(203 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier performance of a protective gown, with no mention of AI or ML technology.
No
The device is a protective gown intended to prevent the transfer of microorganisms, body fluids, and particulate material, not to treat or cure a disease or condition.
No
This device is a protective gown intended for barrier protection, not for diagnosing medical conditions. Its function is to prevent the transfer of microorganisms, body fluids, and particulate material.
No
The device is a physical protective gown made of laminate material, not software. The description details its physical components and performance testing related to barrier protection.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the gown is for protecting healthcare personnel and patients from the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed on samples from the body.
- Device Description: The description details the physical construction and materials of the gown. It doesn't mention any components or processes related to analyzing biological samples.
- Performance Studies: The performance studies focus on the physical barrier properties of the gown (tensile strength, tear strength, viral barrier, etc.). They do not involve any diagnostic testing metrics like sensitivity, specificity, or AUC.
- FDA Product Code and Regulation: The device is classified under FDA product code FYC and regulation 21 CFR 878.4040, which pertains to surgical apparel. IVD devices fall under different product codes and regulations (typically within 21 CFR Part 866 or 864).
In summary, the Cardinal Health™ Poly-Coated Open-Back Protective Gown is a medical device intended for personal protective equipment (PPE), not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The Cardinal Health™ Poly-Coated Open-Back Protective Gown is intended to protect health care personnel and patients from the transfer of microorganisms, body fluids, and particulate material. Not intended for use in the operating room.
The proposed Cardinal Health™ Poly-Coated Open-Back Protective Gown meets the barrier protection requirements of AAMI Level 4 per ANSI/AAMI PB70:2012. Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities, but has an open back which is non-protective.
The Cardinal Health™ Poly-Coated Open-Back Protective Gowns is a single use, disposable medical device provided non-sterile.
Product codes
QPC, FYC
Device Description
The Cardinal Health™ Poly-Coated Open-Back Protective Gown is a Class II medical device under the FDA product code of FYC, General & Plastic Surgery Panel, and Regulation 21 CFR 878.4040. The device description of the Cardinal Health™ Poly-Coated Open-Back Protective Gown is in accordance with the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued on August 1, 1993 and Guidance for Industry and FDA Staff: Premarket Notification Requirements Concerning Gowns Intended for Use in Healthcare Settings, issued on December 9, 2015.
The Cardinal Health™ Poly-Coated Open-Back Protective Gown consists of a laminate (blue spunbond polypropylene coated with polyethylene) throughout the body of the gown (including sleeves). The sleeves have a thumbhook cuff formed into the sleeve or have a knit cuff sewn onto sleeve for keeping the sleeves in place on the wearer. The collar has a neck removal feature and the belt ties are integrated into the body. These gowns are non-sterile, single use, disposable gowns that are packaged in pastic bags and/or dispenser boxes. These gowns are offered in blue and come in both Universal and XX-Large sizes.
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
health care personnel and patients. Not intended for use in the 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)
Non-Clinical Performance Testing was conducted 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.
Testing performed included:
- Basis Weight: ASTM D3776/D3776M-17. Finished Good Test Results: 43.3 (39.9 / 46.1) gsm (Mean (min/max)). Specification: 39.0 gsm min (average), 42.0 gsm target, 45.0 gsm max (average).
- Tensile Strength, CD: ASTM D5034-17. Finished Good Test Results: 14.2 (12.6 / 16.1) lb (Mean (min/max)). Specification: 5.8 lb min (individual), 3.5 lb min (average).
- Tear Strength, MD: ASTM D5587-15. Finished Good Test Results: 6.0 (4.4 / 7.5) lb (Mean (min/max)). Specification: 6.7 lb min (individual), 2.8 lb min (average).
- Flammability: CPSC, Part 1610. Finished Good Test Results: Class 1. Specification: Class 1.
- Hydrostatic head: AATCC 127:2017. Finished Good Test Results: >130 (130 / >130) cmH20, >51 (51 />51) inH20 (Mean (min/max)). Specification: 140 cmH20 target, 100 cmH20 min (individual).
