Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a surgical gown and its physical barrier properties, with no mention of AI or ML technology.

Therapeutic

No
The device is a surgical gown intended to protect against transfer of microorganisms, body fluids, and particulate material, not to treat or cure a disease or condition.

Diagnostic

No
Explanation: The device is a surgical gown intended to protect patients and operating room personnel from the transfer of microorganisms and fluids. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device is a surgical gown, which is a physical product made of multiple layers of nonwoven material and film. The description focuses on its material construction and physical barrier properties, not software functionality.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the gown is for "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." This describes a barrier device used for protection, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
Device Description: The description focuses on the physical construction and barrier properties of the gown.
Performance Studies: The performance studies listed are related to the physical properties and barrier performance of the gown (e.g., strength, water resistance, penetration resistance), not diagnostic accuracy or analytical performance related to biological samples.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.

Therefore, the Cardinal Health SmartGown™ surgical gown is a medical device, but it falls under the category of protective apparel, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Cardinal Health SmartGown™ surgical gown is 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. The Cardinal Health SmartGown™ surgical gown is a single use, disposable medical device provided sterile and non-sterile.

This submission covers 12 models of Cardinal Health SmartGown™ surgical gown, see Table 1, Each model is a multilaver construction of a nonwoven outer layer, breathable film core and a nonwoyen inner laver, and has been tested according to AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities.

Product codes (comma separated list FDA assigned to the subject device)

FYA

Device Description

The Cardinal Health SmartGown™ surgical gowns are constructed of a multi-layer construction of a nonwoven outer layer, breathable film core and a nonwoven inner layer and have been tested according to AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health care Facilities. The Cardinal Health SmartGown™ surgical gown is a single use, disposable medical device that will be provided in a variety of sterile and non-sterile packaging configurations. This submission covers 12 models of Cardinal Health SmartGown surgical gowns, see Table 1 below.

The Cardinal Health SmartGown™ surgical gown is a single use, disposable medical device provided in a variety of sterile and non-sterile packaging configurations. Bulk non-sterile Cardinal Health SmartGown™ surgical gowns provided to convenience kit packers.

Non-sterile Cardinal Health SmartGown™ surgical gowns will include EO sterilization parameters on labeling as follows:

EO Concentration: 690 mg/L -
Temperature: 130 +/- 10ºF ﻴ
Exposure Time: 150 minutes ﻴ
Humidity: 50 +/- 5% ﺳ
Aeration Time: 18 hours 13

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

operating room personnel during surgical procedures

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Testing was performed according to the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued on August 1, 1993 and AAMI PB70: June 21, 2012, Liquid Barrier Performance Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities. All results of testing met ASTM F1671/F1671M-13, and meets AAMI PB70:2012 Level 4 requirements.

Final finished goods, that were twice EO sterilized (Cardinal Health SmartGown1™ surgical gown), were tested. The products were tested in the critical zones of the body and sleeve to generate test data shown in Table 4 above, including back panels where noted. Test results establish that the product meets predetermined acceptance criteria of specifications for intended use, to demonstrate device is safe and effective, as noted in Table 4 above.

Mass Per Unit Area (Basis Weight) of Woven Fabric .

ASTM D3776-09 Test Methods for Mass Per Unit Area (Weight) of Woven Fabric results were reported on the Body, Sleeve and Back Panel materials. The sample size used was n=32 and results were reported in mean, min and max.

Breaking Strength and Elongation of Textile Fabrics (Grab tensile) .

ASTM D5034-09 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test) results were reported on the Body, Sleeve and Back Panel materials. The sample size used was n=32 and results were reported in mean, min and max.

Bursting Strength of Textile Fabrics (Mullen burst) .

ASTM D774/D774M-97 (2007) Standard Test Method for Bursting Strength of Textile Fabrics (Mullen Burst) results were reported on the Body and Sleeve materials. The sample size used was n=32 and results were reported in mean, min and max.

Water Vapor Transmission of Materials, Upright cup ●

ASTM E96/E96M-13 Standard Test method for Water Vapor Transmission of Materials, Upright cup (WVTR) results were reported on the Body and Sleeve materials. The sample size used was n=32 and results were reported in mean, min and max.

