Who is the manufacturer of ProTEC-USA EZDoff Gown?

Cadillac Products, Inc. filed the 510(k) submission for ProTEC-USA EZDoff Gown (K210405).

What is the FDA product code for ProTEC-USA EZDoff Gown?

QPC. It is classified under 21 CFR 878.4040 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for ProTEC-USA EZDoff Gown?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like ProTEC-USA EZDoff Gown?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ProTEC-USA EZDoff Gown

Q: What are the predicate devices for ProTEC-USA EZDoff Gown?

ValueCare® Open Back Protective Gown (K160337).

K210405 · Cadillac Products, Inc. · QPC · Dec 15, 2021 · General, Plastic Surgery

Device Facts

Record ID	K210405
Device Name	ProTEC-USA EZDoff Gown
Applicant	Cadillac Products, Inc.
Product Code	QPC · General, Plastic Surgery
Decision Date	Dec 15, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4040
Device Class	Class 2

Intended 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 non-protective. The gown is not intended for use in the operating room.

Device Story

Single-use, non-sterile, disposable isolation gown; constructed from 41 gsm blue polyolefin (polyethylene) film; features open back, thumb loops, back perforation for removal, and waist ties. Used in healthcare settings by personnel to provide barrier protection against microorganisms, body fluids, and particulates. Not intended for operating room use. Provides Level 3 liquid barrier performance per AAMI PB70:2012. Device is donned by healthcare personnel; provides physical barrier to reduce cross-contamination risk.

Clinical Evidence

No clinical testing was performed. Evidence is based on bench testing, including flammability (16 CFR 1610), hydrostatic pressure (AATCC 127), water impact (AATCC 42), breaking strength (ASTM D5034), tearing strength (ASTM D5587), linting (ISO 9073-10), and air permeability (ASTM C522). Biocompatibility testing (cytotoxicity, sensitization, irritation) performed per ISO 10993 standards.

Technological Characteristics

Material: 41 gsm blue polyolefin (polyethylene) film. Design: Open back, thumb loops, waist ties, heat-sealed sleeves. Barrier: AAMI PB70:2012 Level 3. Flammability: 16 CFR 1610 Class 1. Biocompatibility: ISO 10993-1, -5, -10. Sterilization: Non-sterile.

Indications for Use

Indicated for health care patients and personnel to protect against transfer of microorganisms, body fluids, and particulate material. Not for use in operating rooms.

Regulatory Classification

Identification

Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.

Special Controls

*Classification.* (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible. (ii) Analysis and nonclinical testing must: (A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and (B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device. (iii) NIOSH approved under its regulation. (2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.

Predicate Devices

ValueCare® Open Back Protective Gown (K160337)