- Viral barrier (resistance to bacteriophage Phi-X174): ASTM F1671-13. Finished Good Test Results: Pass. Specification: Pass.
- Liquid Barrier Performance Classification Properties: Performed in accordance with ASTM F1671 using 3 lots and 32 samples per lot in each critical zone area (body/sleeve and heat sealed seams). All areas tested meet Level 4 performance requirements, which is the highest standardized level of barrier performance. The gown meets AAMI Level 4 per ANSI/AAMI PB70:2012.
- Biocompatibility: Tested per ISO-10993-1, ISO 10993-5:2009, and ISO 10993-10:2010. The gown is non-cytotoxic, non-irritating, and non-sensitizing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found. Performance metrics for barrier properties (Pass/Fail, quantitative values for physical tests) are provided in the "Summary of Performance Studies".
Predicate Device(s)
K952115 Kool-Gard Backless Protective Gown
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 8, 2021
Cardinal Health 200, LLC Caroline Miceli Manager, Regulatory Affairs 3651 Birchwood Drive Waukegan, Illinois 60085
Re: K182830
Trade/Device Name: Cardinal HealthTM Poly-Coated Open-Back Protective Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: QPC
Dear Caroline Miceli:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated April 26, 2019. Specifically, FDA is updating this SE Letter because FDA has created a new product code to better categorize your device technology.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Dr. Ryan Ortega, Acting Assistant Director, Office of Surgical and Infection Control Devices, at 240-402-2303 or Ryan.ortega@fda.hhs.gov.
Sincerely,
Bifeng Qian -S
For Ryan Ortega, PhD Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
April 26, 2019
Cardinal Health 200, LLC Caroline Miceli Manager, Regulatory Affairs 3651 Birchwood Drive Waukegan, Illinois 60085
Re: K182830
Trade/Device Name: Cardinal Health™ Poly-Coated Open-Back Protective Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYC Dated: March 29, 2019 Received: April 3, 2019
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
2
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray lii III -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K182830
Device Name
Cardinal HealthTM Poly-Coated Open-Back Protective Gown
Indications for Use (Describe)
The Cardinal Health™ Poly-Coated Open-Back Protective Gown is intended to protect health care personnel and patients from the transfer of microorganisms, body fluids, and particulate material. Not intended for use in the operating room.
The proposed Cardinal Health™ Poly-Coated Open-Back Protective Gown meets the barrier protection requirements of AAMI Level 4 per ANSI/AAMI PB70:2012. Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities, but has an open back which is non-protective.
The Cardinal Health™ Poly-Coated Open-Back Protective Gowns is a single use, disposable medical device provided non-sterile.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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4
Image /page/4/Picture/1 description: The image features the logo for Cardinal Health. The logo consists of a stylized red bird-like design above the company name. The text "CardinalHealth" is written in a bold, sans-serif font, with the first letter capitalized and the rest in lowercase.
3651 Birchwood Drive Waukegan, IL 60085 www.cardinalhealth.com
510(k) SUMMARY Cardinal Health™ Poly-Coated Open-Back Protective Gown
| Manufacturer: | Cardinal Health 200, LLC
3651 Birchwood Drive
Waukegan, IL 60085 |
|-----------------------------|---------------------------------------------------------------------------------|
| Regulatory Affairs Contact: | Caroline Miceli
300 South Riverside Plaza
Suite 2010
Chicago, IL 60606 |
| Telephone Number: | (312) 270-2013 |
| Fax Number: | (312) 775-9324 |
| Date Summary Prepared: | April 25, 2019 |
| Trade Name: | Cardinal Health™ Poly-Coated Open-Back Protective Gown |
| Regulation Number: | 21 CFR §878.4040 |
| Device Class: | Class II |
| Regulation Name: | Surgical Apparel |
| Common/Classification Name: | Surgical Isolation Gown |
| Product Code: | FYC |
| Predicate Device: | Kool-Gard Backless Protective Gown (K952115) |
5
Description
The Cardinal Health™ Poly-Coated Open-Back Protective Gown is a Class II medical device under the FDA product code of FYC, General & Plastic Surgery Panel, and Regulation 21 CFR 878.4040. The device description of the Cardinal Health™ Poly-Coated Open-Back Protective Gown is in accordance with the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes, issued on August 1, 1993 and Guidance for Industry and FDA Staff: Premarket Notification Requirements Concerning Gowns Intended for Use in Healthcare Settings, issued on December 9, 2015.
The Cardinal Health™ Poly-Coated Open-Back Protective Gown consists of a laminate (blue spunbond polypropylene coated with polyethylene) throughout the body of the gown (including sleeves). The sleeves have a thumbhook cuff formed into the sleeve or have a knit cuff sewn onto sleeve for keeping the sleeves in place on the wearer. The collar has a neck removal feature and the belt ties are integrated into the body. These gowns are non-sterile, single use, disposable gowns that are packaged in pastic bags and/or dispenser boxes. These gowns are offered in blue and come in both Universal and XX-Large sizes.
Indications for Use
The Cardinal Health™ Poly-Coated Open-Back Protective Gown is intended to protect health care personnel and patients from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. The proposed (subject device) Cardinal Health™ Poly-Coated Open-Back Protective Gown meets the barrier protection requirements of AAMI Level 4 per ANSI/AAMI PB70:2012, Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities, but has an open back which is non-protective. The Cardinal Health™ Poly-Coated Open-Back Protective Gown is a single use, disposable medical device provided non-sterile.
6
Technological Characteristics
Shown below is the technological characteristics comparison of the subject device and the
predicate device.
| Element of
Comparison | Predicate Device:
K952115 Kool-Gard Backless Protective
Gown | Subject Device:
Cardinal Health™ Poly-Coated Open-
Back Protective Gown | Comparison |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for Use | This device is intended for non-sterile use only, and is not intended for use in the Operating
Room. It is intended for use in areas where there
is the potential for medium to heavy fluid contact
in the front. | The proposed Cardinal Health™ Poly-Coated
Open-Back Protective Gown is intended to
protect health care personnel and patients from
the transfer of microorganisms, body fluids
and particulate material. Not intended for use
in the operating room
The proposed Cardinal Health™ Poly-Coated
Open-Back Protective Gown meets the barrier
protection requirements of AAMI Level 4 per
ANSI/AAMI PB70:2012, Liquid Barrier
Performance and Classification of Protective
Apparel and Drapes Intended for Use in
Health Care Facilities, but has an open back
which is non-protective.
The Cardinal Health™ Poly-Coated Open-
Back Protective Gown is a single use,
disposable medical device provided non-
sterile. | Similar |
| Barrier Protection
Level | ANSI/AAMI PB70:2012, Liquid Barrier
Performance and Classification of Protective
Apparel and Drapes Intended for Use in Health
Care Facilities was not in effect at this time. | AAMI Level 4 per ANSI/AAMI PB70:2012,
Liquid Barrier Performance and
Classification of Protective Apparel and
Drapes Intended for Use in Health Care
Facilities, but has an open back which is non-
protective. | Different |
| Directions for Use | None | None | Same |
| Material
Composition | Nonwoven polypropylene laminated with either
polypropylene or polyethylene film | Laminate (spunbond polypropylene coated
with polyethylene) | Similar |
| Design Features | Elastic at the cuff for keeping the sleeves in
place on the wearer
Belt Ties | Thumbhook cuff formed into sleeve or knit
cuff sewn onto sleeve for keeping the sleeves
in place on the wearer
Belt Ties integrated into body
Neck removal feature | Same |
Technological Characteristics Comparison Table
7
| Sterility | Non-sterile | Non-sterile | Same |
|---|---|---|---|
| Use | Single Use; Disposable | Single Use; Disposable | Same |
| Color and Size | Blue or Yellow | ||
| Size: Universal | Blue | ||
| Size: Universal and XX-Large | Similar |
Non-Clinical Performance Testing
The proposed 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 table below contains a summary of the non-clinical performance testing of the device and it is compared to the predicate device. A complete listing of the name of each standard or test method used in this submission is also included after the table.
