(308 days)
ProTEC-USA EZDoff Gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. The ProTEC-USA EZDoff Gown is a single use, disposable gown provided non-sterile. The back of the gown is open and non-protective. The gown is not intended for use in the operating room.
The ProTEC-USA EZDoff Gown is constructed of 41 gsm blue polyolefin (Polyethylene) film offered in one universal size. The body of the gown is provided with belt ties that are constructed of the same 41 gsm blue polyolefin (Polyethylene) film. The sleeves of the gown are sealed using a heat-sealing method.
The document describes the acceptance criteria and study results for the ProTEC-USA EZDoff Gown, a non-sterile, single-use protective medical gown.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Method (Reference Standard) | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Flammability (CPSC, 16 CFR Part 1610) | Average burn time ≥ 3.5s | Pass (Meets Class 1 Flammability) |
| Hydrostatic Pressure (AAMI PB70:2012) | AATCC 127 ≥ 50 cm, AQL of 4.0 | Pass (Meets Level 3 liquid barrier requirements) |
| Water Impact (AAMI PB70:2012) | AATCC 42 ≤ 1.0g, AQL of 4.0 | Pass (Meets Level 3 liquid barrier requirements) |
| Breaking Strength (ASTM D5034) | The standard does not include an acceptance criteria. | 52N (Machine Direction), 41N (Transverse Direction) |
| Tearing Strength (ASTM D5587) | The standard does not include an acceptance criteria. | 8N (Machine Direction), 22N (Transverse Direction) |
| Linting (ISO 9073-10) | The standard does not include an acceptance criteria. | Log10 < 4 |
| Air Permeability (ASTM C522) | The standard does not include an acceptance criteria. | 0 ft³/min/ft² |
| Cytotoxicity (ISO 10993-5:2009) | Under the conditions of the studies ISO 10993-5:2009, the proposed device is non-cytotoxic. | Pass |
| Sensitization (ISO 10993-10:2010) | Under the conditions of the studies: ISO 10993-10:2010, the proposed device is non-sensitizing. | Pass |
| Irritation (ISO 10993-10:2010) | Under the conditions of the studies: ISO 10993-10:2010, the proposed device is non-irritating. | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size:
- For Hydrostatic Pressure and Water Impact tests, "three (3) nonconsecutive lots" were utilized.
- For Breaking Strength and Tearing Strength tests, "three (3) nonconsecutive lots" were utilized.
- For Linting, "three (3) nonconsecutive lots" were utilized.
- The specific number of units tested within each lot is not provided.
- For Flammability, Cytotoxicity, Sensitization, and Irritation, a specific sample size is not explicitly stated beyond "Under the conditions of the studies."
- Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective. These were non-clinical, lab-based tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable as the document describes non-clinical testing of a medical gown. The "ground truth" here refers to objective measurements against established international and national standards, not expert medical opinion.
4. Adjudication Method for the Test Set:
This information is not applicable as the tests were objective measurements against predefined standards, not subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. without AI Assistance:
This information is not applicable. The device is a protective medical gown, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This information is not applicable. The device is a physical medical gown, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for the performance evaluation of the ProTEC-USA EZDoff Gown was established through objective measurements against established international and national standards (e.g., AAMI PB70:2012, CPSC 16 CFR Part 1610, ASTM D5034, ASTM D5587, ISO 9073-10, ASTM C522, ISO 10993-5, ISO 10993-10). These standards define the acceptable performance characteristics for medical gowns and materials.
8. The Sample Size for the Training Set:
This information is not applicable as the document describes non-clinical testing of a physical medical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there was no training set for an algorithm. The "ground truth" for evaluating the gown's performance was derived from the aforementioned standardized test methods.
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December 15, 2021
Cadillac Products, Inc. % Dennis Gucciardo Partner Morgan Lewis & Bockius LLP 1111 Pennsylvania Ave Washington, District of Columbia 20004-2541
Re: K210405
Trade/Device Name: ProTEC-USA EZDoff Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: OPC Dated: November 15, 2021 Received: November 15, 2021
Dear Dennis Gucciardo:
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
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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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
- 79 -
510(k) Number (if known) K210405
Device Name ProTEC-USA EZDoff Gown
Indications for Use (Describe)
ProTEC-USA EZDoff Gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. The ProTEC-USA EZDoff Gown is a single use, disposable gown provided non-sterile. The back of the gown is open and non-protective. The gown is not intended for use in the operating room.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| x Over-The-Counter Use (21 CFR 801 Subpart C) |
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K210405
510(k) SUMMARY
Cadillac Product Inc.'s ProTEC USA EZDoff Gown
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:
Cadillac Products, Inc. 5800 Crooks Road Suite 100 Troy, MI 48098
Phone: (248) 813-8200 Fax: (248) 813-8282
Contact Person: Andrew Stone Date Summary Prepared: December 11, 2021
Application Correspondent
Dennis C. Gucciardo, Partner
Morgan, Lewis & Bockius, LLP 1111 Pennsylvania Ave. NW Washington, DC 20004-2541
Phone: (202) 739-5278
Name of Device and Name:
ProTEC-USA EZDoff Gown
Common or Usual Name:
Singe Use/Non-Sterile Open Back Protective Gowns
Classification Name:
Class II, 21 CFR § 878.4040; Product Code QPC
Predicate Device
ValueCare®Open Back Protective Gown (K160337)
Intended Use / Indications for Use
ProTEC-USA EZDoff Gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. The ProTEC-USA EZDoff Gown is a single use, disposable gown provided non-sterile. The back of the gown is open and nonprotective. The gown is not intended for use in the operating room.
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Device Description
The ProTEC-USA EZDoff Gown is constructed of 41 gsm blue polyolefin (Polyethylene) film offered in one universal size. The body of the gown is provided with belt ties that are constructed of the same 41 gsm blue polyolefin (Polyethylene) film. The sleeves of the gown are sealed using a heat-sealing method.
Comparison of Technological Characteristics with the Predicate Device
The technological characteristics of the ProTEC-USA EZDoff Gown are nearly identical to the cleared ValueCare®Open Back Protective Gown (K160337). Both devices are made from extruded plastic film and include sleeves that are sealed with a heat treatment. A summary of the technologies and characteristics between the predicate device and the ProTEC-USA EZDoff Gown are provided in the table below.
| Predicate Device:ValueCare® Open BackProtective Gown (K160337) | Proposed Device: ProTEC-USA EZDoff Gown(K210405) | Comparison | |
|---|---|---|---|
| Intended Use /Indications forUse | These gowns are intendedtoprotect health care patientsand health care personnelfrom the transferofmicroorganisms, body fluidsand particulate material. Theback of the gown is open andnon- protective. They are notintended for use in theoperating room. | ProTEC-USA EZDoff Gownis intended to protect healthcare patients and healthcare personnel from thetransfer of microorganisms,body fluids and particulatematerial. The ProTEC-USAEZDoff Gown is a singleuse, disposable gownprovided non-sterile. Theback of the gown is openand non-protective. Thegown is not intended for usein the operating room. | Same |
| Design | Design includes open back,thumbloops,backperforation for easy removaland waist tie | Design includes open back,thumbloops,backperforation for easy removaland waist tie | Same |
| MaterialComposition | Made from extruded plasticfilm | Made from extruded plasticfilm(Polyolefin(Polyethylene) film) | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Use | Single use; disposable | Single use; disposable | Same |
| Color | Blue | Blue | Same |
| Labeling Claims | These gowns are intendedtoprotect health care patientsand health care personnelfrom the transferofmicroorganisms, body fluidsand particulate material. Theback of the gown is open andnon- protective. They are notintended for use in theoperating room.Non-Sterile | These gowns are intended toprotect health care patientsand health care personnelfrom the transferofmicroorganisms, body fluidsand particulate material. Theback of the gown is open andnon- protective. They are notintended for use in theoperating room.Non-Sterile | Same |
| - Not Made withNatural RubberLatexMeets ANSI/AAMIPB70: 2012 Level 3Open Back Non-protectiveSingleUse,Disposable | - Not Made withNatural RubberLatexMeets ANSI/AAMIPB70: 2012 Level 3Open Back Non-protectiveSingle Use,Disposable | ||
| Flammability16 CFR 1610 | Meets Class 1 "normalflammability " in accordanceto 16 CFR Part 1610 | Meets Class 1 "normalflammability " in accordanceto 16 CFR Part 1610 | Same |
