Who is the manufacturer of Dukal Corporation AAMI Level 4 Open-Back Protective Gown?

Dukal Corporation filed the 510(k) submission for Dukal Corporation AAMI Level 4 Open-Back Protective Gown (K212464).

What is the FDA product code for Dukal Corporation AAMI Level 4 Open-Back Protective 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 Dukal Corporation AAMI Level 4 Open-Back Protective Gown?

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

What are the predicate devices for Dukal Corporation AAMI Level 4 Open-Back Protective Gown?

Cardinal Health Poly-Coated Open-Back Protective Gowns (level 4) (K182830).

Who can help prepare an FDA 510(k) submission like Dukal Corporation AAMI Level 4 Open-Back Protective 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.

Dukal Corporation AAMI Level 4 Open-Back Protective Gown

K212464 · Dukal Corporation · QPC · Mar 30, 2022 · General, Plastic Surgery

Device Facts

Record ID	K212464
Device Name	Dukal Corporation AAMI Level 4 Open-Back Protective Gown
Applicant	Dukal Corporation
Product Code	QPC · General, Plastic Surgery
Decision Date	Mar 30, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4040
Device Class	Class 2

Intended Use

The Dukal AAMI Level 4 Open-Back Protective Gowns are intended to protect health care personnel and patients from the transfer of microorganisms, body fluids, and particulate material. These gowns are not intended for use in the operating room. The Dukal AAMI Level 4 Open-Back Protective Gown meets the barrier protection requirements of AAMI Level 4 per ANSI/A AMI PB70, 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. These gowns are single use, disposable medical devices provided non-sterile.

Device Story

Protective gown designed to shield healthcare personnel and patients from microorganisms, body fluids, and particulates. Constructed from SMS nonwoven laminate with polyethylene film. Features include open-back design (non-protective), neck removal, belt ties, and thumb-hook cuff sleeves. Available in Regular and X-Large sizes. Intended for non-OR clinical environments. Single-use, disposable, non-sterile. Provides AAMI Level 4 barrier protection in critical zones (body/sleeves/seams).

Clinical Evidence

No clinical data. Bench testing only. Conformance demonstrated via ASTM F1671 (viral barrier), AATCC 127 (hydrostatic pressure), ASTM D5034 (tensile strength), ASTM D5587 (tear strength), ASTM D1683 (seam strength), ISO 9073-10 (lint generation), 16 CFR 1610 (flammability), and ISO 10993 (biocompatibility).

Technological Characteristics

Materials: SMS nonwoven with polyethylene film. Barrier: AAMI Level 4 per ANSI/AAMI PB70:2012. Standards: ASTM D3776 (basis weight), ASTM D5034 (tensile), ASTM D5587 (tear), ASTM D1683 (seam), ISO 9073-10 (lint), 16 CFR 1610 (flammability), ISO 10993-5/10 (biocompatibility). Design: Open-back, thumb-hook cuffs, belt ties. Sterilization: Non-sterile.

Indications for Use

Indicated for health care personnel and patients to protect against transfer of microorganisms, body fluids, and particulate material. Not for use in the operating room. Single-use, disposable, non-sterile.

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

Cardinal Health Poly-Coated Open-Back Protective Gowns (level 4) (K182830)

