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 AE series surgical gowns met the requirements for Level 2 classification.

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

Device Description

The Surgical Gown is a single use, disposable medical device provided as bulk, non-sterile items to repackagers/ relabler for further packaging and Ethylene Oxide (EO) sterilization.

The subject device includes six models, which are provided in Table 1 Model List. The six models have the same product size, the only difference is whether the surgical gown has an inside reinforcement and material of the reinforcement. AG1001 and AE1001 don't have the reinforcement. AG2001 and AE2001 have an inside trapezoidal fabric-reinforcement on the chest and two sleeves of the gown. AG3001 and AE3001 have an inside rectangular poly-reinforcement on the chest and two sleeves of the gown.

AI/ML Overview

The document is a 510(k) summary for GMAX Industries, Inc.'s Surgical Gown (AE and AG series). It describes the device, its intended use, and demonstrates substantial equivalence to predicate devices based on non-clinical testing.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a comparison of the subject device (GMAX Surgical Gown) with two predicate devices (Medline Eclipse™ Surgical Gown and Disposable Surgical Gowns by Weihai Hongyu Nonwoven Fabric Products Co., Ltd.). The table highlights several physical and mechanical specifications as acceptance criteria and reports the subject device's performance against these criteria, or states "Not known" for predicate devices.

Item	Acceptance Criteria (Subject Device Performance)	Predicate Device 1 Performance	Predicate Device 2 Performance
Barrier Protection Level (AAMI PB70)	Level 2 (AE series) / Level 3 (AG series)	Level 2	Level 3
Tearing Strength	>30N	Not known	Not known
Fire Protection	Class I	Not known	Class I
Lint	$Log_{10} < 4$	Not known	Not known
Air Permeability	>30 ft3/min/ft2	Not known	Not known
Tensile Strength	≥20N	Not known	≥20N
Durability	Disposable	Disposable	Disposable
Biocompatibility	Non-toxic, non-irritating, non-sensitizing	Non-toxic, non-irritating, non-sensitizing	Non-toxic, non-irritating, non-sensitizing

Note on Acceptance Criteria: The document primarily uses the predicate devices' characteristics and recognized standards (like AAMI PB70) as benchmarks for "acceptance criteria." For some parameters, the subject device's specific performance values are presented as meeting these underlying standards or being "large enough for safety using" even when predicate values are unknown.

2. Sample Sizes and Data Provenance

The document explicitly states: "No clinical study is included in this submission."

Therefore, information regarding sample size for test sets, data provenance (e.g., country of origin, retrospective/prospective) for a clinical study is not applicable as no clinical study was conducted. The testing was non-clinical.

3. Number of Experts and Qualifications

This information is not applicable. Since no clinical study was performed and no human performance evaluation (e.g., diagnostic accuracy) was part of this submission, there was no need for experts to establish ground truth for a test set.

4. Adjudication Method

This information is not applicable for the same reasons as above.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable. No MRMC study was conducted. The submission is for a medical device (surgical gown) and focuses on physical and biological testing, not on comparative effectiveness for diagnosis or treatment involving human readers.

6. Standalone (Algorithm Only) Performance

This information is not applicable. The device is a surgical gown, not an algorithm or AI system.

7. Type of Ground Truth Used

For the non-clinical tests, the "ground truth" or reference standards used are established test methods from recognized standards organizations. These include:

AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes
ASTM D737-04 (2016) Standards Test Method for Air Permeability of Textile Fabrics
16 CFR 1610: 2008 Standard for the Flammability of Clothing Textiles
AATCC 127:2003 Water Resistance: Hydrostatic Pressure Test
AATCC 42:2007 Water Resistance: Impact Penetration Test
ISO 9073-10:2003 Textiles- Test Method for Nonwovens- Part 10: Lint and Other Particles Generation in the Dry State
ASTM D1683-11 Standard Test Method for Failure in Sewn Seams of Woven Apparel Fabrics
ASTM D5587-15 Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
ASTM D5034-09 (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

These standards define the methodologies and expected outcomes for each test.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical product (surgical gown), not a software or AI model that requires a "training set."

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the same reasons as above.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left is the Department of Health & Human Services logo, which features a stylized human figure. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

July 13, 2018

GMAX Industries, Inc. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O.Box 120-119 Shanghai, 200120 Cn

Re: K172987

Trade/Device Name: Surgical Gown (AE1001, AE2001, AE3001) Surgical Gown (AG1001, AG2001, AG3001) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: June 20, 2018 Received: June 22, 2018

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. 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Elizabeth F. Claverie -S

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172987

Device Name Surgical Gown (AE1001, AE2001, AE3001)

Indications for Use (Describe)

Per ANSVAAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the AE series surgical gowns met the requirements for Level 2 classification.

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."

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Indications for Use

510(k) Number (if known) K172987

Device Name Surgical Gown (AG1001, AG2001, AG3001)

Indications for Use (Describe)

Per ANSVAAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the AG series surgical gowns met the requirements for Level 3 classification.

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.

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."

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510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K172987

1. Date of Preparation: 7/12/2018
Sponsor Identification 2.

GMAX Industries, Inc.

2150 joshuas path, suite 205, Hauppauge, NY 11788

Contact Person: Julia Huang Position: Sales Manager Tel: 631-348-4050 ext 101 Fax: 630-348-4357 Email: Julia.huang@gmaxind.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)

Mid-Link Consulting Co., Ltd

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

Tel: +86-21-22815850, Fax: 3609253199 Email: info@mid-link.net

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4. Identification of Subject Device

Trade Name:

Surgical Gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001) Common Name: Gown, Surgical

Regulatory Information Classification Name: Gown, Surgical Classification: II Product Code: FYA Regulation Number: 21 CFR 878.4040 Review Panel: General& Plastic Surgery

Indications for Use for AE series:

Indications for Use for AG series:

Device Description

The Surgical Gown is a single use, disposable medical device provided as bulk, non-sterile items to repackagers/ relabler for further packaging and Ethylene Oxide (EO) sterilization.

