Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating by CARDINAL HEALTH 200, INC.

The proposed device is a sterile latex powder-free surgical glove that is formulated using natural rubber latex and is brown in color. The glove is coated with hydrogel polymer coating. The glove is manufactured using molds that feature an independent thumb and mechanically locking cuffs to help prevent cuff roll down. They are offered powder-free and sterile. This glove is for single use only. This glove is suitable for use as a specialty surgical glove intended for orthopedic procedures or other procedures where a thicker barrier may be desired such as trauma and reconstructive surgery.

AI/ML Overview

The provided document describes the predicate device and the performance data that supports substantial equivalence for the "Cardinal Health™ Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating." This is a medical device approval summary, and as such, it focuses on non-clinical tests to demonstrate performance in line with existing standards for gloves, rather than a study for an AI-powered diagnostic device.

Therefore, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone study, type of ground truth, training set size, ground truth for training set) are not applicable to this type of device and submission.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria (Standard/Test/FDA Guidance)	Reported Device Performance (New Device)
Biocompatibility (Overall)	ISO 10993-1	Meets requirements
Primary Skin Irritation	ISO 10993-10	Pass (Under conditions of the study, gloves are non-irritating.)
Guinea Pig Maximization	ISO 10993-10	Pass (Under the conditions of the study, gloves do not display any potential for sensitization.)
Dimensions	ASTM D3577	Meets requirements
Physical Properties	ASTM D3577	Meets requirements for rubber surgical gloves
Freedom from Holes	21 CFR 800.20 & ASTM D3577	Meets requirements (Tested in accordance with ASTM D5151 with acceptable results)
Powder Residual	ASTM D3577	Meets requirements of ≤ 2.0 mg/glove for "Powder-Free" designation (Results generated values < 2mg of residual powder per glove.)
Protein Content	FDA Medical Glove Guidance Manual, ASTM D5712	Pass (Gloves yielded the results of less than 50 µg/dm² of total water extractable protein per glove.)
Puncture Resistance	AS/NZ 4179	Pass (Tested in accordance with AS/NZ with acceptable results)

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

Sample Size: Not explicitly stated. For medical gloves, testing is typically done on a representative sample from production lots according to the specified ASTM standards. The standards themselves define the sampling plans.
Data Provenance: The tests are non-clinical (laboratory/material tests). As such, there is no "country of origin of the data" in the sense of patient data. The tests were performed by the manufacturer (Cardinal Health 200, LLC) in a laboratory setting to demonstrate compliance with international and national standards. These are retrospective analyses of material properties.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. These are objective physical and chemical property tests, not expert-adjudicated diagnostic interpretations. The "ground truth" is defined by the technical specifications and methodologies of the referenced ASTM, ISO, and FDA standards.

4. Adjudication method for the test set

Not applicable. The tests involve objective measurements against defined criteria, not subjective interpretations requiring adjudication.

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 is not an AI-powered diagnostic device.

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

Not applicable. This is not an AI-powered diagnostic device.

7. The type of ground truth used

Ground Truth: The "ground truth" is defined by the Pass/Fail criteria and quantitative limits specified in the referenced international standards (ASTM D3577, ISO 10993-10, AS/NZ 4179) and FDA guidance for medical gloves (e.g., 21 CFR 800.20, FDA Medical Glove Guidance Manual, ASTM D5712). These standards establish the acceptable physical, chemical, and biological properties for safe and effective surgical gloves.

8. The sample size for the training set

Not applicable. This device does not involve a training set as it is not a machine learning or AI algorithm.

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

Not applicable. This device does not involve a training set.

Summary

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

March 24, 2016

Cardinal Health 200, LLC. Ms. Caroline Miceli Manager, Regulatory Affairs 1500 Waukegan Road Waukegan, Illinois 60085

Re: K151778

Trade/Device Name: Cardinal Health 111 Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: February 18, 2016 Received: February 22, 2016

Dear Ms. Caroline Miceli:

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.

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory 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) K151778

Device Name

Cardinal Health TM Sterile Latex Powder-Free Orthopedic Surgical Gloves With Hydrogel Coating

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)
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| | Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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