A powder-free sterile surgeon's glove is a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Device Description

The proposed device is a disposable device intended for over the counter use and is provided powder-free and sterile. The glove is made with natural rubber latex and is cream in color. The glove is manufactured using molds that feature independent thumb and tapered mechanically locking cuffs to help reduce cuff roll down.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the Protexis™ Latex Basic, Sterile Latex Powder-Free Surgical Gloves (Cream), based on the provided text:

Acceptance Criteria and Device Performance

The device is a modified version of an already cleared predicate device (K120934). The primary modification is the removal of colorant from the glove formulation. The acceptance criteria and performance are based on meeting established industry standards for surgical gloves and demonstrating substantial equivalence to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic / Acceptance Criteria	Standard/Test/FDA Guidance	Reported Device Performance (Modified Device)
Material Composition	N/A (Comparative Characteristic)	Sterile Latex Powder-Free Surgical Gloves with Protein Content Label Claim of 50 µg/dm² or less (Cream)
Design	N/A (Comparative Characteristic)	Single Use, Sterile, Powder-free, Hand Specific, Independent Thumb, Beaded Cuff, Lubricated
Intended Use/Indications for Use	N/A (Comparative Characteristic)	Powder-Free Surgeon's Glove
Dimensions & Physical Properties	ASTM D3577	Meet requirements
Freedom from Holes (AQL)	21 CFR 800.20 & ASTM D3577 (Tested per ASTM D5151)	Meets requirements (acceptable results)
Powder Residual	ASTM D3577 (Tested per ASTM D6124)	Meets requirements of ≤2.0 mg/glove for "Powder-Free" designation. Results generated values < 2mg of residual powder per glove.
Protein Content	ASTM D5712, FDA Medical Glove Guidance Manual	Contains less than 50 µg/dm² of total water extractable protein per glove
Biocompatibility: Primary Skin Irritation	ISO 10993-10	Meets requirements
Biocompatibility: Guinea Pig Maximization (Sensitization)	ISO 10993-10	Meets requirements
Biocompatibility (General)	ISO 10993-1	Meets requirements

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

The provided document does not explicitly state the specific sample sizes used for each individual test (e.g., number of gloves tested for dimensions, holes, protein content). It refers to compliance with established ASTM and ISO standards, which would typically specify sampling plans.

The data provenance is non-clinical performance testing, conducted by the manufacturer, Cardinal Health, in the context of a 510(k) submission to demonstrate substantial equivalence to a predicate device. The document does not provide details on country of origin of the data beyond "Cardinal Health" as the applicant.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable as the device is a medical glove, and the "ground truth" is established by adherence to recognized performance standards (ASTM, ISO) and laboratory testing methodologies, not by expert interpretation of images or clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable. Adjudication methods are typically relevant for studies involving subjective human interpretation (e.g., clinical trials or diagnostic accuracy studies) to resolve disagreements among observers. For physical and chemical testing of a medical device like a glove, the results are typically quantitative measurements against defined criteria.

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:

This information is not applicable. An MRMC study is relevant for evaluating diagnostic imaging or AI-assisted diagnostic tools. This submission pertains to surgical gloves, which do not involve human readers interpreting cases or AI assistance.

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

This information is not applicable. This is not an AI-based device.

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

The "ground truth" for the device's performance is based on objective measurements and results from standardized laboratory tests that demonstrate compliance with national and international standards (ASTM D3577, 21 CFR 800.20, ASTM D5151, ASTM D6124, ASTM D5712, ISO 10993-1, ISO 10993-10). The predicate device's prior clearance serves as the benchmark for substantial equivalence.

8. The sample size for the training set:

This information is not applicable. This is not a machine learning or AI-driven device, so there is no "training set." The device is manufactured according to specifications and tested against standards.

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

This information is not applicable as there is no training set for this device.

Summary

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K121897

JUL 2 7 2012

Cardinal Health

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

PROTEXIS™ LATEX BASIC, STERILE LATEX POWDER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABEL CLAIM OF 50µg/dm2 OR LESS (CREAM)

(A summary of safety and effectiveness information in accordance with the requirements of 21 CFR 807.92)

Applicant:

Cardinal Health 1430 Waukegan Road McGaw Park, IL 60085

Establishment Registration
Number:	1423537
Regulatory Affairs
Contact:	Tatyana Bogdan, RAC
Telephone:	847-887-2325
Fax:	847-887-2717
E-mail:	tatyana.bogdan-curvin@cardinalhealth.com

Summary Prepared: June 14, 2012

Protexis™ Latex Basic, Sterile Latex Powder-Free Surgical Glove with Trade Name: Protein Content Label Claim of 50ug/dm2 or less (Cream)

Common Name: Surgeon's Gloves

Classification Name: Surgeon's Gloves

Classification Panel: General and Plastic Surgery

21 CFR 878.4460 Regulation:

Product Code(s): KGO

Legally marketed device(s)

to which equivalence Protexis™ Latex Basic, Sterile Latex Powder-Free Surgical Gloves with Protein Content Label Claim of 50ug/dm2 or less (Tan) (510(k) K120934, product code KGO)

Reason for 510(k) Submission:

Device modification to remove colorant from glove formulation.