Related Devices

K233526 — Medline Open-back Level 3 Protective Gown · Medline Industries, LP · Mar 5, 2024
K212633 — Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue · String King Lacrosse, LLC · Nov 24, 2021
K223467 — Disposable Isolation Gown · Nanning Tecbod Biological Technology Co., Ltd. · Feb 10, 2023
K202310 — Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back · Wildcat Ppe, LLC · Jan 29, 2021
K160337 — Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns · Bam Corporation Limited · Jul 7, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/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 acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) | #### 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." {3}------------------------------------------------ ### 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. {4}------------------------------------------------ # 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 Back Protective Gown (K160337) | Proposed Device: ProTEC- USA EZDoff Gown (K210405) | Comparison | |---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------| | Intended Use / Indications for Use | These gowns are intendedto protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. The back of the gown is open and non- protective. They are not intended for use in the operating room. | 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. | Same | | Design | Design includes open back, thumb loops, back perforation for easy removal and waist tie | Design includes open back, thumb loops, back perforation for easy removal and waist tie | Same | | Material Composition | Made from extruded plastic film | Made from extruded plastic film (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 intendedto protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. The back of the gown is open and non- protective. They are not intended for use in the operating room. Non-Sterile | These gowns are intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. The back of the gown is open and non- protective. They are not intended for use in the operating room. Non-Sterile | Same | | | - Not Made with Natural Rubber Latex Meets ANSI/AAMI PB70: 2012 Level 3 Open Back Non- protective SingleUse, Disposable | - Not Made with Natural Rubber Latex Meets ANSI/AAMI PB70: 2012 Level 3 Open Back Non- protective Single Use, Disposable | | | Flammability 16 CFR 1610 | Meets Class 1 "normal flammability " in accordance to 16 CFR Part 1610 | Meets Class 1 "normal flammability " in accordance to 16 CFR Part 1610 | Same | | Liquid Barrier Performance Classification Properties | Device was tested in accordance with AAMI PB70:2012 and meets Level 3 requirements for an isolation gown. | Device was tested in accordance with AAMI PB70:2012 and meets Level 3 requirements for an isolation gown. | Same | | Biocompatibility | Pass ISO 10993-1 | Pass ISO 10993-1 | Same | | Tearing Strength / Resistance | Not Reported | 8N (Machine Direction) 22N (Transverse Direction) | Not reported for comparison | | Lint | Not Reported | Log10<4 | Not reported for comparison | | Air Permeability | Not Reported | 0 ft³/min/ft² | Not reported for comparison | | Tensile Strength | Not Reported | 52N (Machine Direction) 41N (Transverse Direction) | Not reported for comparison | | Sterilization Modality | None (Non-Sterile) | None (Non-Sterile) | Same | {5}------------------------------------------------ # Summary of Non-Clinical Testing Performed on the Proposed Device | Test Method | Purpose | Acceptance Criteria | Results | |----------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------| | Flammability | Test performed in accordance with (CPSC), 16 CFR Part 1610 | Average burn time ≥ 3.5s | Pass Meets Class 1 Flammability. | | Hydrostatic Pressure | Test performed in accordance with AAMI PB70:2012 utilizing three (3) nonconsecutive lots. | AATCC 127 ≥ 50 cm AQL of 4.0 | Pass Meets Level 3 liquid barrier requirements. | | Water Impact | Test performed in accordance with AAMI PB70:2012 utilizing three (3) nonconsecutive lots. | AATCC 42 ≤ 1.0g AQL of 4.0 | Pass Meets Level 3 liquid barrier requirements. | | Breaking strength | Test performed in accordance with ASTM D5034 utilizing three (3) nonconsecutive lots. | The standard does not include an acceptance criteria. | The test results reported values were 52N (Machine Direction), 41N (Transverse Direction). | | Tearing strength | Test performed in accordance with ASTM D5587 | The standard does not include an acceptance criteria. | The test results reported values were | {6}------------------------------------------------ | | utilizing three (3) nonconsecutive lots. | | 8N (Machine Direction), 22N (Transverse Direction). | |------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------|--------------------------------------------------------------| | Linting | Test performed in accordance with ISO 9073-10 utilizing three (3) nonconsecutive lots. | The standard does not include an acceptance criteria. | The test results reported value was $Log_{10}<4$ . | | Air Permeability | Test performed in accordance with ASTM C522. | The standard does not include an acceptance criteria. | The test results reported value was 0 ft3/min/ft2 | # Biocompatibility Testing Performed on the Proposed Device | Test Method | Purpose | Acceptance Criteria | Results | |---------------|----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|---------| | Cytotoxicity | Test performed in accordance with ISO 10993- 5:2009. | Under the conditions of the studies ISO 10993- 5:2009, the proposed device is non- cytotoxic. | Pass | | Sensitization | Test performed in accordance with ISO 10993- 10:2010. | Under the conditions of the studies: ISO 10993- 10:2010, the proposed device is non- sensitizing | Pass | | Irritation | Test performed in accordance with ISO 10993- 10:2010. | Under the conditions of the studies: ISO 10993- 10:2010, the proposed device is non-irritating. | Pass | The EZDoff Gown was tested and conformed to the following standards and requirements: | Standard Number | Standards Organization | Standards Title | Version | Date | |------------------------------|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|---------|------------| | ASTM F2407 | American Society for Testing & Materials | Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities | 2013 | May 2013 | | AAMI PB70:2012 | American National Standard | Liquid Barrier Performance Classification of Protective Apparel and Drapes Intended for use in Health Care Facilities | 2012 | 6/21/2012 | | (CPSC), 16 CFR Part 1610 | Consumer Product Safety Commission | Standard for Flammability of Clothing Textiles | 2008 | 3/25/2008 | | ISO 10993- 1:2009/(R)2013 | International Organization of Standardization | Biological Evaluation of Medical Devices - Part 1: Evaluation and testing with a risk management process | 2013 | 10/15/2013 | | 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 | 2010 | 8/1/2010 | {7}------------------------------------------------ | | | irritation and delayed-type of hypersensitivity | | | |---------------|------------------------------------------------|------------------------------------------------------------------------------------|------|-----------| | ASTM D5587-15 | American Society for Testing & Materials | Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure | 2019 | 7/1/2019 | | ASTM D5034-09 | American Society for Testing & Materials | Standard Test Method for Breaking Strength and Elongation of Textile Fabrics | 2017 | 7/15/2019 | | ASTM C522 | American Society for Testing & Materials | Standard Test Method for Airflow Resistance of Acoustical Materials | 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.