(88 days)
Not Found
No
The 510(k) summary describes a standard surgical gown made of polyolefin SMS material and focuses on its barrier performance and material properties. There is no mention of AI, ML, image processing, or any computational analysis of data that would suggest the use of such technologies.
No
The device is a surgical gown intended to protect against transfer of microorganisms and fluids, not to treat or cure a disease or condition.
No
Explanation: The device is a surgical gown, which is a protective barrier intended to prevent the transfer of microorganisms and fluids during surgical procedures. It does not perform any diagnostic function.
No
The device description clearly states it is a surgical gown made of polyolefin SMS material, which is a physical, non-software component. The testing described relates to the physical properties and barrier performance of the gown.
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 protecting surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material during surgical procedures. This is a protective barrier function, not a diagnostic function performed in vitro (outside the body).
- Device Description: The description details the materials and construction of a surgical gown, focusing on its barrier properties. It also explicitly states it's a Class II medical device under a product code related to general and plastic surgery, not IVD.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic purposes. The performance studies focus on barrier properties, material strength, and biocompatibility, not diagnostic accuracy metrics like sensitivity, specificity, or AUC.
Therefore, the Cardinal Health™ Non-Reinforced Surgical Gown is a medical device intended for protection during surgery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
FYA
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.
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 / operating room
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)
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.
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Basis weight (ASTM D3776): Mean = 1.32 oz/yd2 (Sleeve and Body), Ind Min = 1.28, Ind Max = 1.36. Specification: Target Mean = 1.30, Mean Min = 1.20, Ind Min = 1.07.
- Grab tensile, MD (ASTM D5034): Mean = 21.57 lbs (Sleeve and Body), Ind Min = 18.60, Ind Max = 23.60. Specification: N/A.
- Grab tensile, CD (ASTM D5034): Mean = 13.60 lbs (Sleeve and Body), Ind Min = 11.20, Ind Max = 16.0. Specification: Target Mean = 15.00, Mean Min = 11.00, Ind Min = 9.50.
- Trap Tear, MD (ASTM D5587-15 Highest Peak): Mean = 3.47 lbs (Sleeve and Body), Ind Min = 2.73, Ind Max = 4.00. Specification: Target Mean = 4.00, Mean Min = 2.40, Ind Min = 2.00.
- Trap Tear, CD (ASTM D5587-15 Highest Peak): Mean = 5.63 lbs (Sleeve and Body), Ind Min = 4.67, Ind Max = 7.90. Specification: N/A.
- Flammability (CPSC, Part 1610): Class I (Sleeve and Body). Specification: Class I.
- Alcohol Repellency (NWSP 080.8.R0 (15)): Mean = 9 (Sleeve and Body), Ind Min = 8, Ind Max = 9. Specification: Target Mean = 7, Mean Min = 6, Ind Min = 5.
- Hydrostatic Head (AATCC-127): Mean = 89.90 cm (Sleeve and Body), Ind Min = 73.95, Ind Max = 100.98. Specification: Target Mean = 70, Mean Min = 60, Ind Min = 53.
- Water Impact (AATCC-42): Mean = 0.10 g (Sleeve and Body), Ind Min = 0.07, Ind Max = 0.13. Specification: Target Mean = 0.10, Mean Max = 0.30, Ind Max = 1.0.
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.
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
§ 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.
0
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
1
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
2
Indications for Use
510(k) Number (if known)
Device Name
- 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) | 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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3
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.
1500 Waukegan Road Waukegan, IL 60085 www.cardinalhealth.com
510(k) SUMMARY Cardinal Health™ Non-Reinforced Surgical Gown
| Manufacturer: | Cardinal Health 200, LLC
1500 Waukegan Road
Waukegan, IL 60085 |
|-----------------------------|----------------------------------------------------------------------|
| Regulatory Affairs Contact: | Caroline Miceli
1500 Waukegan Road
Waukegan, 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) |
4
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.
5
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.
