Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a physical isolation gown and the summary describes its material properties and barrier performance, with no mention of software, algorithms, or data processing.

Therapeutic

No
The device is a protective garment (gown) intended to prevent the transfer of microorganisms and body fluids, not to treat or cure a disease or condition.

Diagnostic

No

Explanation: The device, a Surgical Isolation Cover Gown, is described as intended to protect healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. Its function is to provide barrier protection, not to diagnose or detect medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "single use, disposable medical device" and describes physical characteristics like size, color, and barrier protection level, indicating it is a physical product, not software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Description: The provided description clearly states the device is a "Surgical Isolation Cover Gown" intended to protect healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. It is a physical barrier worn on the body.
Intended Use: The intended use is for personal protection, not for analyzing biological samples.
Lack of IVD Characteristics: The description does not mention any testing of biological samples, analysis of biomarkers, or any other activity associated with in vitro diagnostics.

The information provided describes a Class II medical device (based on the AAMI Level 3 barrier protection and intended use) that serves as a protective barrier, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Surgical Isolation Cover Gown is intended to protect health care persomel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Surgical Isolation Cover Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/A AMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Surgical Isolation Cover Gown is a single use, disposable medical device provided non-sterile.

Product codes

FYC

Device Description

The proposed device is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. The proposed device is a single use, disposable medical device provided non-sterile.

The proposed device is available in nine sizes, including XS, S, M, L, XL, 2XL, 3XL, 4XL, 5XL. The barrier protection level for Surgical Isolation Cover Gown meets AAMI Level 3. The proposed device is provided in yellow.

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 persomel

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 tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate device. The test results demonstrate that the proposed device complies with the following standards:

16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
AATCC 127: 2018 Water Resistance: Hydrostatic Pressure Test;
AATCC 42: 2017 Water Resistance: Impact Penetration Test;
ISO 9073-10: 2003 Textiles-Test Methods for Nonwovens-Part 10: Lint and Other Particles Generation in the Dry State;
ASTM D1683/D1683M: 2017(2018) Standard Test Method for Failure in Sewn Seams of Woven Fabrics;
ASTM D5587: 2015(2019) Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure:
ASTM D5034: 2009(2017) 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;
ASTM D737-18: 2018 Standard Test Method for Air Permeability of Textile Fabrics

Key results included:

Flammability: Class 1
Hydrostatic Pressure: Mean = 70.63 cm H2O, Max = 72.33 cm H2O, Min = 68.88 cm H2O
Water Impact: Mean = 0.58 g, Max = 0.69 g, Min = 0.49 g
Breaking Strength: MD: Mean = 74.82 N, Max = 79.64 N, Min = 70.43 N; CD: Mean = 49.35 N, Max = 55.18 N, Min = 40.96 N
Tearing Strength: MD: Mean = 62.92 N, Max = 69.72 N, Min = 62.01 N; CD: Mean = 32.57 N, Max = 34.99 N, Min = 30.05 N
Linting: Side A: Log10(lint count): Mean 3.4; Side B: Log10(lint count): Mean 3.4
Seam Strength: Mean = 102.92 N, Max = 109.98 N, Min = 95.37 N
Air Permeability: Mean 35.4 ft³/min/ft²
Cytotoxicity: Non-cytotoxic
Sensitization: Non-sensitizing
Irritation: Non-irritating

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

Flammability: Class 1
Hydrostatic Pressure: Mean = 70.63 cm H2O, Max = 72.33 cm H2O, Min = 68.88 cm H2O. Acceptance Criteria: >50 cm H2O
Water Impact: Mean = 0.58 g, Max = 0.69 g, Min = 0.49 g. Acceptance Criteria: 20 N
Tearing Strength: MD: Mean = 62.92 N, Max = 69.72 N, Min = 62.01 N; CD: Mean = 32.57 N, Max = 34.99 N, Min = 30.05 N. Acceptance Criteria: >20 N
Linting: Side A: Log10(lint count): Mean 3.4; Side B: Log10(lint count): Mean 3.4. Acceptance Criteria: Log10(particle count) 50 N
Air Permeability: Mean 35.4 ft³/min/ft². Acceptance Criteria: >30 ft³/min/ft²
Cytotoxicity: The viability was >= 70% of the blank. And the 50% extract of the test sample had a higher viability than the 100% extract. Under the conditions of the study, the proposed device was non-cytotoxic. Acceptance Criteria: The viability should be >= 70% of the blank. And the 50% extract of the test sample should have at least the same or a higher viability than the 100% extract.
Sensitization: Under the conditions of the study, the proposed device was non-sensitizing. Acceptance Criteria: Non-sensitizing
Irritation: Under the conditions of the study, the proposed device was non-irritating. Acceptance Criteria: Non-irritating

Predicate Device(s)