Standard for the Flammability of Clothing Textiles ●

16 CFR Part 1610, Standard for the Flammability of Clothing Textiles. Flammability results were reported on the Body, Sleeve and Back Panel materials. The sample size used was n=32 and results were reported as the Flammability Classification Level.

Tearing Strength of Nonwoven Fabrics by the Trapezoid Procedure (Trap tear)

ASTM D5733-99 Standard Test Method for Tearing Strength of Nonwoven Fabrics by the Trapezoid Procedure results were reported on the Back Panel material. The sample size used was n=32 and results were reported in mean, min and max.

. Water Resistance: Impact Penetration Test

AATCC 42-2013 Water Resistance: Impact Penetration Test results were reported on the Back Panel material. The sample size used was n=32 and results were reported in mean. min and max.

Water Resistance: Hydrostatic Pressure Test .

AATCC 127:2013 Water Resistance: Hydrostatic Pressure Test results were reported on the Back Panel material. The sample size used was n=32 and results were reported in mean, min and max.

Resistance of Materials Used in Protective Clothing to Penetration by Synthetic . Blood - Gown
ASTM F1670-08, Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood. Results are reported as pass/fail. Procedure B was used, with a mesh screen to support the sample during testing. The sample size used was n=32 and results were reported as pass/fail.

Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System - Gown

ASTM F1671/F1671M-13, Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System. This method was used to characterize the AAMI PB70;2012 Liquid Barrier Performance Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities performance level, as compliant to level 4. Procedure B was used, with a mesh screen to support the sample during testing. The sample size used was n=32 and results were reported as pass/fail.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K012984 -Cardinal Health SmartGown™

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

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

May 21, 2015

Cardinal Health 200, LLC. Ms. Lavenia Ford Manager, Regulatory Affairs 1500 Waukegan Road Waukegan, IL 60685

Re: K150151 Trade/Device Name: SmartGown™ Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FYA. Dated: April 23, 2015 Received: April 24, 2015

Dear Ms. Ford,

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

1

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 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 I. Keith, M.S. 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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Image /page/2/Picture/0 description: The image shows the Cardinal Health logo. The logo consists of a stylized graphic element above the text "CardinalHealth". The graphic element appears to be a series of curved lines, possibly representing a bird in flight or a stylized representation of health and wellness. The text "CardinalHealth" is written in a bold, sans-serif font.

1500 Waukegan Road

Waukegan, IL 60085

www.cardinalhealth.com

510(k) SUMMARY SmartGown™ surgical gown

Manufacturer:

Cardinal Health 200, LLC 1500 Waukegan Road Waukegan, IL 60085

1500 Waukegan Road Waukegan, IL 60085

Regulatory Affairs Contact:

Telephone Number:

(847) 887-3323

Lavenia Ford

(847) 785-2461

April 21, 2015 Date summary Prepared:

Trade Name:

Fax Number:

SmartGown™ surgical gown

Regulation Number/Device Class: Class II per 21 CFR § 878.4040

FYA

Surgical Apparel Regulation Name:

Surgical Gown Common Name:

Product Code:

Predicate Device:

K012984 -Cardinal Health SmartGown™

3

Description

The Cardinal Health SmartGown™ surgical gowns are identified by Regulation 21 CFR 878.4040 with product code FYA.

The Cardinal Health SmartGown™ surgical gowns are constructed of a multi-layer construction of a nonwoven outer layer, breathable film core and a nonwoven inner layer and have been tested according to AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health care Facilities. The Cardinal Health SmartGown™ surgical gown is a single use, disposable medical device that will be provided in a variety of sterile and non-sterile packaging configurations. This submission covers 12 models of Cardinal Health SmartGown surgical gowns, see Table 1 below.

Indications for Use

Cardinal Health SmartGown™ surgical gown is 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. The Cardinal Health SmartGown™ surgical gown is a single use, disposable medical device provided sterile and non-sterile.

This submission covers 12 models of Cardinal Health SmartGown™ surgical gown, see Table 1 below. Each model is a multi-layer construction of a nonwoven outer layer, breathable film core and a nonwoven inner layer, and has been tested according to AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities.