Related Devices

K182830 — Cardinal HealthTM Poly-Coated Open-Back Protective Gown · Cardinal Health200, LLC · Apr 26, 2019
K222128 — Protective Gown AAMI Level 4 · Kenpax International Limited · Aug 8, 2023
K212422 — Disposable Surgical Isolation Gown · Crown Name Disposable Hygiene Products Fty., Ltd. · Apr 29, 2022
K163191 — ComfortGuard Surgical Gown, i600, Film Reinforced · Gri Medical & Electrical Technology Co., Ltd. · Feb 27, 2017
K242689 — AAMI Level 4 Protective; Gown · Azac Group · Jan 13, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. March 30, 2022 Dukal, LLC Megan Quevedo Quality and Regulatory Affairs Supervisor 2 Fleetwood Court Ronkonkoma, New York 11779 Re: K212464 Trade/Device Name: Dukal AAMI Level 4 Open-Back Protective Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: OPC Dated: March 2, 2022 Received: March 2, 2022 Dear Megan Quevedo: 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 mediation-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 510(k) Number (if known) K212464 Device Name Dukal AAMI Level 4 Open-Back Protective Gown Indications for Use (Describe) The Dukal AAMI Level 4 Open-Back Protective Gowns are intended to protect health care personnel and patients from the transfer of microorganisms, body fluids, and particulate material. These gowns are not intended for use in the operating room. The Dukal AAMI Level 4 Open-Back Protective Gown meets the barrier protection requirements of AAMI Level 4 per ANSI/A AMI PB70, 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. These gowns are single use, disposable medical devices provided non-sterile. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------| | <label><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | #### 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}------------------------------------------------ # 510(k) K212464 SUMMARY ### 510(k) Premarket Notification for Dukal AAMI Level 4 Open-Back Protective Gown | 1. | Submitter: | Dukal, LLC 2 Fleetwood Court Ronkonkoma NY 11779 Phone: 631-656-3800 Fax: 631-656-3810 | |--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 2. | FDA Registration Number: | 2435946 | | 3. | Regulatory Affairs Contact: | Megan Quevedo Quality and Regulatory Affairs Supervisor 2 Fleetwood Court Ronkonkoma NY 11779 Telephone Number: 631-656-3800 ext. 133 Fax Number: 631-656-3810 | | 4. | Date Summary Prepared: | March 29, 2022 | | 5. | Name of Device: | Dukal AAMI Level 4 Open-Back Protective Gown | | 6. | Trade Name: | Dukal AAMI Level 4 Open-Back Protective Gown | | 7. | Common/Classification Name: | Gown, Non-Sterile, Non-Isolation, Intended to Provide Moderate or High Barrier Protection | | 8. | Regulation Number: | 21 CFR §878.4040 | | 9. | Device Class: | Class II | | 10. | Regulation Name: | Surgical Apparel | | 11. | Product Code: | QPC | | | 12. Predicate Device: | Cardinal Health Poly-Coated Open-Back Protective Gowns (level 4) • 510k #K182830, cleared on 4/26/2019 | | | 13. Device Description: | Dukal AAMI Level 4 Open-Back Protective Gowns are intended to protect health care personnel and patients from the transfer of microorganisms, body fluids, and particulate material These gowns are not intended - for | | | use in the operating room. The gowns are available on Regular and X-Large sizes. | | | | Dukal AAMI Level 4 Open-Back Protective Gowns are made with laminate material (SMS nonwoven material with polyethylene film). | | | | All gowns are blue, with neck removal feature, belt ties, and thumb hook cuff sleeves. | | | | These gowns are single use, disposable devices, that are provided non-sterile. | | | 14. Packaging: | 10 gowns/bag, 5 bags/case | | | 15. Indications for Use: | The Dukal AAMI Level 4 Open-Back Protective Gown are intended to protect health care personnel and patients from the transfer of microorganisms, body fluids, and particulate material. These gowns are not intended for use in the operating room. | | | | The Dukal AAMI Level 4 Open-Back Protective Gown meets the barrier protection requirements of AAMI Level 4 per ANSI/AAMI PB70, 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. | | | | These gowns are single, use, disposable medical devices | | {4}------------------------------------------------ # 16. Comparison of Technological Characteristics with the Predicate Device: | Element of Comparison | Predicate Device Cardinal Health (K182830) Poly-Coated Open-Back Gown | Subject Device Dukal Open-Back Protective Gown (K212464) | Comparison | |------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | 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 Dukal AAMI Level 4 Open-Back Protective Gowns are intended to protect health care personnel and patients from the transfer of microorganisms, body fluids, and