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. These gloves are appropriate for use during invasive as well as non-invasive medical procedures requiring sterility.

Device Description

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

AI/ML Overview

This document describes acceptance criteria and testing for the Esteem Blue Polyisoprene Surgical Gloves with Coating.

1. Table of Acceptance Criteria and Reported Device Performance:

Test/Characteristic	Acceptance Criteria (Set by Regulations/Standards)	Reported Device Performance
Primary Skin Irritation	Not explicitly stated in the provided text, but implied as "non-irritating" for safe use.	Gloves are non-irritating.
Guinea Pig Maximization	Not explicitly stated in the provided text, but implied as not causing sensitization for safe use.	Gloves do not display any potential for sensitization.
Ultimate Elongation & Tensile Strength	Exceed requirements for rubber surgical gloves per ASTM D3577-01a2.	Gloves exceed requirements for rubber surgical gloves per ASTM D3577-01a2.
Barrier Defects	Exceed requirements per 21 CFR §800.20 and ASTM D3577-01a2, with an Acceptance Quality Limit (AQL) of 1.5.	Gloves exceed requirements per 21 CFR §800.20 and ASTM D3577-01a2, AQL = 1.5.
Powder Level	Meet powder level requirements for "Powder Free" designation using ASTM Standard D6124-01 (implied < 2 mg per glove).	Gloves meet powder level requirements for "Powder Free" designation using ASTM Standard D6124-01-Standard test method for residual powder on medical gloves. Results generated values below 2 mg of residual powder per glove. (This is the specific numerical acceptance criteria).

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is detailed in the "Summary of Testing" section of the 510(k) submission. It consists of multiple tests performed on the Esteem Blue Polyisoprene Surgical Gloves with Coating.

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

Sample Size: The provided document does not explicitly state the specific sample sizes used for each individual test (e.g., number of gloves tested for barrier defects, number of guinea pigs for sensitization). It reports the results of these tests against established standards.
Data Provenance: The data is likely prospective as these tests are part of a premarket notification (510(k)) process, meaning they were conducted specifically to demonstrate the safety and effectiveness of this new device before it entered the market. The country of origin of the data is not specified, but the submission is for the USA FDA, implying the tests were conducted according to US regulatory standards, which usually means within or for a US-based submission.

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

Not applicable. This document pertains to the performance testing of a physical medical device (surgical gloves) against established engineering and biological standards, not diagnostic device performance requiring expert-derived ground truth. The "ground truth" here is objective measurement against specified criteria in standards like ASTM and CFR.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, this relates to objective physical and biological testing, not diagnostic assessments requiring consensus or adjudication among experts. The results are based on direct measurements and observations compared to pre-defined thresholds within the specified standards.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices or AI-assisted diagnostic tools to assess how human readers' performance (e.g., accuracy, efficiency) is affected by the AI. This document concerns the physical and biological properties of surgical gloves, which do not involve human readers interpreting cases.

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

Not applicable. This is not an AI/algorithm-based device. The "standalone" performance refers to the intrinsic physical and biological qualities of the glove itself.

7. The Type of Ground Truth Used:

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

Established Regulatory Standards: For barrier defects (21 CFR §800.20).
Consensus Industry Standards: For ultimate elongation & tensile strength (ASTM D3577-01a2), barrier defects (ASTM D3577-01a2), and powder level (ASTM D6124-01).
Standardized Biological Safety Tests: For primary skin irritation and guinea pig maximization, where "non-irritating" and "no sensitization potential" are the accepted outcomes.

These standards define the objective and measurable criteria that the device must meet.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not a machine learning model. Therefore, 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 a machine learning model, there is no ground truth to establish for such a set.

Summary

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

K042574

DEC - 8 2004

XIII. SUMMARY OF SAFETY AND EFFECTIVENESS

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS ESTEEM BLUE POLYISOPRENE SURGICAL GLOVES WITH COATING (CONTAINING CHITOSAN, PROVITAMIN B, GLUCONOLACTONE AND GLYCEROL)

Regulatory Affairs Contact:	Erica SethiCardinal Health1500 Waukegan Road, MP-WMMcGaw Park, IL 60085
Telephone:	(847) 785-3337
Fax:	(847)785-2461
Date Summary Prepared:	9/13/04
Product Trade Name:	Undetermined
Common Name:	Surgical Glove
Classification:	Glove, Surgeon's
Predicate Devices:	Cardinal Health's Esteem Sterile Polyisoprene SurgicalGloves (K011721)
Description:	Esteem Blue Polyisoprene Surgical Gloves with coating areformulated using Synthetic Rubber Latex. These are offeredpowder-free and sterile.
Intended Use:	Esteem Blue 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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Substantial Equivalence:	Esteem Blue 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 D3577-01a2.
Barrier Defects	Gloves exceed requirements per 21 CFR§800.20 and ASTM D3577-01a2, AQL = 1.5.
Data/Test Method	Gloves meet powder level requirements for "Powder Free"designation using ASTM Standard D6124-01-Standard test methodfor residual powder on medical gloves. Results generated valuesbelow 2 mg of residual powder per glove.

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DEPARTMENT OF HEALTH & HUMAN SERVICES - USA

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 8 2004

Cardinal Health C/O Mr. Ned Devine Responsible Third Party Official Entela, Incorporated 3033 Madison Avenue, SE Grand Rapids, Michigan 49548-1289

Re: K042574

Trade/Device Name: Esteem Blue Polyisoprene Surgical Glove with Coating (Containing Chitosan, ProvitaminB, Gluconolactone and Glycerol) Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: November 24, 2004 Received: November 26, 2004

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.

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 - 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); 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 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 (240) 276-0115. 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,

f Susan Tuono
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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Indications for Use

510(k) Number (if known): K042574

Esteem Blue Polyisoprene Surgical Glove with coating (containing Device Name: Chitosan, ProvitaminB, Gluconolactone and Glycerol). Indications For Use: 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. These gloves are appropriate for use during invasive as well as non-invasive medical procedures requiring sterility.

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)

Suptie Michie Cnd.

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

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510(k) Number. K042574

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).