		Catalog #
Sterile	Non-sterile
Single	Bulk	Hospital	Bulk Small Qty	Model Description	Model Size
89013	N/A	N/A	N/A	SmartGownTM surgical gown, Set-in sleeve	X-Small
89005	89005N	N/A	N/A	SmartGownTM surgical gown, Set-in sleeve	Small/Medium
89015	89015N	N/A	890015N	SmartGownTM surgical gown, Set-in sleeve	Large
89045	89045N	N/A	890045N	SmartGownTM surgical gown, Set-in sleeve	X-Large
89075	89075N	K89075N	N/A	SmartGownTM surgical gown, Set-in sleeve	XX-Large
39015	39015N	K39015N	N/A	SmartGownTM surgical gown, Raglan sleeve	Large
39045	39045N	N/A	N/A	SmartGownTM surgical gown, Raglan sleeve	X-Large
39049	39049N	K39049N	N/A	SmartGownTM surgical gown, Raglan sleeve	X-Large, X-Long
39075	39075N	N/A	N/A	SmartGownTM surgical gown, Raglan sleeve	XX-Large
39079	39079N	N/A	N/A	SmartGownTM surgical gown, Raglan sleeve	XX-Large, X-Long
39099	39099N	N/A	N/A	SmartGownTM surgical gown, Raglan sleeve	XXX-Large, X-
Long
32474	32474N	K32474N	324740N	SmartGownTM surgical gown (specialty),
Raglan sleeve	X-Large, X-Long,
A-Line

Table 1: Product Description and Catalog Number

The Cardinal Health SmartGown™ surgical gown is a single use, disposable medical device provided in a variety of sterile and non-sterile packaging configurations. Bulk non-sterile Cardinal Health SmartGown™ surgical gowns provided to convenience kit packers.

4

Non-sterile Cardinal Health SmartGown™ surgical gowns will include EO sterilization parameters on labeling as follows:

EO Concentration: 690 mg/L -
Temperature: 130 +/- 10ºF ﻴ
Exposure Time: 150 minutes ﻴ
Humidity: 50 +/- 5% ﺳ
Aeration Time: 18 hours 13

Device and Predicate Device Technical Characteristics

The proposed Cardinal Health SmartGown™ surgical gowns are primarily construction of nonwoven and nonwoven laminates (see Table 3).

Table 3: Proposed Cardinal Health SmartGown™ surgical gown description

| Design | Body and front tie
attachment AAMI PB70
Critical Zone | Sleeve and sleeve
seam AAMI PB70
Critical Zone | Back Panel AAMI
PB70 Non-Critical
Zone | Codes |
|-------------------------|---------------------------------------------------------------|-------------------------------------------------------------|----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Set-in sleeve | SMS / Film / SMS
Meets:
ASTM F1671
AAMI PB70 Level 4 | SB / Film / SB
Meets:
ASTM F1671
AAMI PB70 Level 4 | SMS / Film / SMS
Meets:
ASTM F1671
AAMI PB70 Level 4 | 89013
89005
89015
89045
89075
89005N
89015N
89045N
89075N
890015N
890045N
K89075N |
| Raglan sleeve | SMS/ Film / SMS
Meets:
ASTM F1671
AAMI PB70 Level 4 | SB / Film / SB
Meets:
ASTM F1671
AAMI PB70 Level 4 | SMS / Film / SMS
Meets:
ASTM F1671
AAMI PB70 Level 4 | 39015
39045
39049
39075
39079
39099
39015N
39045N
39049N
39075N
39079N
39099N
K39015N
K39049N |
| Raglan
sleeve, Aline | SMS / Film / SMS
Meets:
ASTM F1671
AAMI PB70 Level 4 | SB / Film / SB
Meets:
ASTM F1671
AAMI PB70 Level 4 | SMS
Meets:
AATCC 42 \u2264 1.0g
AATCC 127 \u2265
50cm
AAMI PB70 Level 3 | 32474
32474N
324740N
K32474N |

5

The Cardinal Health SmartGown™ surgical gowns consist of zones; body, sleeve and back panel. The body front and lower sleeve are critical per AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health care Facilities, refer to Table 3 below.

