(203 days)
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.
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.
The document describes the non-clinical performance testing of the Cardinal Health™ Poly-Coated Open-Back Protective Gown. It evaluates the device against specific acceptance criteria and details the study methods used.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Element of Comparison | Specification (Acceptance Criteria) | Reported Device Performance (Mean (min/max)) |
|---|---|---|
| Basis Weight (ASTM D3776/D3776M-17) | 39.0 gsm min (average) 42.0 gsm target 45.0 gsm max (average) | 43.3 (39.9 / 46.1) gsm (Sleeve and Body material) |
| Tensile Strength, CD (ASTM D5034-17) | 5.8 lb min (individual) 3.5 lb min (average) | 14.2 (12.6 / 16.1) lb |
| Tear Strength, MD (ASTM D5587-15) | 6.7 lb min (individual) 2.8 lb min (average) | 6.0 (4.4 / 7.5) lb |
| Flammability (CPSC, Part 1610) | Class 1 | Class 1 |
| Hydrostatic Head (AATCC 127:2017) | 140 cmH20 target 100 cmH20 min (individual) | >130 (130 / >130) cmH20 >51 (51 / >51) inH20 |
| Viral barrier (ASTM F1671-13) | Pass | Pass |
| Liquid Barrier Performance Classification Properties (ANSI/AAMI PB70:2012 / ASTM F1671) | Meets AAMI Level 4 performance requirements | All areas tested meet Level 4 performance requirements |
| Biocompatibility | Non-cytotoxic, non-irritating, non-sensitizing per ISO-10993-1 | Non-cytotoxic, non-irritating, non-sensitizing and met requirements per ISO-10993-1 |
2. Sample size used for the test set and the data provenance
- Liquid Barrier Performance Classification Properties: Testing was performed using 3 lots and 32 samples per lot in each critical zone area (body or sleeve, and heat sealed seam(s)).
- Other tests (Basis Weight, Tensile Strength, Tear Strength, Hydrostatic Head): The document provides mean and min/max values, but a specific sample size for these individual tests beyond the "Finished Good Test Results" is not explicitly stated.
- Data Provenance: The document implies that the testing was conducted internally by the manufacturer, Cardinal Health, or by a contracted lab. The data is presented as "Finished Good Test Results" for the "Subject Device: Cardinal Health™ Poly-Coated Open-Back Protective Gown." This data would be considered prospective as it's generated specifically for the device submission. The country of origin for the data is not specified, but the submission is to the U.S. FDA by a company based in Illinois, USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The tests described are non-clinical performance tests that use standardized methodologies (e.g., ASTM, AATCC, ISO standards) to measure physical and barrier properties. These types of tests do not typically involve human expert interpretation or "ground truth" in the same way clinical studies or diagnostic device evaluations would. The "ground truth" is established by the test method itself and the specified performance criteria. Therefore, no human experts were used to establish ground truth for this test set in the context of diagnostic interpretation.
4. Adjudication method for the test set
Not applicable. As noted above, these are non-clinical, objective performance tests following standardized methods, not subjective clinical assessments requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a submission for a protective gown, which is a physical medical device, not an AI-powered diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance is not relevant or presented.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used
The ground truth for the non-clinical performance tests is based on predefined objective standards and specifications (e.g., AAMI Level 4 for barrier protection, specific tensile strength values, flammability classes). These standards define what constitutes a "pass" or "fail" for each characteristic.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model, and therefore there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
{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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
* DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
PSC Publishing Services (301) 443-6740 EF
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
{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, LLC3651 Birchwood DriveWaukegan, IL 60085 |
|---|---|
| Regulatory Affairs Contact: | Caroline Miceli300 South Riverside PlazaSuite 2010Chicago, 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 ofComparison | Predicate Device:K952115 Kool-Gard Backless ProtectiveGown | 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 OperatingRoom. It is intended for use in areas where thereis the potential for medium to heavy fluid contactin the front. | The proposed Cardinal Health™ Poly-CoatedOpen-Back Protective Gown is intended toprotect health care personnel and patients fromthe transfer of microorganisms, body fluidsand particulate material. Not intended for usein the operating roomThe proposed Cardinal Health™ Poly-CoatedOpen-Back Protective Gown meets the barrierprotection requirements of AAMI Level 4 perANSI/AAMI PB70:2012, Liquid BarrierPerformance and Classification of ProtectiveApparel and Drapes Intended for Use inHealth Care Facilities, but has an open backwhich is non-protective.The Cardinal Health™ Poly-Coated Open-Back Protective Gown is a single use,disposable medical device provided non-sterile. | Similar |
| Barrier ProtectionLevel | ANSI/AAMI PB70:2012, Liquid BarrierPerformance and Classification of ProtectiveApparel and Drapes Intended for Use in HealthCare Facilities was not in effect at this time. | AAMI Level 4 per ANSI/AAMI PB70:2012,Liquid Barrier Performance andClassification of Protective Apparel andDrapes Intended for Use in Health CareFacilities, but has an open back which is non-protective. | Different |
| Directions for Use | None | None | Same |
| MaterialComposition | Nonwoven polypropylene laminated with eitherpolypropylene or polyethylene film | Laminate (spunbond polypropylene coatedwith polyethylene) | Similar |
| Design Features | Elastic at the cuff for keeping the sleeves inplace on the wearerBelt Ties | Thumbhook cuff formed into sleeve or knitcuff sewn onto sleeve for keeping the sleevesin place on the wearerBelt Ties integrated into bodyNeck 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 YellowSize: Universal | BlueSize: 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 BacklessProtective 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 methodnot available at time ofpredicate | 43.3 (39.9 / 46.1) gsm | 39.0 gsm min (average)42.0 gsm target45.0 gsm max (average) |
| Tensile Strength, CD * | |||
| ASTM D1682-64 ** | > 5 lb/in | N/A: ASTM D5034-09 (2013) usedin 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 BacklessProtective Gown | Cardinal Health™ Poly-Coated Open-Back Protective GownFinished Good Test Results:Mean (min/max)Sleeve and Body material | ||
| ASTM D5034-17 | N/A: Current methodnot available at time ofpredicate | 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 inplace of ASTM D1117-77 | N/A |
| ASTM D5587-15 | N/A: Current methodnot available at time ofpredicate | 6.0 (4.4 / 7.5) lb | 6.7 lb min (individual)2.8 lb min (average) |
| Flammability | |||
| CPSC, Part 1610 | Not reported in 510kSummary | Class 1 | Class 1 |
| Hydrostatic head | |||
| AATCC 127-1985 **(w/synthetic blood) | > 45 inH20 material8.0 - 10.11 inH20(seam) | N/A: AATCC 127:2014 used inplace of AATCC 127:1985 | N/A |
| AATCC 127:2017 | N/A: Current methodnot available at time ofpredicate | >130 (130 / >130) cmH20>51 (51 />51) inH20 | 140 cmH20 target100 cmH20 min(individual) |
| Viral barrier (resistance tobacteriophage Phi-X174) | |||
| ASTM F1671-13 | N/A: Current methodnot available at time ofpredicate | 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 ProtectiveGown (K952115) | Subject Device:Cardinal Health™ Poly-Coated Open-Back Protective Gown |
| Liquid BarrierPerformanceClassification Properties | PB70 Performance Standardwas not available at the time ofthe predicate submission.Predicate device tested toAATCC 127-1985 HydrostaticPressure (with synthetic blood)to establish protection level formedium to heavy fluid contactin the front. | All areas tested meet Level 4performance requirements (ASTMF1671), which is the higheststandardized level of barrierperformanceThe Cardinal Health™ Poly-CoatedOpen-Back Protective Gown meets thebarrier protection requirements of AAMILevel 4 per ANSI/AAMI PB70:2012,Liquid Barrier Performance andClassification of Protective Apparel andDrapes Intended for Use in Health CareFacilities, but has an open back which isnon-protective. Testing was performedin accordance with ASTM F1671 using3 lots and 32 samples per lot in eachcritical zone area. The critical zone areastested were the body or sleeve (samematerial) and the heat sealed seam(s). |
| Biocompatibility | Certified, the materials used inthe device are the same as otherlegally marketed devices forsame intended use. | Under the conditions of each study, theCardinal Health™ Poly-Coated Open-Back Protective Gown is non-cytotoxic,non-irritating, and is non-sensitizing andhas 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 theAdvancement ofMedicalInstrumentation | Liquid Barrier PerformanceClassification of Protective Apparel andDrapes Intended for Use in Health CareFacilities | 2012 | 8/1/2012 |
| ASTM-F1671/F1671M-13 | ASTMInternational | Standard Test Method for Resistance ofMaterials Used in Protective Clothing toPenetration by Blood-Borne PathogensUsing Phi-X174 BacteriophagePenetration as a Test System | 2013 | 2013 |
| ASTMD3776/D3776M-17 | ASTMInternational | Test Methods for Mass Per Unit Area(Weight) of Woven Fabric | 2017 | 2017 |
| ASTM D5034-17 | ASTMInternational | Standard Test Method for BreakingStrength and Elongation of TextileFabrics (Grab Test) | 2017 | 2017 |
| ASTM D5587-2015 | ASTMInternational | Standard Test Method for TearingStrength of Fabrics by Trapezoid | 2015 | 2015 |
| AATCC 127-2017 | AmericanAssociation ofTextile Chemistand Colorist | Water Resistance: Hydrostatic PressureTest | 2017 | 2017 |
| (CPSC), Part 1610 | ConsumerProduct SafetyCommission | Standard for the Flammability ofClothing Textiles | 2008 | 2008 |
| ISO 10993-1:2009/(R)2013 | InternationalOrganization ofStandardization | Biological Evaluation of MedicalDevices- Part 1: Evaluation and testingwithin a risk management process | 2013 | 10/15/2009 |
| ISO 10993-5:2009 | InternationalOrganization ofStandardization | Biological Evaluation of MedicalDevices- Part 5: Tests for In-VitroCytotoxicity | 2009 | 6/1/2009 |
| ISO 10993-10:2010 | InternationalOrganization ofStandardization | Biological Evaluation of MedicalDevices- Part 10: Tests for irritation anddelayed-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).
§ 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.