particulate material. These gowns are | Same | | | Cardinal Health Poly-Coated | | | | | Open-Back Protective | not intended for use in | | | | Gown meets the barrier | the operating room. | | | | protection requirements of | | | | | AAMI Level 4 per ANSI/AAMI | The Dukal AAMI Level 4 | | | | PB70:2012, Liquid Barrier | Open-Back Protective | | | | Performance and Classification | Gown meets the barrier | | | | of Protective Apparel | protection requirements | | | | and Drapes Intended for Use in | of AAMI Level 4 per | | | | Health Care Facilities, but has | ANSI/AAMI PB70, Liquid | | | | an open back which | Barrier Performance and | | | | is non-protective. The Cardinal | Classification of Protective | | | | Health™ Poly-Coated Open- | Apparel and Drapes | | | | Back Protective Gown | Intended for Use in Health | | | | is a single use, disposable | Care Facilities, but has an | | | | medical device provided non- | open back which is non- | | | | sterile | protective. | | | | | These gowns are single, | | | | | use, disposable medical | | | | | devices provided non- | | | | | sterile. | | | Barrier Protection Level | 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 nonprotective. | 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 nonprotective. | Same | | Regulation, Classification, Product Code | Regulation Number: 21 CFR §878.4040 Device Class: Class II Regulation Name: Surgical Apparel Product Code: QPC | Regulation Number: 21 CFR §878.4040 Device Class: Class II Regulation Name: Surgical Apparel Product Code: QPC | Same | | Material Composition | Laminate (spunbond polypropylene coated with polyethylene) | Laminate (Spunbond + Meltblown + Spunbond (SMS) with polyethylene film) | Similar | | Product Color and Sizes | Blue Universal and XX-Large | Blue Regular and X-Large | Similar | | Design Features | Thumbhook cuff formed into sleeve or knit cuff sewn onto sleeve for keeping the sleeves in place on the wearer | Thumbhook cuff formed into sleeve for keeping the sleeves in place on the wearer | Similar | | | Belt Ties integrated into body Neck removal feature | Belt Ties integrated into body Neck removal feature | | | Sterility | Non-Sterile | Non-Sterile | Same | | Use | Single Use; Disposable | Single Use; Disposable | Same | | Biocompatibility | Under the conditions of each study, the Cardinal HealthTM Poly-Coated Open- Back Protective Gown is non- cytotoxic (ISO 10993-5), is non- irritating (ISO 10993-10), and is non-sensitizing (ISO 10993-10). | Under the conditions of each study, the Dukal AAMI Level 4 Open-Back Protective Gown is non- cytotoxic (ISO 10993-5), is non-irritating (ISO 10993- 10), is non-sensitizing (ISO 10993-10). | Same | {5}------------------------------------------------ {6}------------------------------------------------ # Comparison Summary of Non-Clinical Testing Results | Test | Test Results of Subject Device Dukal AAMI Level 4 Open-Back Protective Gown (meets ANSI/AAMI PB70:2012 Level 4 requirements) Note: Below results are for Sleeve and Body material | Test Results of Predicate Device Cardinal Health (K182830) Poly- Coated Open-Back Gown (meets ANSI/AAMI PB70:2012 Level 4 requirements) Finished Good Test Results: Mean (min/max) Note: Below results are for Sleeve and Body material | Comparison | |------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Basis Weight ASTM D3776/D3776M -20 | 50±6 gsm | 43.3 (39.9 / 46.1) gsm (according to previous revision ASTM D3776/D3776M-17) | Similar | | Tensile Strength ASTM D5034-21 | Machine Direction (MD) ≥ 30 N Cross Direction (CD) ≥ 30 N | 14.2 (12.6 / 16.1) lb (CD) (according to previous revision ASTM D5034-17) | Similar | | Tear Strength ASTM D5587-15 (2019) | Machine Direction (MD) ≥ 10 N Cross Direction (CD) ≥ 10 N | 6.0 (4.4 / 7.5) lb (MD) | Similar | | Seam Strength (ASTM D 1683) | ≥30N | ≥30N | Same | | Flammability CPSC, Part 1610 | Class 1 | Class 1 | Same | | Lint Generation (ISO 9073-10) | Size of particles counted: 3mcg- 25mcg | Size of particles counted: 3mcg- 25mcg | Same | | Hydrostatic Head AATCC 127:2018 | >130 cmH20 | >130 (130 / >130) cmH20 >51 (51 / >51) inH20 (According to previous revision AATCC 127:2017) | Same | | Viral barrier (resistance to bacteriophage Phi-X174) ASTM F1671-13 | Pass (For AAMI Level 4 Requirements): None Seen for Penetration of Phi-X174 Bacteriophage | Pass (For AAMI Level 4 Requirements): None Seen for Penetration of Phi-X174 Bacteriophage | Same | | Liquid Barrier Performance Classification Properties | All areas tested meet Level 4 performance requirements (ASTM F1671), which is the highest standardized level of barrier performance | All areas tested meet Level 4 performance requirements (ASTM F1671), which is the highest standardized level of barrier