Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device is a surgical gown, a physical barrier product, and the summary describes standard material and performance testing, with no mention of AI or ML.

Therapeutic

No
The device is a surgical gown, intended to protect personnel and patients from microorganisms and fluids, not to treat a disease or condition.

Diagnostic

No

Explanation: The device is a surgical gown, which is personal protective equipment designed to protect users and patients from the transfer of microorganisms and fluids during medical procedures. It does not perform any diagnostic function.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a surgical gown, which is a physical, disposable medical device made of 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 is to protect operating room personnel and patients from the transfer of microorganisms, body fluids, and particulate material during surgical procedures. This is a barrier function, not a diagnostic one.
Device Description: The description focuses on the physical characteristics of the gown (single use, disposable, sterile, sizes, barrier level) and its purpose as a protective barrier.
Lack of Diagnostic Elements: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to diagnose a condition, monitor a disease, or screen for a health issue.
Performance Studies: The performance studies listed are related to the physical properties and safety of the gown as a barrier (flammability, strength, permeability, biocompatibility), not diagnostic accuracy or performance.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. This surgical gown does not fit that definition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gown met the requirements for Level 3 classification.

Product codes (comma separated list FDA assigned to the subject device)

FYA

Device Description

The proposed device is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The proposed device is single use, disposable medical devices and are provided in sterile. The surgical gown is available in six product sizes, including S, M, L, XL, XXL and XXXL. The barrier protection level for surgical gown met AAMI Level 3.

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

operating room personnel / during surgical procedure

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 demonstrated that the proposed device complies with the following standards:

16 CFR Part 1610 Standard for the Flammability of Clothing Textiles
AATCC 127: 2017 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)
ASTM D737: 2018 Standard Test Method for Air Permeability of Textile Fabrics
ASTM F88/F88M: 2015 Standard Test Method for Seal Strength of Flexible Barrier Materials
ASTM F1929: 2015 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
ISO 10993-7: 2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals
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

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

Flammability: Class 1 Pass
Hydrostatic pressure: Average 72.05 cm (>50 cm acceptance criteria)
Water impact: Average 0.45g (≤1.0 g acceptance criteria)
Breaking strength: MD: Average 74.88, CD: Average 50.73 (>20N acceptance criteria)
Tearing strength: MD: Average 63.87, CD: Average 34.91 (>20N acceptance criteria)
Linting: Average 3.4 (Log10(particle count) 30 ft³/min/ft² acceptance criteria)
EO/ECH Residue: EO: Average 0.95 mg/device (

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

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October 18, 2021

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

Re: K211809

Trade/Device Name: Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: September 6, 2021 Received: September 14, 2021

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

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K211809

Device Name Surgical Gown

Indications for Use (Describe)

Surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gown met the requirements for Level 3 classification.

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

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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: K211809

1. Date of Preparation: 09/08/2021
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: lynn.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

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4. Identification of Proposed Device

Trade Name: Surgical Gown Common Name: Surgical Gown

Regulatory Information

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

Indication for use:

Surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gown met the requirements for Level 3 classification.

Device Description:

The proposed device is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. The proposed device is single use, disposable medical devices and are provided in sterile. The surgical gown is available in six product sizes, including S, M, L, XL, XXL and XXXL. The barrier protection level for surgical gown met AAMI Level 3.

ર : Identification of Predicate Device
510(k) Number: K172987; GMAX Industries, Inc. Product Name: Surgical Gown (AE1001, AE2001, AE3001)
Technological Characteristics Comparison With The Predicate Device 6.

Table 1. General Comparison

Item	Proposed Device	Predicate Device K172987	Comparison

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Product Code	FYA	FYA	Same
Regulation No.	21CFR 878.4040	21CFR 878.4040	Same
Class	II	II	Same
Indications for Use	Surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the surgical gown met the requirements for Level 3 classification. | Surgical gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

Different - Indications for Use

The proposed device and predicate device are intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Per ANSI/AAMI PB70:2012, the proposed device met the requirements for Level 3 classification, while the predicate device met the requirements for Level 2 and Level 3 classification. The indications for use for the proposed device can be covered by the predicate device.