| Summary of Non-Clinical Performance Testing | |||
|---|---|---|---|
| Element of Comparison | Predicate Device: | ||
| K952115 | Subject Device: | ||
| Kool-Gard Backless | |||
| Protective Gown | Cardinal HealthTM Poly-Coated Open-Back Protective Gown | ||
| Finished Good Test Results: | |||
| Mean (min/max) | |||
| Sleeve and Body material | Specification | ||
| Basis Weight | |||
| IST 130.0-70 (R82) ** | 1.5 - 2.0 oz/yd2 | ||
| (50.9 - 67.8 gsm) | N/A: ASTM D3776/D3776M-09 | ||
| (2013) used in place of IST 130.0- | |||
| 70 (R82) | N/A | ||
| ASTM D3776/D3776M-17 | N/A: Current method | ||
| not available at time of | |||
| predicate | 43.3 (39.9 / 46.1) gsm | 39.0 gsm min (average) | |
| 42.0 gsm target | |||
| 45.0 gsm max (average) | |||
| Tensile Strength, CD * | |||
| ASTM D1682-64 ** | > 5 lb/in | N/A: ASTM D5034-09 (2013) used | |
| in place of ASTM D1682-64 | N/A |
8
| Summary of Non-Clinical Performance Testing | |||
|---|---|---|---|
| Element of Comparison | Predicate Device: | ||
| K952115 | Subject Device: | Specification | |
| Kool-Gard Backless | |||
| Protective Gown | Cardinal Health™ Poly-Coated Open-Back Protective Gown | ||
| Finished Good Test Results: | |||
| Mean (min/max) | |||
| Sleeve and Body material | |||
| ASTM D5034-17 | N/A: Current method | ||
| not available at time of | |||
| predicate | 14.2 (12.6 / 16.1) lb | 5.8 lb min (individual) | |
| 3.5 lb min (average) | |||
| Tear Strength, MD * | |||
| ASTM D1117-77 ** | > 6 lb | N/A: ASTM D5587-15 used in | |
| place of ASTM D1117-77 | N/A | ||
| ASTM D5587-15 | N/A: Current method | ||
| not available at time of | |||
| predicate | 6.0 (4.4 / 7.5) lb | 6.7 lb min (individual) | |
| 2.8 lb min (average) | |||
| Flammability | |||
| CPSC, Part 1610 | Not reported in 510k | ||
| Summary | Class 1 | Class 1 | |
| Hydrostatic head | |||
| AATCC 127-1985 ** | |||
| (w/synthetic blood) | > 45 inH20 material | ||
| 8.0 - 10.11 inH20 | |||
| (seam) | N/A: AATCC 127:2014 used in | ||
| place of AATCC 127:1985 | N/A | ||
| AATCC 127:2017 | N/A: Current method | ||
| not available at time of | |||
| predicate | >130 (130 / >130) cmH20 |
51 (51 />51) inH20 | 140 cmH20 target
100 cmH20 min
(individual) |
| Viral barrier (resistance to
bacteriophage Phi-X174) | | | |
| ASTM F1671-13 | N/A: Current method
not available at time of
predicate | Pass | Pass |
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 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 米 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; subject device was tested on current standards.
9
| Summary of Non-Clinical Performance Testing | ||
|---|---|---|
| Element of Comparison | Predicate Device: | |
| Kool-Gard Backless Protective | ||
| Gown (K952115) | Subject Device: | |
| Cardinal Health™ Poly-Coated Open- | ||
| Back Protective Gown | ||
| Liquid Barrier | ||
| Performance | ||
| Classification Properties | PB70 Performance Standard | |
| was not available at the time of | ||
| the predicate submission. | ||
| Predicate device tested to | ||
| AATCC 127-1985 Hydrostatic | ||
| Pressure (with synthetic blood) | ||
| to establish protection level for | ||
| medium to heavy fluid contact | ||
| in the front. | All areas tested meet Level 4 | |
| performance requirements (ASTM | ||
| F1671), which is the highest | ||
| standardized level of barrier | ||
| performance | ||
| The Cardinal Health™ Poly-Coated | ||
| Open-Back Protective Gown meets the | ||
| barrier protection requirements of AAMI | ||
| Level 4 per ANSI/AAMI PB70:2012, | ||
| Liquid Barrier Performance and | ||
| Classification of Protective Apparel and | ||
| Drapes Intended for Use in Health Care | ||
| Facilities, but has an open back which is | ||
| non-protective. Testing was performed | ||
| in accordance with ASTM F1671 using | ||
| 3 lots and 32 samples per lot in each | ||
| critical zone area. The critical zone areas | ||
| tested were the body or sleeve (same | ||
| material) and the heat sealed seam(s). | ||
| Biocompatibility | Certified, the materials used in | |
| the device are the same as other | ||
| legally marketed devices for | ||
| same intended use. | Under the conditions of each study, the | |
| Cardinal Health™ Poly-Coated Open- | ||
| Back Protective Gown is non-cytotoxic, | ||
| non-irritating, and is non-sensitizing and | ||
| has met the requirements per ISO- | ||
| 10993-1. | ||
| Sterilization Modality | None, non-sterile | None, non-sterile |
10
Test Standards
| Standard Number | Standards Organization | Standards Title | Version | Date |
|---|---|---|---|---|
| AAMI PB70:2012 | Association for the | |||
| Advancement of | ||||
| Medical | ||||
| Instrumentation | Liquid Barrier Performance | |||
| Classification of Protective Apparel and | ||||
| Drapes Intended for Use in Health Care | ||||
| Facilities | 2012 | 8/1/2012 | ||
| ASTM- | ||||
| F1671/F1671M-13 | ASTM | |||
| International | 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 | 2013 | 2013 | ||
| ASTM | ||||
| D3776/D3776M-17 | ASTM | |||
| International | Test Methods for Mass Per Unit Area | |||
| (Weight) of Woven Fabric | 2017 | 2017 | ||
| ASTM D5034-17 | ASTM | |||
| International | Standard Test Method for Breaking | |||
| Strength and Elongation of Textile | ||||
| Fabrics (Grab Test) | 2017 | 2017 | ||
| ASTM D5587-2015 | ASTM | |||
| International | Standard Test Method for Tearing | |||
| Strength of Fabrics by Trapezoid | 2015 | 2015 | ||
| AATCC 127-2017 | American | |||
| Association of | ||||
| Textile Chemist | ||||
| and Colorist | Water Resistance: Hydrostatic Pressure | |||
| Test | 2017 | 2017 | ||
| (CPSC), Part 1610 | Consumer | |||
| Product Safety | ||||
| Commission | Standard for the Flammability of | |||
| Clothing Textiles | 2008 | 2008 | ||
| ISO 10993- | ||||
| 1:2009/(R)2013 | International | |||
| Organization of | ||||
| Standardization | Biological Evaluation of Medical | |||
| Devices- Part 1: Evaluation and testing | ||||
| within a risk management process | 2013 | 10/15/2009 | ||
| ISO 10993-5:2009 | International | |||
| Organization of | ||||
| Standardization | Biological Evaluation of Medical | |||
| Devices- Part 5: Tests for In-Vitro | ||||
| Cytotoxicity | 2009 | 6/1/2009 | ||
| ISO 10993-10:2010 | International | |||
| Organization of | ||||
| Standardization | Biological Evaluation of Medical | |||
| Devices- Part 10: Tests for irritation and | ||||
| delayed-type hypersensitivity | 2010 | 8/1/2010 |
Conclusion
The Cardinal Health™ Poly-Coated Open-Back Protective Gown is as safe, as effective and performs as well as or better than the legally marketed predicate device, Kool-Gard Backless Protective Gown (K952115).