performance | Same | | | The Dukal AAMI Level 4 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). | 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). | | | Sterilization Modality | None, non-sterile | None, non-sterile | Same | | Biocompatibilit y-Cytotoxicity (ISO 10993-5), Irritation & Sensitization (ISO 10993-10) | • Under the conditions of the study, the device did not show cytotoxicity potential. • Under the conditions of the study, the irritation response | • Under the conditions of the study, the device did not show cytotoxicity potential. • Under the conditions of the study, the irritation response | Same | | category of the device was classified as Negligible. | category of the device was classified as Negligible. | | | | • Under the conditions of the study, the device showed no significant evidence of causing skin sensitization. | • Under the conditions of the study, the device showed no significant evidence of causing skin sensitization. | | | {7}------------------------------------------------ {8}------------------------------------------------ ### Non-Clinical Test Results: The subject protective gowns were tested and found conformance with the following standards: - 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles - AATCC 127: 2018 Water Resistance: Hydrostatic Pressure Test - ASTM F1671/F1671M-13 Standard Test Method for Resistance to Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage as a Test System - . ANSI AAMI PB70: 2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended For Use in Health Care Facilities - . ASTM D5587-15 (2019) Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure - ISO 9073-10:2003 Textiles-Test Methods for Nonwovens-Part 10: Lint and Other Particles Generation in the Dry State - ASTM D1683/D1683M-17:2017/(R)2018 Standard Test Method for Failure in Sewn Seams of Woven Fabrics - ASTM D3776/D3776M-20 Test Methods for Mass Per Unit Area (Weight) of Woven Fabric - . ASTM D5034-21 Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test) - ISO 10993-5:2009 Biological Evaluation of Medical Devices-Part 5: Tests for in Vitro Cytotoxicity - ISO 10993-10:2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization - ISO 10993-1:2018 Biological Evaluation of Medical Devices- Part 1: Evaluation and testing within ● a risk management process {9}------------------------------------------------ # Summary for Non-Clinical Testing: | Test Item | Test Standard Methods | Test Requirements | Test Results of Subject Device Dukal AAMI Level 4 Surgical Gown Note: Below results are for Sleeve and Body material | Remark | |-----------------------------------------|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------| | Blood-Borne Pathogens penetration | ASTM F1671 | Pass (For AAMI Level 4 Requirements): None Seen for Penetration of Phi-X174 Bacteriophage | Pass | Meets requirement | | Hydrostatic pressure | AATCC 127 | ≥100cm H2O (Individual) ≥140cm H2O (Average) | >130 cm H2O | Meets requirement | | Basis weight | ASTM D3776 | 50±6 gsm | 50±6 gsm | Meets requirement | | Tensile strength | ASTM D 5034 | Machine Direction (MD) ≥ 30 N Cross Direction (CD) ≥ 30 N | Machine Direction (MD) ≥ 30 N Cross Direction (CD) ≥ 30 N | Meets requirement | | Tear strength | ASTM D5587 | Machine Direction (MD) ≥ 10 N Cross Direction (CD) ≥ 10 N | Machine Direction (MD) ≥ 10 N Cross Direction (CD) ≥ 10 N | Meets requirement | | Seam Strength | ASTM D 1683 | ≥30N | ≥30N | Meets requirement | | Lint generation | ISO 9073-10 | Size of particles counted: 3mcg-25mcg | Size of particles counted: 3mcg 25mcg | Meets requirement | | Flammability | 16 CFR Part 1610 | Class I | Class I | Meets requirement | | Biocompatibility | ISO 10993-5 ISO 10993-10 | -Under the conditions of the study, the device does not show cytotoxicity potential. -Under the conditions of the study, the irritation response category of the device is classified as Negligible. -Under the conditions of the study, the device shows no significant evidence of causing skin sensitization. | -Under the conditions of the study, the device did not show cytotoxicity potential. -Under the conditions of the study, the irritation response category of the device was classified as Negligible. -Under the conditions of the study, the device showed no significant evidence of causing skin sensitization. | Meets requirement | {10}------------------------------------------------ ### Summary for Clinical Testing: Not Applicable Conclusions: The conclusion drawn from the nonclinical tests demonstrates that the subject devices in this 510(k) submission, Dukal AAMI Level 4 Open-Back Protective Gowns, are as safe, as effective, and perform as well as or better than the legally marketed predicate device cleared under K182830.