Similar – Style

The style for the proposed device is different from the predicate device. The proposed device is a nonreinforced device, while the predicate device is available in three types, non-reinforced, fabric

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reinforced and poly-reinforced. The style for the proposed device can be covered by the predicate device.

Item	Proposed Device	Predicate Device K172987	Comparison
Weight per square (g)	43g/m2	44g/m2	Different
Size	S, M, L, XL, XXL, XXXL	XL	Different
Flammability	Class I	Class I	Same
Hydrostatic pressure	>50 cm	AE series: >20 cm;
AG series: >50 cm	Same
Water impact	≤1.0 g	≤1.0 g	Same
Breaking strength	>20N	≥20N	Same
Tearing strength	>20N	>30N	Different
Linting	Log10≤4	Log1030 ft³/min/ft²	>30 ft³/min/ft²
Barrier protection level	Level 3 per AAMI PB 70	Level 2/Level 3 per AAMI PB 70	Similar
Material	SMS, Polyester, Nylon	SMMMS, Polypropylene, PE(Poly Ethylene), Polyester	Different
Biocompatibility
Cytotoxicity
Irritation
Sensitization	Under the conditions of the study, the device is non-toxic, non-irritating, and non-sensitizing.	Under the conditions of the study, the device is non-toxic, non-irritating, and non-sensitizing.	Same
Sterilization	Sterile
Method: Ethylene Oxide (EO);
Sterilization Assurance Level
(SAL): 10-6	Non-sterile	Different

Table 2.Technological Comparison

Different - Weight per square

The weight per square for the proposed device is different from the predicate device.

Different - Size

The size for the proposed device is different from the predicate device. The proposed device is available in 6 product sizes, including S, M, L, XL, XXL and XXXL.

Different - Tearing strength

The tearing strength for the proposed device is different from the predicate device,

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Similar - Barrier protection level

The barrier protection level for the proposed device is different from the predicate device.

Different - Material

The material for the proposed device is different from the predicate device.

Different - Sterilization

The product status of the proposed device is different from the predicate device. The proposed device is sterilized and the predicate device is non-sterilized.

7. Non-Clinical Test Conclusion

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 demonstrated that the proposed device complies with the following standards:

16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
AATCC 127: 2017 Water Resistance: Hydrostatic Pressure Test;
AATCC 42: 2017 Water Resistance: Impact Penetration Test;
A ISO 9073-10: 2003 Textiles-Test Methods for Nonwovens-Part 10: Lint and Other Particles Generation in the Dry State;
A 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);
A ASTM D737: 2018 Standard Test Method for Air Permeability of TextileFabrics;
A ASTM F88/F88M: 2015 Standard Test Method for Seal Strength of Flexible Barrier Materials;
ASTM F1929: 2015 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration;
ISO 10993-7: 2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals;
ISO 10993-5: 2009 Biological Evaluation of Medical Devices-Part 5: Tests for in Vitro Cytotoxicity;
A ISO 10993-10: 2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization;

	Table 3. Performance Testing
--	------------------------------	--

Test Method	Purpose	Acceptance Criteria

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
requirements	Class 1
Pass
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	Average 72.05 cm
Water impact	The test was performed in accordance
with AATCC 42: 2017 Water
Resistance: Impact Penetration Test to
evaluate the water impact of the test
sample.	≤1.0 g	Average 0.45g
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.	>20N	MD: Average 74.88
CD: Average 50.73
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.	>20N	MD: Average 63.87
CD: Average 34.91
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.	$Log_{10}(particle count) 30 ft³/min/ft²	Average 35.3
EO/ECH
Residue	The test was performed in accordance
with ISO 10993-7:2008 Biological
evaluation of medical devices - Part 7:
Ethylene oxide sterilization residuals to
evaluate the level of sterilant residues.	EO: