Cardinal Health Non-Reinforced Surgical Gown

K170762 · Cardinal Health200, LLC · FYA · Jun 9, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K170762
• Device Name: Cardinal Health Non-Reinforced Surgical Gown
• Applicant: Cardinal Health200, LLC
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Jun 9, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

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 Story

Single-use, disposable surgical gown; constructed from blue polyolefin SMS (spunbond, meltblown, spunbond) nonwoven material. Worn by operating room personnel during surgical procedures. Provides AAMI Level 3 barrier protection against microorganisms, body fluids, and particulate material. Protects both patient and wearer. Features include neck closure, belt ties, knit cuffs, and transfer tab. Provided in sterile and non-sterile configurations. Performance verified via AAMI PB70:2012 testing for liquid barrier properties.

Clinical Evidence

Bench testing only. Performance evaluated against AAMI PB70:2012, ASTM D3776 (basis weight), ASTM D5034 (grab tensile), ASTM D5587-15 (trap tear), CPSC Part 1610 (flammability), NWSP 080.8.R0 (alcohol repellency), AATCC-127 (hydrostatic head), and AATCC-42 (water impact). Biocompatibility testing performed per ISO 10993-1 (cytotoxicity, sensitization, irritation).

Technological Characteristics

Material: Polyolefin (polypropylene) SMS nonwoven. Barrier: AAMI Level 3 per ANSI/AAMI PB70:2012. Sterilization: Ethylene Oxide (EO). Design: Non-reinforced, single-use, disposable. Testing standards: ASTM D3776, ASTM D5034, ASTM D5587-15, CPSC 1610, NWSP 080.8.R0, AATCC-127, AATCC-42.

Indications for Use

Indicated for operating room personnel during surgical procedures to protect patients and personnel from transfer of microorganisms, body fluids, and particulate material. Suitable for use in healthcare facilities requiring AAMI Level 3 barrier protection.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Convertors® SMS Polyolefin Standard Gown (K020593)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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

1. Cardinal Health™ Non-Reinforced Surgical Gown

#### Indications for Use (Describe)

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.

| Type of Use (Select one or both, as applicable) | <span>Exempted under Health &amp; Safety Code section 25200.3.1</span> <span>Interim Tiered Permit under Health &amp; Safety Code section 25200.5</span> |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|

| | 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, LLC<br>1500 Waukegan Road<br>Waukegan, IL 60085 |
|-----------------------------|----------------------------------------------------------------------|
| Regulatory Affairs Contact: | Caroline Miceli<br>1500 Waukegan Road<br>Waukegan, IL 60085 |
| Telephone Number: | [phone] |
| Fax Number: | [phone] |
| 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

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.