Device Description:

Device Description: The proposed device is a disposable device intended for over the counter use and is provided powder-free and sterile. The glove is made with natural rubber latex and is cream in color. The glove is manufactured using molds that feature independent thumb and tapered mechanically locking cuffs to help reduce cuff roll down.

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Intended Use:

This powder-free surgeon's glove is a disposable device made of natural This powater 1100 be worn by operating room personnel to protect a surgical wound from contamination.

Summary of the technological characteristics of the device compared to the predicate device
Characteristic	Modified Device	Original device (Predicate device cleared under K120934)
Material Composition	Sterile Latex Powder-Free Surgical Gloves with Protein Content LabelClaim of 50 µg/dm² or less (Cream)	Sterile Latex Powder-Free Surgical Gloves with Protein Content LabelClaim of 50 µg/dm² or less (Tan)
Material Composition	Natural Rubber Latex	Natural Rubber Latex
Design	Single UseSterilePowder-freeHand SpecificIndependent ThumbBeaded CuffLubricated	Single UseSterilePowder-freeHand SpecificIndependent ThumbBeaded CuffLubricated
Intended Use/Indications for Use	Powder-Free Surgeon's Glove	Powder-Free Surgeon's Glove
Dimensions &Physical Properties	Meets ASTM D3577	Meets ASTM D3577
Freedom from Holes	AQL meets 21CFR 800.20 & ASTM D3577 requirements	AQL meets 21CFR 800.20 & ASTM D3577 requirements
Powder Residual	Meets requirements of ≤2.0 mg/glove for Powder-Free designation per ASTM D3577	Meets requirements of ≤2.0 mg/glove for Powder-Free designation per ASTM D3577
Protein Contents	Contains less than 50 µg/dm² of total water extractable protein per glove as tested per ASTM D5712	Contains less than 50 µg/dm² of total water extractable protein per glove as tested per ASTM D5712
PERFORMANCE DATA
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OFSUBSTANTIAL EQUIVALENCE*
Performance Test Summary-New Device
Characteristic	Standard/Test/FDA Guidance	Results Summary
Biocompatibility:Primary Skin Irritation	ISO 10993-10	Meet requirements
Guinea Pig Maximization	ISO 10993-10	Meet requirements
Physical Characteristics:

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Dimensions	ASTM D3577		Meet requirements
Physical Properties	ASTM D3577		Meet requirements for rubber surgical gloves
Freedom from Holes	21 CFR 800.20 &		Tested in accordance with ASTM D5151 with
	ASTM D3577		acceptable results
Powder Residual	ASTM D3577 tested		Gloves meet powder level requirements for
	using ASTM standard		"Powder-Free" designation per ASTM
	D6124			D3577. Results generated values < 2mg of
			residual powder per glove.
Protein Content	ASTM D5712, FDA		Gloves yielded the results of less than 50
	Medical Glove			ug/dm2 of total water extractable protein per
	gloveGuidance Manual
Comparative Performance Information Summary
Characteristic	Requirement	Modified Device		Original Device
Biocompatibility:	ISO 10993-1	Meets requirements		Meets requirements
Primary Skin Irritation	ISO 10993-10	Meets requirements		Meets requirements
Guinea Pig	ISO 10993-10	Meets requirements		Meets requirements
Maximization
Dimensions	ASTM D3577	Meets requirements		Meets requirements
Physical Properties	ASTM D3577	Meets requirements		Meets requirements
Freedom from Holes	21CFR800.20,	Meets requirements		Meets requirements
	ASTM D3577
Powder Residual	ASTM D3577	Meets requirements		Meets requirements
Protein Content	ASTM D5712	Meets requirements		Meets requirements
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF
SURSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION

Clinical data is not required.

CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA

Non-clinical data demonstrates that Protexis™ Latex Basic, Sterile Latex Powder-Free Surgical Gloves with Protein Content Label Claim of less than 50 µg/dm² (Cream) meet the technological characteristics of ASTM D3577 standard, and are as safe, as effective, and performs as well as the legally marketed predicate devices identified in this summary.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

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

JUL 2 7 2012

Ms. Tatyana Bogdan-Curvin Regulatory Affairs Manager Cardinal Health, Incorporated 1430 Waukegan Road McGaw Park, Illinois 60085

Re: K121897
Trade/Device Name: Protexis™ Latex Basic, Sterile Latex Powder-Free Surgical Gloves with Protein Content Label Claim of 50 ug/dm2 or less (Cream) Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: May 14, 2012 Received: June 29, 2012

Dear Ms. Bogdan-Curvin:

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 ffor 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-Curvin

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

For Stetson

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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Image /page/5/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 that converge at a central point, resembling a bird in flight or a stylized medical symbol. The text "CardinalHealth" is written in a bold, sans-serif font, with the two words joined together.

Indications for Use

K121897

510(k) Number (if known):

Device Name:

Protexis™ Latex Basic, Sterile Latex Powder-Free Surgical Gloves with Protein Content Label Claim of 50 ug/dm2 or less (Cream)

Indications for Use:

A powder-free sterile surgeon's glove is a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

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 OF NEEDED)

Edi.let S. Lamino- I.V.V.

(Division Sign-Off) oncurrence of CDRH, Office of Device Evaluation (ODE) Division of Anesthesiology, General Hospita Infection Control, Dental Devices

510(k) Number: 1 >18 9 / Page of

Cardinal Health, Inc. Premarket Notification Submission - Special 510(k)

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).