Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a protective gown and the description focuses on material properties and barrier performance, with no mention of AI/ML.

Therapeutic

No.
The device description and intended use clearly state that the gowns are for protection against microorganisms and body fluids, not for treating or curing a medical condition.

Diagnostic

No

Explanation: The device described is a protective gown, which is designed to protect healthcare personnel and patients from the transfer of microorganisms and fluids. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device description clearly indicates it is a physical protective gown made of laminate material, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the gowns are for protecting healthcare personnel and patients from the transfer of microorganisms, body fluids, and particulate material. This is a barrier protection function, not a diagnostic one.
Device Description: The description focuses on the physical characteristics and materials of the gown, designed for protection.
Lack of Diagnostic Elements: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) or providing information about a person's health status, which are key characteristics of IVDs.
Performance Studies: The performance studies focus on barrier properties, material strength, and biocompatibility, not on diagnostic accuracy or performance.

IVDs are devices used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This protective gown does not perform any such function.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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/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 provided non-sterile.

Product codes

OPC,QPC

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

health care personnel

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical 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

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).

Summary for Non-Clinical Testing:
Blood-Borne Pathogens penetration: Test results Pass. Meets requirement.
Hydrostatic pressure: Test results >130 cm H2O. Meets requirement.
Basis weight: Test results 50±6 gsm. Meets requirement.
Tensile strength: Test results Machine Direction (MD) ≥ 30 N, Cross Direction (CD) ≥ 30 N. Meets requirement.
Tear strength: Test results Machine Direction (MD) ≥ 10 N, Cross Direction (CD) ≥ 10 N. Meets requirement.
Seam Strength: Test results ≥30N. Meets requirement.
Lint generation: Test results Size of particles counted: 3mcg 25mcg. Meets requirement.
Flammability: Test results Class I. Meets requirement.
Biocompatibility: Test results:
-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.
All meet requirements.

Summary for Clinical Testing: Not Applicable

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K182830

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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)
Prescription Use (Part 21 CFR 801 Subpart D)	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

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

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.