| Liquid BarrierPerformanceClassificationProperties | Device was tested inaccordance with AAMIPB70:2012 and meets Level3 requirements for anisolation gown. | Device was tested inaccordance with AAMIPB70:2012 and meets Level3 requirements for anisolation gown. | Same |
| Biocompatibility | PassISO 10993-1 | PassISO 10993-1 | Same |
| TearingStrength /Resistance | Not Reported | 8N (Machine Direction)22N (Transverse Direction) | Not reported forcomparison |
| Lint | Not Reported | Log10<4 | Not reported forcomparison |
| Air Permeability | Not Reported | 0 ft³/min/ft² | Not reported forcomparison |
| Tensile Strength | Not Reported | 52N (Machine Direction)41N (Transverse Direction) | Not reported forcomparison |
| SterilizationModality | None(Non-Sterile) | None(Non-Sterile) | Same |
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Summary of Non-Clinical Testing Performed on the Proposed Device
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Flammability | Test performed inaccordance with(CPSC), 16 CFRPart 1610 | Average burn time ≥3.5s | PassMeets Class 1Flammability. |
| Hydrostatic Pressure | Test performed inaccordance with AAMIPB70:2012 utilizingthree (3)nonconsecutive lots. | AATCC 127 ≥ 50 cmAQL of 4.0 | PassMeets Level 3 liquidbarrier requirements. |
| Water Impact | Test performed inaccordance with AAMIPB70:2012 utilizingthree (3)nonconsecutive lots. | AATCC 42 ≤ 1.0gAQL of 4.0 | PassMeets Level 3 liquidbarrier requirements. |
| Breaking strength | Test performed inaccordance withASTM D5034utilizing three (3)nonconsecutivelots. | The standard does notinclude an acceptancecriteria. | The test resultsreported values were52N (MachineDirection), 41N(TransverseDirection). |
| Tearing strength | Test performed inaccordance withASTM D5587 | The standard does notinclude an acceptancecriteria. | The test resultsreportedvalues were |
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| utilizing three(3)nonconsecutivelots. | 8N (MachineDirection), 22N(TransverseDirection). | ||
|---|---|---|---|
| Linting | Test performed inaccordance with ISO9073-10 utilizing three(3) nonconsecutive lots. | The standard does notinclude an acceptancecriteria. | The test resultsreported value was$Log_{10}<4$ . |
| Air Permeability | Test performed inaccordance with ASTMC522. | The standard does notinclude an acceptancecriteria. | The test resultsreported value was 0 ft3/min/ft2 |
Biocompatibility Testing Performed on the Proposed Device
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Cytotoxicity | Test performed inaccordance with ISO10993-5:2009. | Under the conditionsof the studies ISO10993-5:2009, the proposeddevice is non-cytotoxic. | Pass |
| Sensitization | Test performed inaccordance with ISO10993-10:2010. | Under the conditionsof the studies: ISO10993-10:2010, the proposeddevice is non-sensitizing | Pass |
| Irritation | Test performed inaccordance with ISO10993-10:2010. | Under the conditionsof the studies: ISO10993-10:2010, the proposeddevice is non-irritating. | Pass |
The EZDoff Gown was tested and conformed to the following standards and requirements:
| StandardNumber | StandardsOrganization | Standards Title | Version | Date |
|---|---|---|---|---|
| ASTM F2407 | American Societyfor Testing &Materials | Standard Specification forSurgical Gowns Intended for Usein Healthcare Facilities | 2013 | May 2013 |
| AAMIPB70:2012 | AmericanNational Standard | Liquid Barrier PerformanceClassification of ProtectiveApparel and Drapes Intended foruse in Health Care Facilities | 2012 | 6/21/2012 |
| (CPSC), 16 CFRPart 1610 | ConsumerProduct SafetyCommission | Standard for Flammability ofClothing Textiles | 2008 | 3/25/2008 |
| ISO 10993-1:2009/(R)2013 | InternationalOrganization ofStandardization | Biological Evaluation of MedicalDevices - Part 1: Evaluation andtesting with a risk managementprocess | 2013 | 10/15/2013 |
| ISO 10993-5:2009 | InternationalOrganization ofStandardization | Biological Evaluation of MedicalDevices - Part 5: Tests for In-Vitro Cytotoxicity | 2009 | 6/1/2009 |
| ISO 10993-10:2010 | InternationalOrganization ofStandardization | Biological Evaluation of MedicalDevices - Part 10: Tests for | 2010 | 8/1/2010 |
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| irritation and delayed-type ofhypersensitivity | ||||
|---|---|---|---|---|
| ASTM D5587-15 | American Societyfor Testing &Materials | Standard Test Method forTearing Strength of Fabrics byTrapezoid Procedure | 2019 | 7/1/2019 |
| ASTM D5034-09 | American Societyfor Testing &Materials | Standard Test Method forBreaking Strength andElongation of Textile Fabrics | 2017 | 7/15/2019 |
| ASTM C522 | American Societyfor Testing &Materials | Standard Test Method for AirflowResistance of AcousticalMaterials | 2016 | 4/1/2016 |
Summary of Clinical Testing
No clinical testing was performed.
Conclusion:
The conclusions drawn from the nonclinical testing demonstrate that the ProTEC-USA EZDoff Gown is as safe, as effective, and performs as well as or better than the legally marketed device predicate.
§ 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.