K171535

Reference Device(s)

K171535

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). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

June 10, 2022

Wuhan Dymex Healthcare Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co.,Ltd P.O.box 120-119 Shanghai. 200120 China

Re: K220528

Trade/Device Name: Surgical Isolation Cover Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYC Dated: May 5, 2022 Received: May 9, 2022

Dear Diana Hong:

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-reporting-

combination-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,

Bifeng Qian, M.D., Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K220528

Device Name Surgical Isolation Cover Gown

Indications for Use (Describe)

The Surgical Isolation Cover Gown is intended to protect health care persomel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Surgical Isolation Cover Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/A AMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Surgical Isolation Cover Gown is a single use, disposable medical device provided non-sterile.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K220528

1. Date of Preparation: 05/05/2022
1. Sponsor Identification

Wuhan Dymex Healthcare Co., Ltd. Room 1701, Unit 2, Building 5, Jinsegangwan Phase 5, Dongfeng Avenue, Wuhan, 430000, China. Establishment Registration Number: 3013006775

Contact Person: Lynn Wu Position: Sales Manager Tel: +86-27-85827780 Fax: +86-27-85827780 Email: 1ynn.w@medlinkindustry.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Jinlei Tang (Alternative Contact Person)

Mid-Link Consulting Co., Ltd.

P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net

1. Identification of Proposed Device
  Trade Name: Surgical Isolation Cover Gown Common Name: Isolation Gown

Regulatory Information

4

Classification Name: Surgical Isolation Gown Classification: II; Product Code: FYC; Regulation Number: 21 CFR 878.4040 Review Panel: General Hospital;

Indications for Use:

The Surgical Isolation Cover Gown is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. In addition, the Surgical Isolation Cover Gown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). The Surgical Isolation Cover Gown is a single use, disposable medical device provided non-sterile.

Device Description:

The proposed device is intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. Not intended for use in the operating room. The proposed device is a single use, disposable medical device provided non-sterile.

The proposed device is available in nine sizes, including XS, S, M, L, XL, 2XL, 3XL, 4XL, 5XL. The barrier protection level for Surgical Isolation Cover Gown meets AAMI Level 3. The proposed device is provided in yellow.

5. Identification of Predicate Device

510(k) Number: K171535 Product Name: Surgical Isolation Gown

5

6. Summary of Technological characteristics

Item	Proposed Device	Predicate Device K171535	Remark
Product Code	FYC	FYC	Same
Regulation No.	21CFR 878.4040	21CFR 878.4040	Same
Class	II	II	Same
Indications for Use	The Surgical Isolation Cover
Gown is intended to protect health
care patients and health care
personnel from the transfer of
microorganisms, body fluids and
particulate material. Not intended
for use in the operating room. In
addition, the Surgical Isolation
Cover Gown meets the
requirements of an AAMI Level 3
barrier protection for an isolation
gown per ANSI/AAMI PB70:2012
Liquid Barrier Performance and
Classification of Protective
Apparel Drapes Intended for Use
in Health Care Facilities
(ANSI/AAMI PB70). The Surgical
Isolation Cover Gown is a single
use, disposable medical device
provided non-sterile.	The Surgical Isolation Gown is
intended to protect health care
patients and health care personnel
from the transfer of
microorganisms, body fluids and
particulate material. Not intended
for use in the operating room. In
addition, the Surgical Isolation
Gown meets the requirements of
an AAMI Level 3 barrier
protection for an isolation gown
per ANSI/AAMI PB70:2012
Liquid Barrier Performance and
Classification of Protective
Apparel Drapes Intended for Use
in Health Care Facilities
(ANSI/AAMI PB70). The Surgical
Isolation Gown is a single use,
disposable medical device
provided non-sterile.	Same
Design	Neck Closure
Yellow Belt Tie
Elastic Cuffs	Medical Tape Neck Closure
White Belt Tie
Snap fastener	Similar
Use	Single Use, Disposable	Single Use, Disposable	Same
Color	Yellow	Yellow	Same
Labeling	Conform with 21CFR Part 801	Conform with 21CFR Part 801	Same

Table 1 General Comparison

Table 2 Safety and Effectiveness Comparison
---------------------------------------------	--

Item	Proposed Device	Reference Device K171535	Remark
Weight per square	35 g/m²	Testing not performed	Different
Size	XS, S, M, L,
XL,2XL,3XL,4XL,5XL	U, XL, 2XL	Different
Flammability	Class I	Class I	Same