The Cardinal Health SmartGown™ surgical gowns are substantially equivalent to the predicate SmartGown surgical gown with regards to claims, safety and effectiveness, design, technology, and intended use. See Table 4 below.

The proposed Cardinal Health SmartGown™ surgical gown body and sleeve materials are a laminated structure consisting of an outer layer of polyolefin nonwoven, laminated to a monolithic breathable barrier film, which is laminated to an inner layer of polyolefin nonwoven. The body material is constructed of an outer layer of SMS polyolefin nonwoven, laminated to a monolithic breathable barrier film, which is laminated to an inner layer of SMS polyolefin nonwoven. The gown sleeves are constructed of an outer layer of SB polyolefin nonwoven, laminated to a monolithic barrier film, which is laminated to an inner layer of SB polyolefin

: nonwoven.

The proposed Cardinal Health SmartGown™ surgical gown (specialty) non-critical zone body back panels are constructed of polyolefin SMS nonwoven fabric. The surgical gown back panels are not a critical zone per AAMI PB70:2012.

Testing was performed according to the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued on August 1, 1993 and AAMI PB70: June 21, 2012, Liquid Barrier Performance Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities. All results of testing met ASTM F1671/F1671M-13, and meets AAMI PB70:2012 Level 4 requirements.

Table 4: Side by Side Comparison of Predicate device and Proposed Cardinal Health SmartGown™ surgical gown

| Element of Comparison | Predicate Cardinal Health
SmartGown™ surgical gown | Proposed Cardinal Health
SmartGown™ surgical gown |
|-----------------------|-------------------------------------------------------|------------------------------------------------------|
| | SmartGown™ surgical gown | SmartGown™ surgical gown |

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| Intended Use | | The predicate Cardinal Health
SmartGown™ surgical gown is
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.

The predicate Cardinal Health
SmartGown™ surgical gown is
intended for use in infection control
practices to reduce the potential
exposure of the wearer to blood and
body fluids.

The predicate Cardinal Health
SmartGown™ surgical gown is a single
use, disposable medical device,
provided sterile and non-sterile. | | The proposed Cardinal Health
SmartGown™ surgical gown is
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.

The proposed Cardinal Health
SmartGown™ surgical gown is
intended for use in infection control
practices to reduce the potential
exposure of the wearer to blood and
body fluids.

The proposed Cardinal Health
SmartGown™ surgical gown is a single
use, disposable medical device,
provided sterile and non-sterile. | |
|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Material Composition | | Predicate Cardinal Health
SmartGown™ surgical gown critical
zones are a multi-layer construction of
nonwoven outer (polyolefin spunmelt),
monolithic film core (copolyester),
nonwoven inner (carded polyester). | | Proposed Cardinal Health
SmartGown™ surgical gown body
critical zone is a multi-layer
construction of nonwoven outer
(polyolefin SMS), monolithic film core
(copolyester), nonwoven inner
(polyolefin SMS).

Proposed Cardinal Health
SmartGown™ surgical gown sleeves
critical zone are multi-layer
construction of nonwoven outer (SB),
monolithic film core, nonwoven inner
(SB). | |
| Design Feature | | Predicate Cardinal Health
SmartGown™ surgical gown is
provided with neck binding with hook
and loop tabs, belt ties, removable
transfer tab accessory, and cuffs | | Proposed Cardinal Health
SmartGown™ surgical gown is
provided with neck binding with hook
and loop tabs, belt ties, removable
transfer tab accessory, and cuffs.

,

ः

स

7

:

8

		requirements.
Sterilization Modality	Ethylene Oxide	Ethylene Oxide
Biocompatibility	Pass ISO 10993-1	Pass ISO 10993-1

Table 4 highlights the equivalencies and comparison between proposed Cardinal Health SmartGown™ surgical gown and predicate Cardinal Health SmartGown™ surgical gown.

Final finished goods, that were twice EO sterilized (Cardinal Health SmartGown1™ surgical gown), were tested. The products were tested in the critical zones of the body and sleeve to generate test data shown in Table 4 above, including back panels where noted. Test results establish that the product meets predetermined acceptance criteria of specifications for intended use, to demonstrate device is safe and effective, as noted in Table 4 above.

Mass Per Unit Area (Basis Weight) of Woven Fabric .

ASTM D3776-09 Test Methods for Mass Per Unit Area (Weight) of Woven Fabric results were reported on the Body, Sleeve and Back Panel materials. This method was used to characterize the basis weight of each fabric. The basis weight test indicates how much a square meter of the fabric weighs. Each test specimen is cut to a specific size and the mass of the specimen is measured on a laboratory scale. The basis weight is calculated from that information. Results are reported in grams per square meter. The sample size used was n=32 and results were reported in mean, min and max.

Breaking Strength and Elongation of Textile Fabrics (Grab tensile) .

ASTM D5034-09 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test) results were reported on the Body, Sleeve and Back Panel materials. This method was used to characterize the tensile strength of each fabric. The grab tensile test indicates the force a fabric can withstand before tearing when pulled in a given direction. The test was performed in both roll orientations; cross direction (CD) and machine direction (MD). The test specimen is placed in the clamps of a tensile testing machine. The test specimen is subjected to an increasing force as the jaws move apart at a specified constant rate. Results are reported as peak force values. Peak values reflect the maximum force the sample endured before the initiation of failure. Results are reported in pounds of force. The sample size used was n=32 and results were reported in mean, min and max.

Bursting Strength of Textile Fabrics (Mullen burst) .

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ASTM D774/D774M-97 (2007) Standard Test Method for Bursting Strength of Textile Fabrics (Mullen Burst) results were reported on the Body and Sleeve materials. This method was used to characterize the burst strength of each fabric. The bursting strength test indicates how the fabric will resist puncture by a blunt object. Each fabric specimen is clamped over a flexible diaphragm. The diaphragm is expanded by pressure to the point of specimen rupture. The difference between the total pressure required to rupture the specimen and the pressure on the diaphragm at time of specimen burst with clamp released is reported as the Mullen burst strength. Results are reported in pounds per square inch. The sample size used was n=32 and results were reported in mean, min and max.

Water Vapor Transmission of Materials, Upright cup ●

ASTM E96/E96M-13 Standard Test method for Water Vapor Transmission of Materials, Upright cup (WVTR) results were reported on the Body and Sleeve materials. This method was used to characterize the water vapor transmission rate of each fabric over a range of temperatures at 50%RH (23°C, 27°C, 32°C). The water vapor transmission rate test specimen is affixed over a sample cup of water. The prepped sample cup is weighed at time 0. The prepped sample cup is then is heated to the target temperature, in chamber with constant %RH. The prepped sample cup is then measured at predetermined time points to measure the mass loss (water vapor transmission thru the sample). The water vapor transmission rate results are reported as mass of water per unit of area per period of time (g/m2/24 hours). The sample size used was n=32 and results were reported in mean, min and max.

Standard for the Flammability of Clothing Textiles ●

16 CFR Part 1610, Standard for the Flammability of Clothing Textiles, provides methods of testing the flammability of clothing and textiles intended to be used for clothing, and establishes three classes of flammability. The standard sets forth the requirements which textiles shall meet to be so classified. Class 1 is the best performing class. Textiles meeting these requirements are generally accepted by the trade as having no unusual burning characteristics. The flammability test indicates the inherent flammability classification of the surgical gown. Flammability results were reported on the Body, Sleeve and Back Panel materials. The sample size used was n=32 and results were reported as the Flammability Classification Level.

Tearing Strength of Nonwoven Fabrics by the Trapezoid Procedure (Trap tear) �

ASTM D5733-99 Standard Test Method for Tearing Strength of Nonwoven Fabrics by the Trapezoid Procedure results were reported on the Back Panel material. This method

10

was used to characterize the tear strength of the material. The trapezoidal tear test indicates how the fabric will resist tearing around an existing hole or tear. The test was performed in both roll orientations; cross direction (CD) and machine direction (MD). A tear of specified size and orientation is initiated on the test specimen. The test specimen is placed in the clamps of a tensile testing machine. The test specimen is subjected to an increasing force as the jaws move apart at a specified constant rate. Results are reported as average trapezoidal tear strength, in pounds of force. The sample size used was n=32 and results were reported in mean, min and max.

. Water Resistance: Impact Penetration Test

AATCC 42-2013 Water Resistance: Impact Penetration Test results were reported on the Back Panel material. This method was used to characterize the water resistance to impact penetration of the material. The impact penetration test measures the fabric's resistance to penetration by liquids, which is a key barrier property. The test specimen and a fluid blotter paper are cut to a predetermined size. The blotter is then weighed prior to testing. The test specimen and blotter are then clamped onto the test fixture (test specimen on top of blotter). A predetermined amount of water is allowed to spray on the sample from a fixed distance and spray head. The blotter is then weighed to determine the amount of water penetration thru the sample. The amount of liquid penetration is the final blotter weight less the initial blotter weight. The results are reported in grams. The sample size used was n=32 and results were reported in mean. min and max.

Water Resistance: Hydrostatic Pressure Test .

AATCC 127:2013 Water Resistance: Hydrostatic Pressure Test results were reported on the Back Panel material. This method was used to characterize the resistance of a fabric to the penetration of water under hydrostatic pressure, which is a key barrier property. The test specimen is clamped the test chamber, which is filled with water to contact the sample. The water pressure is gradually increased, exerting greater pressure onto the fabric. The unexposed side of the fabric is observed for water droplets, signaling failure of the barrier feature of the test fabric. Eventually, leakage occurs, marking the end of the test. The greater water pressure, the more repellent the fabric. Results are reported in centimeters of water. The sample size used was n=32 and results were reported in mean, min and max.

Resistance of Materials Used in Protective Clothing to Penetration by Synthetic . Blood - Gown

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ASTM F1670-08, Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood, evaluates the effectiveness of materials used in protective clothing for protecting the wearer against contact with body fluids that potentially contain blood-borne pathogens. This test method is intended to identify protective clothing material candidates for further testing according to a more rigorous procedure involving a surrogate for blood-borne pathogens. The test specimen is clamped onto the open face of pressure chamber of defined size, with a retaining ring around the outer circumference of the specimen. The pressure chamber is filled with synthetic blood. The specimen is exposed to the synthetic blood for a defined dwell period of time at ambient pressure. Then, chamber is pressurized, at a specified constant rate, to a maximum of 2 psi, for a defined period of time. The chamber is then allowed to revert to ambient pressure, and the specimen is exposed to the synthetic blood for a defined dwell period of time, to the conclusion of the test. A mesh screen may be used to support the specimen. Throughout the cycle, the reverse side of the fabric is observed for synthetic blood droplets, signaling failure of the barrier feature of the test fabric. If no droplets are observed thru the entire cycle, the sample passes. Results are reported as pass/fail. Procedure B was used, with a mesh screen to support the sample during testing. The sample size used was n=32 and results were reported as pass/fail.

Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System - Gown

ASTM F1671/F1671M-13, Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System, evaluates the effectiveness of materials used in protective clothing for protecting the wearer against contact with blood-borne pathogens using a surrogate microbe suspended in a body fluid simulant under conditions of continuous contact. The test specimen is clamped onto the open face of a pressure chamber, with a retaining ring around the outer circumference of the specimen. The pressure chamber is filled with fluid test media containing a surrogate microbe. The specimen is exposed to the fluid media for a defined dwell period of time under ambient pressure. Then, chamber is pressurized, at a specified constant rate, to a maximum of 2 psi, for a defined period of time. The chamber is then allowed to revert to ambient pressure, and the specimen is exposed to the fluid media for a defined dwell period of time, to the conclusion of the test. A mesh screen may be used to support the specimen. Throughout the cycle, the reverse side of the fabric is observed for fluid media droplets, signaling failure of the barrier feature of the test fabric. If no droplets are observed thru the entire cycle, the sample will then be plated for bacteriological assay. A specimen showing liguid penetration constitutes a failure. A specimen assay identifying evidence of viable microbe that penetrates the material, even when liquid penetration is not visible, constitutes a failure. Results are reported as passffail.

