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. It is made with natural rubber latex and is tan 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

The provided text describes the acceptance criteria and performance of the Protexis™ Latex Basic, Sterile Latex Powder-Free Surgical Gloves. No study proving the device meets the acceptance criteria is detailed in the submission; rather, the document declares that the device meets existing standards and requirements.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Requirement (Acceptance Criteria)	Reported Device Performance (New Device)	Study/Test Method
Material Composition	Not explicitly stated as a separate requirement, but defined.	Protexis™ Latex Basic, Sterile Latex Powder-Free Surgical Gloves with Protein Content Label Claim of 50 µg/dm2 or less (Tan)	N/A
Design	Single Use, Sterile, Powder-free, Hand Specific, Independent Thumb, Beaded Cuff, Lubricated	Meets design requirements	N/A
Intended Use	Powder-Free Surgeon's Glove	Powder-Free Surgeon's Glove	N/A
Dimensions	Meets ASTM D3577	Meets requirements	ASTM D3577
Physical Properties	Meets ASTM D3577	Meets requirements	ASTM D3577
Freedom from Holes	AQL meets 21CFR 800.20 & ASTM D3577 requirements	Meets requirements	21CFR 800.20, ASTM D3577
Powder Residual	≤ 2.0 mg/glove for Powder-Free designation per ASTM D3577	Meets requirements	ASTM D3577 (tested using ASTM standard D6124)
Protein Content	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	ASTM D5712, FDA Medical Glove Guidance Manual
Biocompatibility	ISO 10993-1	Meets requirements	ISO 10993-1, ISO 10993-10
Primary Skin Irritation	ISO 10993-10	Pass	ISO 10993-10
Guinea Pig Maximization	ISO 10993-10	Pass	ISO 10993-10

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

The document does not specify the exact sample sizes used for each test (e.g., for physical properties, protein content, or biocompatibility). It states that testing was performed according to specific ASTM and ISO standards, which would imply certain sample size requirements within those standards. However, the specific numbers are not reported.

The data provenance is not explicitly stated in terms of country of origin, nor is it explicitly labeled as retrospective or prospective. It is implied to be data collected as part of the device's development and testing for this premarket notification.

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

This information is not applicable to the device described. The device is a surgical glove, and its performance is evaluated against established physical, chemical, and biological standards (ASTM, ISO, CFR) rather than against expert-established ground truth in a diagnostic or interpretive sense. The "ground truth" here is the adherence to these published standards.

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are typically used in studies where human interpretation or assessment is involved (e.g., medical image reading). Since this submission concerns a physical medical device (surgical gloves) and its compliance with technical standards, such adjudication methods are not relevant or described. The tests are objective measurements against defined criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic or interpretive devices where human readers are involved. For surgical gloves, the evaluation focuses on meeting predefined physical and biochemical standards.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The device is a physical product, not an algorithm, so a standalone study in this context is irrelevant.

7. Type of Ground Truth Used

The "ground truth" used is defined by adherence to established industry and regulatory standards. Specifically:

ASTM D3577 (for dimensions, physical properties, freedom from holes, powder residual)
21 CFR 800.20 (for AQL in freedom from holes)
ASTM D6124 (for testing powder residual)
ASTM D5712 (for protein content)
FDA Medical Glove Guidance Manual (for protein content)
ISO 10993-1 (for biocompatibility)
ISO 10993-10 (for primary skin irritation and guinea pig maximization)

8. Sample Size for the Training Set

Not applicable. This device is a physical medical product, not an AI/ML algorithm that requires a training set.

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

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

Summary

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K120934

MAY 2 3 2012

Image /page/0/Picture/2 description: The image shows the logo for Cardinal Health. The logo consists of a stylized graphic above the company name. The graphic appears to be three curved lines converging at a point, possibly representing birds in flight or a similar abstract design.