## 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 of<br>Comparison | Predicate Device:<br>Convertors® SMS Polyolefin<br>Standard Gown (K020593) | Proposed Device:<br>Cardinal HealthTM Non-Reinforced<br>Surgical Gown |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use/Indications for Use | Convertors® SMS Polyolefin<br>Gowns are intended to be<br>worn by operating room<br>personnel during surgical<br>procedures to protect the<br>surgical patient and operating<br>room personnel from the<br>transfer of microorganisms,<br>body fluids and particulate<br>material. | The Cardinal HealthTM Non-<br>Reinforced Surgical Gowns are<br>intended to be worn by operating<br>room personnel during surgical<br>procedures to protect the surgical<br>patient and operating room personnel<br>from the transfer of microorganisms,<br>body fluids and particulate material. In<br>addition, this surgical gown meets the<br>requirements of AAMI Level 3 barrier<br>protection for a surgical gown per<br>ANSI/AAMI PB70:2012 Liquid<br>barrier performance and classification<br>of protective apparel and drapes<br>intended for use in health care<br>facilities. The Cardinal HealthTM Non-<br>Reinforced Surgical Gowns are single<br>use, disposable medical devices,<br>provided sterile and non-sterile. |
| Directions for Use | None | Follow your facility protocol. |
| Material Composition | Polyolefin (Polypropylene)<br>SMS nonwoven | Polyolefin (Polypropylene) SMS<br>nonwoven |
| Design Features | Neck Closure: Hook and Loop<br>Belt Ties<br>Knit Cuffs<br>Transfer Tab | Neck Closure: Hook and Loop<br>Belt Ties<br>Knit Cuffs<br>Transfer 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 Polyolefin<br>Gown – Standard Gown<br>(K020593) | Cardinal HealthTM Non-Reinforced Surgical<br>Gown (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 ASTM<br>D3776 | | |
| ASTM D3776 | N/A: Current Test Method | Mean = 1.32 | Mean = 1.32 | Target Mean=<br>1.30 |
| | | Ind Min =<br>1.28 | Ind Min =<br>1.28 | Mean Min = 1.20 |
| | | Ind Max =<br>1.36 | Ind Max =<br>1.36 | Ind Min = 1.07 |
| | | | | |
| Grab tensile, MD*<br>(lbs) | | | | |
| ASTM D882-83** | 25-34 lbs. | N/A: ASTM D882-83 replaced by ASTM<br>D5034 | | |
| ASTM D5034 | N/A: Current Test Method | Mean =<br>21.57 | Mean =<br>21.57 | N/A |
| | | Ind Min =<br>18.60 | Ind Min =<br>18.60 | |
| | | Ind Max =<br>23.60 | Ind Max =<br>23.60 | |
| | | | | |
| Grab tensile, CD*<br>(lbs) | | | | |
| ASTM D882-83** | 13-20 lbs. | N/A: ASTM D882-83 replaced by ASTM<br>D5034 | | |
| ASTM D5034 | N/A: Current Test Method | Mean =<br>13.60 | Mean =<br>13.60 | Target Mean =<br>15.00 |
| | | Ind Min =<br>11.20 | Ind Min =<br>11.20 | Mean Min =<br>11.00 |
| | | Ind Max = | Ind Max = | Ind Min = 9.50 |
| | | 16.0 | 16.0 | |
| | | | | |
| Trap Tear, MD* (lbs) | | | | |
| ASTM D5587-15<br>Highest Peak | 3.2-7.4 lbs. | Mean = 3.47 | Mean = 3.47 | Target Mean =<br>4.00 |
| | | Ind Min = | Ind Min = | Mean Min = 2.40 |
| | | 2.73<br>Ind Max =<br>4.00 | 2.73<br>Ind Max =<br>4.00 | Ind Min = 2.00 |
| | | | | |
| Element of<br>Comparison | Predicate Device:<br>Convertors® SMS Polyolefin<br>Gown – Standard Gown<br>(K020593) | Proposed Device:<br>Cardinal Health™ Non-Reinforced Surgical<br>Gown (Representative Catalog Number 9545) | | |
| | K020593 Test Results | Test Results (3 Lots)<br>Mean (min/max) | | Specification |
| | | Sleeve | Body | |
| Trap Tear, CD* (lbs)<br>ASTM D5587-15<br>Highest Peak | 7.0-11.8 lbs. | Mean = 5.63<br>Ind Min =<br>4.67<br>Ind Max =<br>7.90 | Mean = 5.63<br>Ind Min =<br>4.67<br>Ind Max =<br>7.90 | N/A |
| Flammability (sec)<br>CPSC, Part 1610 | Class I | Class I | Class I | Class I |
| Alcohol Repellency<br>(rating)<br>NWSP 080.8.R0 (15) | >6 | Mean = 9<br>Ind Min = 8<br>Ind Max = 9 | Mean = 9<br>Ind Min = 8<br>Ind Max = 9 | Target Mean = 7<br>Mean Min = 6<br>Ind Min = 5 |
| Hydrostatic Head<br>(cm)<br>AATCC-127 | 65-92 cm | Mean =<br>89.90<br>Ind Min =<br>73.95<br>Ind Max =<br>100.98 | Mean =<br>89.90<br>Ind Min =<br>73.95<br>Ind Max =<br>100.98 | Target Mean = 70<br>Mean Min = 60<br>Ind Min = 53 |
| Water Impact (g)<br>AATCC-42 | 0.0-0.10 g | Mean = 0.10<br>Ind Min =<br>0.07<br>Ind Max =<br>0.13 | Mean = 0.10<br>Ind Min =<br>0.07<br>Ind Max =<br>0.13 | Target Mean =<br>0.10<br>Mean Max = 0.30<br>Ind 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:<br>Convertors® SMS Polyolefin Standard Gown (K020593) | Proposed Device:<br>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.