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Dental Powder-Free Latex Examination Gloves with Protein Labeling Claim, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implicit)	Reported Device Performance
Primary Skin Irritation	No potential for irritation	Gloves do not display any potential for irritation.
Guinea Pig Maximization (Sensitization)	No potential for sensitization	Gloves do not display any potential for irritation.
Ultimate Elongation & Tensile Strength	Meet or exceed requirements per ASTM D3578-01	Gloves meet or exceed requirements for rubber examination gloves per ASTM D3578-01.
Barrier Defects	Meet or exceed requirements per 21 CFR §800.20 and ASTM D3578-01	Gloves meet or exceed requirements per 21 CFR §800.20 and ASTM D3578-01.

Note: The acceptance criteria for "Primary Skin Irritation" and "Guinea Pig Maximization" are implicitly derived from the reported results, as the document states the gloves "do not display any potential for irritation" (which, for Guinea Pig Maximization, typically implies no sensitization).

Regarding the device and study described, it's important to note the following based on the provided text:

This submission is for a medical device (examination gloves), not a diagnostic AI/imaging algorithm. Therefore, many of the requested categories related to AI studies, like MRMC studies, ground truth establishment by experts, and training/test set details, are not applicable to this type of device. The "study" here refers to standard performance testing for a physical product.

Here's an attempt to address the remaining points as best as possible given the nature of the device:

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

Sample Size: Not explicitly stated in the provided text for any of the tests. Standard ASTM and regulatory testing typically involves specific sample sizes, but these are not disclosed here.
Data Provenance: Not explicitly stated. For physical product testing, this typically means the samples were manufactured and then tested according to established protocols. It is assumed to be prospective, as the testing was done on the device prior to marketing approval.

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

Not Applicable. For physical product testing like gloves, "ground truth" is established through standardized laboratory tests (e.g., measuring tensile strength using a machine, or observing skin reactions in animal models), not by human experts interpreting data.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of data (e.g., medical images). For physical product testing, results are objective measurements or observations during laboratory procedures.

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. This is not an AI-assisted diagnostic device, so an MRMC study is not relevant.

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

Not Applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

For Ultimate Elongation & Tensile Strength and Barrier Defects: The "ground truth" is based on the objective physical and chemical properties of the glove as measured by standardized industrial and regulatory test methods (ASTM D3578-01, 21 CFR §800.20).
For Primary Skin Irritation and Guinea Pig Maximization: The "ground truth" is based on the biological response of test subjects (e.g., animals for sensitization, human volunteers for irritation if not animal-based) under controlled laboratory conditions.

8. The Sample Size for the Training Set

Not Applicable. This is a physical device, not an AI model, so there is no "training set."

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

Not Applicable. There is no training set for this type of device.

Summary

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XIII. SUMMARY OF SAFETY AND EFFECTIVENESS

Allegiance

K024102

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM

Manufacturer: Allegiance Healthcare Corporation 1500 Waukegan road McGaw Park, IL 60085

Regulatory Affairs Contact: Erica Sethi Allegiance Healthcare Corporation 1500 Waukegan Road, Bldg. K McGaw Park, IL 60085

Telephone: (847) 785-3337

Date Summary Prepared: 11/20/02

Product Trade Name: Undetermined

Common Name: Examination Glove

Classification: Patient Examination Glove

Predicate Devices: Dental Latex Powdered Examination Gloves

Description: Dental Powder-Free Latex Examination Gloves are formulated using natural rubber latex and offered non-sterile.

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. These Dental Latex Examination Gloves are intended specifically for Dentistry and will be worn during dental cleaning, filling and examination in non-sterile environments within hospitals and other healthcare facilities.

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Substantial Equivalence: The Dental Powder-Free Latex Examination Gloves With Protein Labeling Claim are substantially equivalent to Dental Latex Powdered Examination Gloves in that they provide the following characteristics:

same intended use
same sizes, configuration, packaging
both made of natural rubber latex
same tensile strength and thickness profiles
both hand specific non-sterile examination gloves

Summary of Testing:

Test	Result
Primary Skin Irritation	Gloves do not display any potential for irritation.
Guinea Pig Maximization	Gloves do not display any potential for irritation.
Ultimate Elongation& Tensile Strength	Gloves meet or exceed requirements for rubber examinationgloves per ASTM D3578-01.
Barrier Defects	Gloves meet or exceed requirements per 21 CFR§800.20 and ASTM D 3578-01.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle image.

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

Ms. Erica Sethi Regulatory Affairs Allegiance Healthcare Corporation 1500 Waukegan Road, Building K McGraw Park, Illinois 60085

Re: K024102

Trade/Device Name: Dental Powder-Free Latex Examination Gloves with Protein Labeling Claim Regulation Number: 880.6250 Regulation Name: Patient Examination Gloves Regulatory Class: I Product Code: LYY Dated: November 20, 2002 Received: December 12, 2002

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 vour 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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Susan Larson

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Allegiance

Allegiance Healthcare Corporation
1500 Waukegan Road
McGaw Park, Illinois 60085-6787
847.473.1500
FAX: 847.785.2460

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Applicant:

Allegiance Healthcare Corporation

510(k) Number:

Device Name:

Dental Powder-Free Latex Examination Gloves With Protein 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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The Counter Use

Clins S. Com

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

510(k) Number K024102

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.