Cardinal Health™ Non-Reinforced Surgical Gown is intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). The Cardinal Health™ Non-Reinforced Surgical Gowns are single use, disposable medical devices; provided sterile and non-sterile.

Device Description

The Cardinal Health™ Non-Reinforced Surgical Gown is a Class II medical device under the FDA product code of FYA, General & Plastic Surgery Panel, and Regulation 21 CFR 878.4040. The device description of the Cardinal Health™ Non-Reinforced Surgical Gown is in accordance with the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued on August 1, 1993.

The chest front and sleeve critical zones of the Cardinal Health™ Non-Reinforced Surgical Gowns are constructed from a blue polyolefin SMS (spunbond, meltblown, spunbond) and have been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical gown. The Cardinal Health™ Non-Reinforced Surgical Gown is a single use, disposable medical device that will be provided in a variety of sterile and nonsterile packaging configurations.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a Cardinal Health™ Non-Reinforced Surgical Gown (K170762). This document focuses on demonstrating the substantial equivalence of the new device to a predicate device (Convertors® SMS Polyolefin Standard Gown (K020593)) through performance testing against established standards for surgical gowns. This is not a study of a device employing AI or machine learning.

Therefore, many of the requested fields are not applicable (N/A) to this type of medical device submission. However, I can extract information related to acceptance criteria and performance testing:

1. Table of Acceptance Criteria and Reported Device Performance

Test/Element of Comparison	Predicate Device (K020593) Test Results	Proposed Device (Cardinal Health™ Non-Reinforced Surgical Gown) Test Results (Mean)	Specification/Acceptance Criteria (for Proposed Device)
Physical Properties
Basis weight (oz/yd2) - ASTM D3776	N/A (older standard used)	1.32 oz/yd2	Target Mean= 1.30; Mean Min = 1.20; Ind Min = 1.07
Grab tensile, MD (lbs) - ASTM D5034	N/A (older standard used)	21.57 lbs	N/A (no specific specification provided for proposed mean)
Grab tensile, CD (lbs) - ASTM D5034	N/A (older standard used)	13.60 lbs	Target Mean = 15.00; Mean Min = 11.00; Ind Min = 9.50
Trap Tear, MD (lbs) - ASTM D5587-15	3.2-7.4 lbs	3.47 lbs	Target Mean = 4.00; Mean Min = 2.40; Ind Min = 2.00
Trap Tear, CD (lbs) - ASTM D5587-15	7.0-11.8 lbs	5.63 lbs	N/A (no specific specification provided for proposed mean)
Flammability (sec) - CPSC, Part 1610	Class I	Class I	Class I
Alcohol Repellency (rating) - NWSP	>6	9	Target Mean = 7; Mean Min = 6; Ind Min = 5
Hydrostatic Head (cm) - AATCC-127	65-92 cm	89.90 cm	Target Mean = 70; Mean Min = 60; Ind Min = 53
Water Impact (g) - AATCC-42	0.0-0.10 g	0.10 g	Target Mean = 0.10; Mean Max = 0.30; Ind Max = 1.0
Liquid Barrier Performance
AAMI Level 3 barrier protection	Met equivalent AAMI Level 3	Meets AAMI Level 3 barrier protection requirements	AAMI Level 3 barrier protection
Biocompatibility
Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity (ISO 10993-1)	Met requirements and acceptable	Non-cytotoxic, non-irritating, and non-sensitizing	Non-cytotoxic, non-irritating, and non-sensitizing

2. Sample size used for the test set and the data provenance
The document states that for Liquid Barrier Performance Classification Properties, "Testing was performed using 3 lots and 32 samples per lot in each critical zone area." The critical zones tested were the body and sleeve (same fabric), the sleeve seam, and front belt attachment.
For other physical properties (e.g., basis weight, grab tensile), test results are reported as "Test Results (3 Lots)," indicating multiple samples were taken from three different production lots. The data provenance is not explicitly stated, but it can be inferred that these are prospective tests conducted by the manufacturer (Cardinal Health) on their proposed device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. This device submission does not involve clinical data that would require expert-established ground truth. The "ground truth" for this device is based on standardized physical and barrier performance tests.