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

PROTEXISTM LATEX BASIC, STERILE LATEX POWDER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABEL CLAIM OF 50µg/dm2 OR LESS (TAN) (A summary of safety and effectiveness information in accordance with the requirements of 21 CFR 807.92)

Cardinal Health Applicant: 1430 Waukegan Road McGaw Park, IL 60085 Establishment Registration 1423537 Number: Regulatory Affairs Contact: Tatyana Bogdan, RAC Telephone: 847-887-2325 847-887-2717 Fax: tatyana.bogdan-curvin@cardinalhealth.com E-mail:

Summary Prepared: May 9, 2012

Protexis Tid Latex Basic, Sterile Latex Powder-Free Surgical Glove with Trade Name: Protein Content Label Claim of 50ug/dm2 or less (Tan) Surgeon's Gloves Common Name:

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 Ultrafree Sterile Powder-Free Latex/ Surgical Gloves (510(k) K964474, product code KGO)

Reason for 510(k) Submission:

New device

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

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

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K120934

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Characteristic	New Device	Predicate device
MaterialComposition	ProtexisTM Latex Basic, SterileLatex Powder-Free Surgical Gloveswith Protein Content Label Claimof 50 $\mu$ g/dm2 or less (Tan)	Ultrafree Sterile Latex Powder-FreeSurgical Glove (K964474)
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 fromHoles	AQL meets 21CFR 800.20 &ASTM D3577 requirements	AQL meets 21CFR 800.20 & ASTMD3577 requirements
Powder Residual	Meets requirements of $\le$ 2.0mg/glove for Powder-Freedesignation per ASTM D3577	Meets requirements of $\le$ 2.0 mg/glovefor Powder-Free designation perASTM D3577
Protein Contents	Contains less than 50 $\mu$ g/dm2 oftotal water extractable protein perglove as tested per ASTM D5712	N/A
Powder Residual	ASTM D3577 testedusing ASTM standardD6124	Gloves meet powder level requirements for“Powder-Free” designation per ASTMD3577. Results generated values < 2mg ofresidual powder per glove.
Protein Content	ASTM D5712, FDAMedical GloveGuidance Manual	Gloves yielded the results of less than 50$\mu$ g/dm² of total water extractable protein perglove
Comparative Performance Information Summary
Characteristic	Requirement	New Device	Predicate Device
Biocompatibility:	ISO 10993-1	Meets requirements	Meets requirements
Primary Skin Irritation	ISO 10993-10	Pass	Pass
Guinea PigMaximization	ISO 10993-10	Pass	Pass
Dimensions	ASTM D3577	Meets requirements	Meets requirements
Physical Properties	ASTM D3577	Meets requirements	Meets requirements
Freedom from Holes	21CFR800.20,ASTM D3577	Meets requirements	Meets requirements
Powder Residual	ASTM D3577	Meets requirements	Meets requirements
Protein Content	ASTM D5712	Pass	Pass
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF
SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION
Clinical data is not required.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
Non-clinical data demonstrates that ProtexisTM Latex Basic, Sterile Latex Powder-Free Surgical

Cardinal Health, Inc.
Premarket Notification Submission – Traditional 510(k)

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20934

Gloves with Protein Content Label Claim (50 micrograms or less) meet the technological characteristics of ASTM D3577 standard, and are as safe, as effective, and performed as well as the legally marketed 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 & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized wing segments.

Public Health Service

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

Cardinal Health, Incorporated C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories, Inc. 333 Pfingsten Road Northbrook, Illinois 60062

MAY 2 3 2012

Re: K120934

Trade/Device Name: Protexis™ Latex Basic, Sterile Latex Powder-Free Surgical Gloves with Protein Content Label Claim of 50 µg/dm4 or less

(Tan)

Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: May 10, 2012 Received: May 11, 2012

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. 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 - 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); 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,

Anthemments

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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Indications for Use

510(k) Number (if known): K120934

Device Name:

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

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 (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth D. Clavin-Willis

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

510(k) Number: K120934

Cardinal Health, Inc. Oardinal Houkh, Submission -- Traditional 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).