6
Side by Side Comparison Predicate Device: Convertors® SMS Polyolefin Standard Gown Proposed Device: Cardinal Health™ Non-Reinforced Surgical Gown
| Element of
Comparison | Predicate Device:
Convertors® SMS Polyolefin
Standard Gown (K020593) | Proposed Device:
Cardinal HealthTM Non-Reinforced
Surgical Gown |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended
Use/Indications for Use | Convertors® SMS Polyolefin
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. | The Cardinal HealthTM 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 HealthTM Non-
Reinforced Surgical Gowns are single
use, disposable medical devices,
provided sterile and non-sterile. |
| Directions for Use | None | Follow your facility protocol. |
| Material Composition | Polyolefin (Polypropylene)
SMS nonwoven | Polyolefin (Polypropylene) SMS
nonwoven |
| Design Features | Neck Closure: Hook and Loop
Belt Ties
Knit Cuffs
Transfer Tab | Neck Closure: Hook and Loop
Belt Ties
Knit Cuffs
Transfer Tab |
| Sterility | Sterile and non-sterile | Sterile and non-sterile |
| Use | Single Use; Disposable | Single Use; Disposable |
| Color | Light Blue | Dark Blue |
7
| Element of | Predicate Device: | Proposed Device: | ||
|---|---|---|---|---|
| Comparison | Convertors® SMS Polyolefin | |||
| Gown – Standard Gown | ||||
| (K020593) | Cardinal HealthTM Non-Reinforced Surgical | |||
| 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 | ||
| D3776 | ||||
| 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 ASTM | ||
| D5034 | ||||
| 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 ASTM | ||
| D5034 | ||||
| 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 D5587-15 | ||||
| Highest Peak | 3.2-7.4 lbs. | Mean = 3.47 | Mean = 3.47 | Target Mean = |
| 4.00 | ||||
| Ind Min = | Ind Min = | Mean Min = 2.40 | ||
| 2.73 | ||||
| Ind Max = | ||||
| 4.00 | 2.73 | |||
| Ind Max = | ||||
| 4.00 | Ind Min = 2.00 | |||
| Element of | ||||
| Comparison | Predicate Device: | |||
| Convertors® SMS Polyolefin | ||||
| Gown – Standard Gown | ||||
| (K020593) | Proposed Device: | |||
| Cardinal Health™ Non-Reinforced Surgical | ||||
| Gown (Representative Catalog Number 9545) | ||||
| K020593 Test Results | Test Results (3 Lots) | |||
| Mean (min/max) | Specification | |||
| Sleeve | Body | |||
| Trap Tear, CD* (lbs) | ||||
| ASTM D5587-15 | ||||
| Highest Peak | 7.0-11.8 lbs. | Mean = 5.63 | ||
| Ind Min = | ||||
| 4.67 | ||||
| Ind Max = | ||||
| 7.90 | Mean = 5.63 | |||
| Ind Min = | ||||
| 4.67 | ||||
| Ind 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 = 9 | ||
| Ind Min = 8 | ||||
| Ind Max = 9 | Mean = 9 | |||
| Ind Min = 8 | ||||
| Ind Max = 9 | Target Mean = 7 | |||
| Mean Min = 6 | ||||
| Ind Min = 5 | ||||
| Hydrostatic Head | ||||
| (cm) | ||||
| AATCC-127 | 65-92 cm | Mean = | ||
| 89.90 | ||||
| Ind Min = | ||||
| 73.95 | ||||
| Ind Max = | ||||
| 100.98 | Mean = | |||
| 89.90 | ||||
| Ind Min = | ||||
| 73.95 | ||||
| Ind Max = | ||||
| 100.98 | Target Mean = 70 | |||
| Mean Min = 60 | ||||
| Ind Min = 53 | ||||
| Water Impact (g) | ||||
| AATCC-42 | 0.0-0.10 g | Mean = 0.10 | ||
| Ind Min = | ||||
| 0.07 | ||||
| Ind Max = | ||||
| 0.13 | Mean = 0.10 | |||
| Ind Min = | ||||
| 0.07 | ||||
| Ind Max = | ||||
| 0.13 | Target Mean = | |||
| 0.10 | ||||
| Mean Max = 0.30 | ||||
| Ind Max = 1.0 |
8
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.
9
| 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) |
10
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.