4. Adjudication method for the test set
N/A. This device submission does not involve clinical data or interpretations that require 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
N/A. This is a surgical gown, not an AI/ML-enabled diagnostic or interpretive device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is a surgical gown, not an AI/ML-enabled device.

7. The type of ground truth used
The "ground truth" for this device is based on objective, standardized laboratory test methods and specifications as defined by organizations like ASTM, AATCC, NWSP, CPSC, and ANSI/AAMI PB70:2012. For biological safety, it's based on the requirements of ISO 10993-1.

8. The sample size for the training set
N/A. This is a surgical gown, not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established
N/A. This is a surgical gown, not an AI/ML device that requires a training set with ground truth.

Summary

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Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a series of human profiles, with three interconnected figures facing to the right.

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

June 9, 2017

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

Re: K170762

Trade/Device Name: Cardinal Health™ Non-Reinforced Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: March 10, 2017 Received: March 13, 2017

Dear 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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device

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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 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,

Lori A. Wiggins -S6

Lori A. Wiggins, MPT, CLT Acting 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)

K170762

Device Name

Cardinal Health™ Non-Reinforced Surgical Gown

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)	Exempted under Health & Safety Code section 25200.3.1 Interim Tiered Permit under Health & Safety Code section 25200.5
-------------------------------------------------	----------------------------------------------------------------------------------------------------------------------------------------------------------

| | Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/1 description: The image shows the logo for Cardinal Health. The logo consists of a stylized red bird-like design above the company name. The name "CardinalHealth" is written in a bold, sans-serif font, with "Cardinal" in black and "Health" in a slightly darker shade of black.

K170762

1500 Waukegan Road Waukegan, IL 60085 www.cardinalhealth.com

510(k) SUMMARY Cardinal Health™ Non-Reinforced Surgical Gown

Manufacturer:	Cardinal Health 200, LLC1500 Waukegan RoadWaukegan, IL 60085
Regulatory Affairs Contact:	Caroline Miceli1500 Waukegan RoadWaukegan, IL 60085
Telephone Number:	(847) 887-6864
Fax Number:	(847) 785-2461
Date Summary Prepared:	March 10, 2017
Trade Name:	Cardinal HealthTM Non-Reinforced Surgical Gown
Regulation Number:	21 CFR §878.4040
Device Class:	Class II
Regulation Name:	Surgical Apparel
Common Name:	Surgical Gown
Product Code:	FYA
Classification Name:	Surgical Gown
Predicate Device:	Convertors® SMS Polyolefin Standard Gown (K020593)

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Description

Indications for Use/Intended Use

The Cardinal Health™ Non-Reinforced Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate material. In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. The Cardinal Health™ Non-Reinforced Surgical Gowns are single use, disposable medical devices, provided sterile and non-sterile.

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Device and Predicate Device Technical Characteristics

The proposed Cardinal Health™ Non-Reinforced Surgical Gown is substantially equivalent to the predicate Convertors® SMS Polyolefin Standard Gown (K020593) with regards to claims, design, technology, and intended use. Refer to the Side by Side Comparison Table below.

The final proposed finished device was tested in accordance with Guidance on Premarket Notification [510(k)] Submission for Surgical Gowns and Surgical Drapes, August 1993, Guidance for Industry and FDA Staff - Premarket Notification Requirements Concerning Gowns Intended for Use in Healthcare Settings issued by the FDA on December 9, 2015 and ANSI/AAMI PB70:2003, Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. The Cardinal Health™ Non-Reinforced Surgical Gowns consists of Polyolefin (Polypropylene) SMS nonwoven material including sleeve seams but excluding cuffs, hems, and bindings per AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Drapes Intended for Use in Health care Facilities. Testing was performed on the body and sleeve (equivalent material), sleeve seam, and belt attachment to generate test data shown in the table below. Additional performance testing was performed to further characterize the device.