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Table 1 Model List
Model	Size	Style	AAMI level
AG1001	XL	Non-reinforced	3
AG2001	XL	Fabric-reinforced	3
AG3001	XL	Poly-reinforced	3
AE1001	XL	Non-reinforced	2
AE2001	XL	Fabric-reinforced	2
AE3001	XL	Poly-reinforced	2

AE3001 have an inside rectangular poly-reinforcement on the chest and two sleeves of the gown.

న్. Identification of Predicate Devices
Predicate Device 1 510(k) Number: K043585 Product Name: Medline Eclipse™ Surgical Gown Manufacturer: MEDLINE INDUSTRIES, INC.

Predicate Device 2 510(k) Number: K120192 Product Name: Disposable Surgical Gowns Manufacturer: Weihai Hongyu Nonwoven Fabric Products Co., Ltd.

1. Non-Clinical Test Conclusion
  Non clinical tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the subject device complies with the following standards:
A ASTM D737-04 (2016) Standards Test Method for Air Permeability of Textile Fabrics
16 CFR 1610: 2008 Standard for the Flammability of Clothing Textiles
AATCC 127:2003 Water Resistance: Hydrostatic Pressure Test
AATCC 42:2007 Water Resistance: Impact Penetration Test
ISO 9073-10:2003 Textiles- Test Method for Nonwovens- Part 10: Lint and Other Particles Generation in the Dry State
ASTM D1683-11 Standard Test Method for Failure in Sewn Seams of Woven Apparel Fabrics
A ASTM D5587-15 Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure
ASTM D5034-09 (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

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Cytotoxicity

ISO 10993-10: 2010 Biological Evaluation of Medical Devices – Part 10: Tests for irritation and skin sensitization
1. Clinical Test Conclusion

No clinical study is included in this submission.

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Substantially Equivalent (SE) Comparison 8.

Item	Subject Device	Predicate Device 1	Predicate Device 2	SE Assessment
Product Code	FYA	FYA	FYA	Same
Regulation Number	878.4040	878.4040	878.4040	Same
Indications for Use	Surgical gown is intended to beworn by operating roompersonnel during surgicalprocedure to protect both thesurgical patient and the operatingroom personnel from transfer ofmicroorganisms, body fluids, andparticulate material.Per ANSI/AAMI PB70:2012Liquid barrier performance andclassification of protectiveapparel and drapes intended foruse in health care facilities, theAE series surgical gowns met therequirements for Level 2classification, the AG seriessurgical gowns met therequirements for Level 3classification.	Medline Disposable EclipseTMSurgical Gowns are surgicalapparel that are intended to beworn by operating roompersonnel during surgicalprocedures to protect both thesurgical patient and the operatingroom personnel from transfer ofbody fluids, micro-organisms,and particulate material.	Disposable Surgical Gowns,which are blue colored and EOsterilized, are indicated to be wornby operating room personnelduring surgical procedures toprotect both the surgical patientand the operating room personnelfrom transfer of microorganisms,body fluids, and particulatematerial. It culd achieve Level 3Barrier Performance as per AAMIPB70:2003. It is for single useonly.	Similar

Table 2 Comparison of Technology Characteristics

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Style		Non-reinforced/Fabric-reinforced/Poly-reinforced	Non-reinforced/Fabric-reinforced/Poly-reinforced	Reinforced	Same
Size		XL	L, XL,XXL	M, L, XL, XXL	See note belowDifference 1
Physicalspecification	Barrierprotectionlevel	Level 2/Level 3 per AAMI PB70	Level 2 per AAMI PB70	Level 3 per AAMI PB70	Same
	Tearingstrength	>30N	Not known	Not known	See note belowDifference 2
	Fireprotection	Class I	Not known	Class I	Same
	Lint:	$Log_{10}< 4$	Not known	Not known	See note belowDifference 3
	AirPermeability	>30 ft3/min/ft2	Not known	Not known
Mechanical	Tensilestrength	≥20N	Not known	≥20N	Same
specifications	Durability	Disposable	Disposable	Disposable	Same
Material		SMMMS, Polypropylene, PE(Poly Ethylene), Polyester	SMS	SMS, SPP, Polypropylene, PE,Nylon, Polyester	See note belowDifference 4
Biocompatibility		Under the conditions of the study, the device is non-toxic,	Under the conditions of the study, the device is non-toxic,	Under the conditions of the study, the device is non-toxic,	Same
non-irritating,non-sensitizing.	and	non-irritating,non-sensitizing.	and	non-irritating,non-sensitizing.	and

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Difference 1

The subject devices only have one size of XL, while the predicate device 1 has three kinds of sizes which are L. XL, XXL, and the predicate device 2 has four kinds of device which are M, L, XL, XXL. The difference in the size will not affect the function. So the difference in the size will not affect the safety and effectiveness of the subject device.

Difference 2

Although the tearing strength of the predicate devices are unknown, the subject device is large enough for safety using. Therefore this different will not raise new safety and effectiveness questions.

Difference 3

Although the linting level of the predicate devices are unknown, the linting levice is acceptable for safety using. Therefore this different will not raise new safety and effectiveness questions.

Difference 4

The main material of the subject device is SMMS, and the Predicate Device 1 and Predicate Device 2 is SMS, the difference between the material of the subject devices is the amounts of the meltblown layers. Therefore, this difference will not affect the substantially equivalency of the subject device.

Conclusion 9.
Based on the results of the nonclinical testing, the Surgical Gowns are as safe and as performs as well as the K043585 and K120192 predicate 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.