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This method was used to characterize the AAMI PB70;2012 Liquid Barrier Performance Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities performance level, as compliant to level 4. Procedure B was used, with a mesh screen to support the sample during testing. The sample size used was n=32 and results were reported as pass/fail.

Nonwoven and nonwoven laminate materials are characterized by basis weight as opposed to thickness as basis weight is a more precise method to characterize nonwoven and nonwoven laminate performance. This is in compliance with physical specification requirements outlined in Section 3.a.1 of Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued on August 1, 1993, where it states that weight per square yard or thickness, may be used as applicable.

Based on ASTM F2407-06R13. Table 2. Note B. there are no generally accepted test methods for snag or puncture resistance available at this time for nonwoven laminates.

The proposed product does not affect the substantial equivalence of the device, as explained below:

· Intended use
The proposed Cardinal Health SmartGown™ surgical gown intended use is substantially equivalent to the predicate Cardinal Health SmartGown™ surgical gown. Intended use of proposed is the same as the predicate. The Cardinal Health SmartGown™ surgical gown is a sterile, single use, disposable medical device. Cardinal Health SmartGown™ surgical gown is 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.

Conclusion Statement

Based on the results of the biocompatibility and physical performance testing the Cardinal Health SmartGown™ surgical gowns are as safe and as effective for their intended use as the predicate device. The Cardinal Health SmartGown™ surgical gowns are substantially equivalent to the predicate device, in terms of general intended use performance testing, material composition, configuration/dimensions and safety and effectiveness.

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Indications for Use

510(k) Number (if known) K150151

Device Name SmartGownTM surgical gown

Indications for Use (Describe)

Cardinal Health SmartGown™ surgical gown is 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. The Cardinal Health SmartGown™ surgical gown is a single use, disposable medical device provided sterile and non-sterile.

This submission covers 12 models of Cardinal Health SmartGown™ surgical gown, see Table 1, Each model is a multilaver construction of a nonwoven outer layer, breathable film core and a nonwoyen inner laver, and has been tested according to AAMI PB70:2012 Liquid Barrier and Performance Classification of Protective Apparel and Surgical Drapes Intended for Use in Health Care Facilities.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Table 1: Product Description and Catalog Number

Catalog #
Sterile	Non-sterile
Single	Bulk	Hospital	Bulk Small Qty	Model Description	Model Size
89013	N/A	N/A	N/A	SmartGownTM surgical gown, Set-in sleeve	X-Small
89005	89005N	N/A	N/A	SmartGownTM surgical gown, Set-in sleeve	Small/Medium
89015	89015N	N/A	890015N	SmartGownTM surgical gown, Set-in sleeve	Large
89045	89045N	N/A	890045N	SmartGownTM surgical gown, Set-in sleeve	X-Large
89075	89075N	K89075N	N/A	SmartGownTM surgical gown, Set-in sleeve	XX-Large
39015	39015N	K39015N	N/A	SmartGownTM surgical gown, Raglan sleeve	Large
39045	39045N	N/A	N/A	SmartGownTM surgical gown, Raglan sleeve	X-Large
39049	39049N	K39049N	N/A	SmartGownTM surgical gown, Raglan sleeve	X-Large, X-Long
39075	39075N	N/A	N/A	SmartGownTM surgical gown, Raglan sleeve	XX-Large
39079	39079N	N/A	N/A	SmartGownTM surgical gown, Raglan sleeve	XX-Large, X-Long
39099	39099N	N/A	N/A	SmartGownTM surgical gown, Raglan sleeve	XXX-Large, X-Long
32474	32474N	K32474N	324740N	SmartGownTM surgical gown (specialty), Raglan sleeve	X-Large, X-Long, A-Line

The Cardinal Health SmartGown™ surgical gown is a single use, disposable medical device provided in a variety of sterile and non-sterile packaging configurations. Bulk non-sterile Cardinal Health SmartGown™ surgical gowns provided to convenience kit packers.

Non-sterile Cardinal Health SmartGown™ surgical gowns will include EO sterilization parameters on labeling as follows:

EO Concentration: 690 mg/L -
Temperature: 130 +/- 10ºF -
Exposure Time: 150 minutes
Humidity: 50 +/- 5% -
Aeration Time: 18 hours