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Side by Side Comparison Predicate Device: Convertors® SMS Polyolefin Standard Gown Proposed Device: Cardinal Health™ Non-Reinforced Surgical Gown

Element ofComparison	Predicate Device:Convertors® SMS PolyolefinStandard Gown (K020593)	Proposed Device:Cardinal HealthTM Non-ReinforcedSurgical Gown
IntendedUse/Indications for Use	Convertors® SMS PolyolefinGowns are intended to beworn by operating roompersonnel during surgicalprocedures to protect thesurgical patient and operatingroom personnel from thetransfer of microorganisms,body fluids and particulatematerial.	The Cardinal HealthTM Non-Reinforced Surgical Gowns areintended to be worn by operatingroom personnel during surgicalprocedures to protect the surgicalpatient and operating room personnelfrom the transfer of microorganisms,body fluids and particulate material. Inaddition, this surgical gown meets therequirements of AAMI Level 3 barrierprotection for a surgical gown perANSI/AAMI PB70:2012 Liquidbarrier performance and classificationof protective apparel and drapesintended for use in health carefacilities. The Cardinal HealthTM Non-Reinforced Surgical Gowns are singleuse, disposable medical devices,provided sterile and non-sterile.
Directions for Use	None	Follow your facility protocol.
Material Composition	Polyolefin (Polypropylene)SMS nonwoven	Polyolefin (Polypropylene) SMSnonwoven
Design Features	Neck Closure: Hook and LoopBelt TiesKnit CuffsTransfer Tab	Neck Closure: Hook and LoopBelt TiesKnit CuffsTransfer Tab
Sterility	Sterile and non-sterile	Sterile and non-sterile
Use	Single Use; Disposable	Single Use; Disposable
Color	Light Blue	Dark Blue

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Element of	Predicate Device:	Proposed Device:
Comparison	Convertors® SMS PolyolefinGown – Standard Gown(K020593)	Cardinal HealthTM Non-Reinforced SurgicalGown (Representative Catalog Number 9545)
	K020593 Test Results	Test Results (3 Lots)		Specification
		Mean (min/max)
		Sleeve	Body

Basis weight (oz/yd2)
ASTM D1910-75**	1.6 - 1.8 oz/yd2	N/A: ASTM D1910-75 replaced by ASTMD3776
ASTM D3776	N/A: Current Test Method	Mean = 1.32	Mean = 1.32	Target Mean=1.30
		Ind Min =1.28	Ind Min =1.28	Mean Min = 1.20
		Ind Max =1.36	Ind Max =1.36	Ind Min = 1.07

Grab tensile, MD*(lbs)
ASTM D882-83**	25-34 lbs.	N/A: ASTM D882-83 replaced by ASTMD5034
ASTM D5034	N/A: Current Test Method	Mean =21.57	Mean =21.57	N/A
		Ind Min =18.60	Ind Min =18.60
		Ind Max =23.60	Ind Max =23.60

Grab tensile, CD*(lbs)
ASTM D882-83**	13-20 lbs.	N/A: ASTM D882-83 replaced by ASTMD5034
ASTM D5034	N/A: Current Test Method	Mean =13.60	Mean =13.60	Target Mean =15.00
		Ind Min =11.20	Ind Min =11.20	Mean Min =11.00
		Ind Max =	Ind Max =	Ind Min = 9.50
		16.0	16.0

Trap Tear, MD* (lbs)
ASTM D5587-15Highest Peak	3.2-7.4 lbs.	Mean = 3.47	Mean = 3.47	Target Mean =4.00
		Ind Min =	Ind Min =	Mean Min = 2.40
		2.73Ind Max =4.00	2.73Ind Max =4.00	Ind Min = 2.00