6

| Hydrostatic
Pressure (cm H2O) | | Mean = 70.63
Max = 72.33
Min = 68.88 | CHEST/BACK/SLEEVE:
Mean = 69
Ind Min = 54
Ind Max = 84 | Different |
|----------------------------------|----|----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Water impact (g) | | Mean = 0.58
Max = 0.69
Min = 0.49 | Sleeve Seams:
Mean = 0.04
Ind Min = 0.02
Ind Max = 0.08
CHEST:
Mean = 0.04
Ind Min = 0.02
Ind Max = 0.05
Back:
Mean = 0.05
Ind Min = 0.04
Ind Max = 0.07 | Different |
| Breaking
strength | MD | Mean = 74.82 N
Max = 79.64 N
Min = 70.43 N | Mean = 20.71 lbs (92.16 N)
Ind Min = 19.73 lbs (87.80 N)
Ind Max = 21.87 lbs (97.32 N) | Different |
| Breaking
strength | CD | Mean = 49.35 N
Max = 55.18 N
Min = 40.96 N | Mean = 12.21 lbs (54.33 N)
Ind Min = 11.20 lbs (49.84 N)
Ind Max = 14.11 lbs (62.79 N) | Different |
| Tearing
strength | MD | Mean = 62.92 N
Max = 69.72 N
Min = 62.01 N | Mean = 3.48 lbs (15.49 N)
Ind Min = 2.82 lbs (12.55 N)
Ind Max = 3.93 lbs (17.49 N) | Different |
| Tearing
strength | CD | Mean = 32.57 N
Max = 34.99 N
Min = 30.05 N | Mean = 7.15 (31.82 N)
Ind Min = 6.20 (27.59 N)
Ind Max = 7.70 (34.27 N) | Different |
| Linting | | Side A:
Log10(lint count): Mean 3.4
Side B:
Log10(lint count): Mean 3.4 | SIDE A: OUTSIDE
TOTAL >0.3 1024
TOTAL >0.5 658
SIDE B: INSIDE
TOTAL >0.3 1066
TOTAL >0.5 697 | Different |
| Seam strength | | Mean = 102.92 N
Max = 109.98 N
Min = 95.37 N | / | Different |
| Air permeability | | Mean 35.4 ft³/min/ft² | / | Different |
| Barrier protection
level | | Level 3 per AAMI PB 70 | Level 3 per AAMI PB 70 | Same |

7

Material	SMS Nonwoven Fabric	Polypropylene SMS non woven	Same
Biocompatibility
Cytotoxicity
Irritation
Sensitization	The test was done against ISO10993-5 and ISO10993-10.
The result indicates the gown is noncytotoxic, non-irritating, and non-sensitizing per ISO 10993-1.	The test was done against ISO10993-5 and ISO10993-10.
The result indicates the gown is noncytotoxic, non-irritating, and non-sensitizing per ISO 10993-1.	Same
Sterilization	Non-sterile	Non-sterile	Same

Similar - Design

The design of the proposed device is not exactly the same as the predicate device. The belt tie of the proposed device is yellow, while the belt tie of the predicate device is white. However, the belt tie is used to close the back of the gown. The difference in the color of belt tie will not affect the device performance.

Different - Weight per square

No information was available on the Weight per square of the predicate device. The weight per square for the proposed device is 35g/m², which is similar to the most products on the market. And the difference in the weight per square will not affect the intended use. In addition, the performance testing was conducted on the proposed device and the results demonstrate that the proposed device can meet the barrier protection level 3 requirement as required by PB70.

Different - Size

The size for the proposed device is different from the predicate device. The proposed device is available in nine size, including XS, S, M, L, XL,2XL,3XL,4XL,5XL, while the predicate device is available in three size, U, XL and 2XL. However, the difference in the size will not affect the device performance. Different sizes can be selected by surgeon's condition.

Different - Hydrostatic pressure

The hydrostatic pressure for the proposed device is different from the predicate device. the higher the hydrostatic pressure value, the higher the protection of the isolation gown. The hydrostatic pressure of the proposed device is 70.63 cm H2O, which is greater than the 69 cm H2O of the predicate device.

Different - Water impact

The water impact for the proposed device is different from the predicate device. However, the water in impact test was conducted on the proposed device and the results demonstrate that the proposed device meets the barrier protection level 3 requirement, i.e., no more than 1.0g, as required by PB70.

Different - Breaking strength

8

The breaking strength for the proposed device is different from the predicate device. Although the MD and CD breaking strength of the proposed device is smaller than the predicate device, the MD and CD breaking strength of the proposed device meets ASTM F2407-20's requirement of greater than 30N.

Different - Tearing strength

The tearing strength for the proposed device is different from the predicate device. Tearing strength is one of the indicators to evaluate the ability of the isolation gown to withstand destructive force. The greater the tearing strength value, the stronger the ability to withstand destructive force. The tearing strength of the proposed device is larger than the predicate device.

