These gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination in environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive as well as non-invasive medical procedures requiring sterility.

Device Description

Esteem Sterile Polyisoprene Surgical Gloves with Coating are formulated using Synthetic Rubber Latex. These are offered powder-free and sterile.

AI/ML Overview

This document pertains to the 510(k) summary of safety and effectiveness for the Esteem Sterile Polyisoprene Surgical Gloves with Coating. The information provided focuses on the physical and biological characteristics of the gloves, and therefore, many of the requested criteria regarding AI/algorithm performance are not applicable.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Test)	Reported Device Performance
Primary Skin Irritation	Gloves are non-irritating.
Guinea Pig Maximization (Sensitization)	Gloves do not display any potential for sensitization.
Ultimate Elongation & Tensile Strength	Gloves exceed requirements for rubber surgical gloves per ASTM D3577-01.
Barrier Defects	Gloves exceed requirements per 21 CFR §800.20 and ASTM D3577-01, AQL = 1.5.
Residual Powder Level	Gloves meet powder level requirements ("Powder Free" designation) using ASTM Standard D6124-00; results below 2 mg of residual powder per glove.

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

The document does not specify the exact sample sizes used for each test (e.g., number of gloves tested for barrier defects, number of animals for skin irritation/sensitization). The provenance of the data (country of origin, retrospective/prospective) is also not explicitly stated, but it can be inferred that these are standard laboratory tests conducted by the manufacturer, Cardinal Health, likely in the US where the 510(k) application was made.

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 the evaluation of surgical gloves. The "ground truth" for these tests is based on established scientific and regulatory standards (e.g., ASTM standards, CFR regulations) and laboratory measurements, not expert consensus on interpretations.

4. Adjudication method for the test set

Not applicable. The tests involve objective measurements against predefined standards. There is no mention of adjudication in the context of interpretation or consensus building.

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

Not applicable. This device is a physical medical device (surgical gloves), not an AI or imaging-based diagnostic tool. Therefore, MRMC studies and AI-related performance metrics are irrelevant.

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

Not applicable. This is not an algorithm or software device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for the performance of these surgical gloves is based on:

Established Industry Standards: ASTM International (e.g., D3577-01 for rubber surgical gloves, D6124-00 for residual powder).
Regulatory Requirements: 21 CFR §800.20 related to barrier defects.
Biological Testing Standards: Methods for evaluating skin irritation and sensitization (e.g., Guinea Pig Maximization Test).
These are objective, measurable criteria, not subjective expert consensus, pathology, or outcomes data in the typical sense for diagnostic devices.

8. The sample size for the training set

Not applicable. There is no machine learning or AI component that would require a training set.

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

Not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Cardinal Health. The logo consists of the words "CardinalHealth" in a simple, sans-serif font. Above the text, there is a graphic element that appears to be a stylized representation of a bird in flight or a series of abstract lines.

OCT 1 5 2003

XIII. SUMMARY OF SAFETY AND EFFECTIVENESS

K031301

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING '

Regulatory Affairs Contact:	Erica SethiCardinal Health1500 Waukegan Road, MP-WMMcGaw Park, IL 60085
Telephone:	(847) 785-3337
Date Summary Prepared:	4/7/03
Product Trade Name:	Undetermined
Common Name:	Surgical Glove
Classification:	Glove, Surgeon's
Predicate Devices:	Esteem Sterile Polyisoprene Surgical Gloves
Description:	Esteem Sterile Polyisoprene Surgical Gloves with Coating areformulated using Synthetic Rubber Latex. These are offeredpowder-free and sterile.
Intended Use:	Esteem Sterile Polyisoprene Surgical Gloves with Coating areintended for use in environments within hospitals and otherhealthcare facilities. The gloves are appropriate for use duringinvasive and non-invasive medical procedures requiringsterility. They are intended to be worn by operating roompersonnel to protect a surgical wound from contamination.

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K031301

Page 2

Substantial Equivalence:	Esteem Sterile Polyisoprene Surgical Gloves with Coating aresubstantially equivalent to Esteem Sterile Polyisoprene SurgicalGloves in that they provide the following characteristics:- same intended use- same sizes, product features, packaging- both made of Synthetic Rubber Latex using similar manufacturingprocess
Summary of Testing:
Test	Result
Primary Skin Irritation	Gloves are non-irritating.
Guinea Pig Maximization	Gloves do not display any potential for sensitization.
Ultimate Elongation& Tensile Strength	Gloves exceed requirements for rubber surgical glovesper ASTM D3577-01.
Barrier Defects	Gloves exceed requirements per 21 CFR§800.20 and ASTM D3577-01, AQL = 1.5.
Data/Test Method	Gloves meet powder level requirements for "Powder Free"designation using ASTM Standard D6124-00-Standard test methodfor residual powder on medical gloves. Results generated valuesbelow 2 mg of residual powder per glove.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 5 2003

Ms. Erica Sethi Manager, Regulatory Affairs Cardinal Heath Medical Product and Services 1500 Waukegan Road Building WM Mcgaw Park, Illinois 60085

Re: K031301

Trade/Device Name: Esteem Sterile Polyisoprene Powder Free Surgical Gloves with Coating Regulation Number: 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: July 23, 2003 Received: July 24, 2003

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 (OS) 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 vour 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.

Clis

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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Image /page/4/Picture/0 description: The image shows the logo for Cardinal Health. The logo consists of a stylized bird-like graphic above the company name. The text "CardinalHealth" is written in a simple, sans-serif font, with the two words joined together.

1500 Waukegan Road McGaw Park. Illinois 60085-6787 847.473.1500 FAX: 847.785.2460

Page 1 of 1

Applicant:	Cardinal Health
510(k) Number:	KO31301
Device Name:	Esteem Sterile Polyisoprene Powder Free Surgical Gloves With Coating*
Indications For Use:	These gloves are intended to be worn by operating room personnel toprotect a surgical wound from contamination in environments withinhospitals and other healthcare facilities. The gloves are appropriatefor use during invasive as well as non-invasive medical proceduresrequiring sterility.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) Or

Over-The Counter Use

Patricia D. Anderson Branch Chief, 10/15/03

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

510(k) Number: KD31301

Regulation Number and Section

§ 878.4460 Non-powdered surgeon's glove.

(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).