Element ofComparison	Predicate Device:Convertors® SMS PolyolefinGown – Standard Gown(K020593)	Proposed Device:Cardinal Health™ Non-Reinforced SurgicalGown (Representative Catalog Number 9545)
	K020593 Test Results	Test Results (3 Lots)Mean (min/max)		Specification
		Sleeve	Body
Trap Tear, CD* (lbs)ASTM D5587-15Highest Peak	7.0-11.8 lbs.	Mean = 5.63Ind Min =4.67Ind Max =7.90	Mean = 5.63Ind Min =4.67Ind Max =7.90	N/A
Flammability (sec)CPSC, Part 1610	Class I	Class I	Class I	Class I
Alcohol Repellency(rating)NWSP 080.8.R0 (15)	>6	Mean = 9Ind Min = 8Ind Max = 9	Mean = 9Ind Min = 8Ind Max = 9	Target Mean = 7Mean Min = 6Ind Min = 5
Hydrostatic Head(cm)AATCC-127	65-92 cm	Mean =89.90Ind Min =73.95Ind Max =100.98	Mean =89.90Ind Min =73.95Ind Max =100.98	Target Mean = 70Mean Min = 60Ind Min = 53
Water Impact (g)AATCC-42	0.0-0.10 g	Mean = 0.10Ind Min =0.07Ind Max =0.13	Mean = 0.10Ind Min =0.07Ind Max =0.13	Target Mean =0.10Mean Max = 0.30Ind Max = 1.0

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Note - Individual Maximum (Ind. Max.): specification allows only one value at this level. Individual minimum (Ind. Min.): specification allows only one value at this level. The mean performance of the proposed device was compared to the mean specification values.

MD Grab tensile not specified, CD Grab tensile is limiting specification value; CD Trap Tear is not specified; MD Trap Tear is the limiting specification value as it is the weaker direction.

** Predicate test methods for basis weight and grab tensile strength were accepted test methods at the time; proposed device was tested on current standards.

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Element of Comparison	Predicate Device:Convertors® SMS Polyolefin Standard Gown (K020593)	Proposed Device:Cardinal Health TM Non-Reinforced Surgical Gown
Liquid Barrier Performance Classification Properties	PB70 Performance Standard was not available at the time of the predicate submission. However, Water Impact and Hydrostatic Head tests were performed and met the equivalent AAMI Level 3 per PB70.	Device was tested in accordance with AAMI PB70:2012 and meets AAMI Level 3 barrier protection requirements for a surgical gown. Testing was performed using 3 lots and 32 samples per lot in each critical zone area. The critical zone areas tested were the body and sleeve (same fabric), the sleeve seam, and front belt attachment.
Biocompatibility	All Materials used in the fabrication of this gown were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 Biological Evaluation of Medical Devices”. The biocompatibility test performed were cytotoxicity, sensitization, and irritation/intracutaneous reactivity. These materials have met the requirements of the guidance and were found to be acceptable for the intended use.	Under the conditions of each study, the Cardinal HealthTM Non-Reinforced Surgical gown is non-cytotoxic, non-irritating, and non-sensitizing per ISO 10993-1.
Sterilization Modality	Ethylene Oxide (EO)	Ethylene Oxide (EO)

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Conclusion Summary

The Cardinal Health™ Non-Reinforced Surgical gowns are substantially equivalent to the predicate device, in terms of general intended use, performance testing, barrier protection, material composition, and configuration/dimensions. Under the conditions of each study, the Cardinal Health™ Isolation gown is non-cytotoxic, nonirritating, and non-sensitizing per ISO-10993 and have met the requirements of ANSI/AAMIPB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities for an AAMI Level 3 surgical gown. Therefore, the subject device is determined as safe and as effective for its intended use as the predicate device.

Conclusion Statement

The Cardinal Health™ Non-Reinforced Surgical gowns are as safe, as effective and performs as well as the legally marketed device identified in this submission.

Regulation Number and Section

§ 878.4040 Surgical apparel.

(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.