Different - Linting

The linting for the proposed device is different from the predicate device. However, the linting test was conducted on the proposed device and the testing results demonstrate that the proposed device can meet the requirements of log10 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;

A AATCC 127: 2018 Water Resistance: Hydrostatic Pressure Test;
AATCC 42: 2017 Water Resistance: Impact Penetration Test;
ISO 9073-10: 2003 Textiles-Test Methods for Nonwovens-Part 10: Lint and Other Particles Generation in the Dry State;
ASTM D1683/D1683M: 2017(2018) Standard Test Method for Failure in Sewn Seams of Woven Fabrics;
ASTM D5587: 2015(2019) Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure:
ASTM D5034: 2009(2017) Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test);

9

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;
ASTM D737-18: 2018 Standard Test Method for Air Permeability of Textile Fabrics

| Test
Methodology | Purpose | Acceptance
Criteria | Result |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|--------------------------------------------------------------------------------------------------------------------|
| Flammability | The test was performed in accordance
with 16 CFR Part 1610 Standard for
the Flammability of Clothing Textiles
to evaluate the flammability of the
test sample. | Meets Class 1
requirements | Class 1 |
| Hydrostatic
pressure | The test was performed in accordance
with AATCC 127: 2017 Water
Resistance: Hydrostatic Pressure Test
to determine the hydrostatic pressure
of the test sample. | >50 cm H2O | Mean = 70.63 cm H2O
Max = 72.33 cm H2O
Min = 68.88 cm H2O |
| Water impact | The test was performed in accordance
with AATCC 127: 2017 Water
Resistance: Hydrostatic Pressure Test
to determine the hydrostatic pressure
of the test sample. | ≤1.0 g | Mean = 0.58 g
Max = 0.69 g
Min = 0.49 g |
| Breaking
strength | The test was performed in accordance
with ASTM D 5034:2009(2017)
Standard Test Method for Breaking
Strength and Elongation of Textile
Fabrics (Grab Test) to evaluate the
breaking strength of the test sample. | >20 N | MD:
Mean = 74.82 N
Max = 79.64 N
Min = 70.43 N
CD:
Mean = 49.35 N
Max = 55.18 N
Min = 40.96 N |
| Tearing
strength | The test was performed in accordance
with
ASTM
D5587:2015(2019)
Standard Test Method for Tearing
Strength of Fabrics by Trapezoid
Procedure to evaluate the tearing
strength of the test sample. | >20 N | MD:
Mean = 62.92 N
Max = 69.72 N
Min = 62.01 N
CD:
Mean = 32.57 N
Max = 34.99 N
Min = 30.05 N |

Table 3 Summary of Performance Testing

10

| Linting | The test was performed in accordance
with ISO 9073-10:2003 Textiles-Test
Methods for Nonwovens-Pat 10: Lint
and Other Particles Generation in the
Dry State to evaluate the linting of
the test sample. | Log10(particle
count) 50 N | Mean = 102.92 N
Max = 109.98 N
Min = 95.37 N |
| | | | |
| | | | |
| | | | |
| | | | |
| Air
permeability | The test was performed in accordance
with ASTM D737: 2018 Standard
Test Method for Air Permeability of
Textile Fabrics to evaluate the air
permeability of the test sample. | >30 ft³/min/ft² | Mean 35.4 ft³/min/ft² |
| | | | |
| | | | |
| | | | |
| | | | |

Table 4 Summary of Biocompatibility Testing

Test Methodology	Purpose	Acceptance Criteria
Cytotoxicity	The test was performed
in accordance with ISO
10993-5 Third edition
2009-06-01 Biological
evaluation of medical
devices - Part 5: Tests
for in vitro cytotoxicity
to evaluate the
cytotoxicity of the test
sample.	The viability should be
$\ge$ 70% of the blank.
And the 50% extract of
the test sample should
have at least the same or
a higher viability than
the 100% extract.	The viability was $\ge$ 70%
of the blank. And the
50% extract of the test
sample had a higher
viability than the 100%
extract. Under the
conditions of the study,
the proposed device
was non-cytotoxic.
Sensitization	The test was performed
in accordance with ISO
10993-10 Third Edition
2010-08-01 Biological
evaluation of medical
devices - Part 10: Tests
for irritation and skin
sensitization to evaluate
the sensitization of the
test sample.	Non-sensitizing	Under the conditions of
the study, the proposed
device was
non-sensitizing.

11

| Irritation | The test was performed
in accordance with ISO
10993-10 Third Edition
2010-08-01 Biological
evaluation of medical
devices - Part 10: Tests
for irritation and skin
sensitization to evaluate
the irritation of the test
sample | Non-irritating | Under the conditions of
the study, the proposed
device
was
non-irritating. |

------------	----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	----------------	----------------------------------------------------------------------------------------

Clinical Test Conclusion 8.

No clinical study is included in this submission.

9. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the proposed devices are as safe, as effective, and perform as well as or better than the legally marketed predicate device K171535.