The Disposable Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate matter.

In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). This is a single use, disposable device, provided sterile. The surgical gown has six sizes - S, M, L, XL, XXL and XXXL.

Device Description

The Disposable surgical gown is composed of collar, body, sleeve and tie. The back is full opening, the neck and waist are laced, the sleeve are made of cotton closure by sewing, and the rest are made of heat sealing. It has been tested according to AAMI PB70:2012 and meet AAMI Level 3 barrier level protection for a surgical gown.

AI/ML Overview

The document details the non-clinical testing performed for the Disposable Surgical Gown (G4003) to support its substantial equivalence claim.

1. Table of acceptance criteria and the reported device performance

Test Methodology	Purpose	Acceptance Criteria	Reported Device Performance
Tearing Strength	Evaluate the tearing strength of the test sample.	≥ 10N	Pass: MD: average 52.03N, CD: average 29.15N
Tensile Strength	Evaluate the breaking strength of the test sample.	≥ 30N	Pass: MD: average 135.83N, CD: average 98.25N
Seam Strength	Evaluate the seam strength of the test sample.	≥ 30N	Pass: Average 45.18N
Impact Penetration	Evaluate the water impact of the test sample.	≤1.0 g	Pass: 0.16g max
Hydrostatic Pressure	Determine the hydrostatic pressure of the test sample.	>50 cm	Pass: 52~98cm
Thermal and Evaporative Resistance	Evaluate the evaporative resistance of the test sample.	< 3 Pa.m²/W.	Pass: 0.00542 Pa.m²/W
Linting	Evaluate the linting of the test sample.	Log10 <4	Pass: Average 2.2
Flammability	Evaluate the flammability of the test sample.	Class 1	Pass: Class 1
EO/ECH residue	Evaluate the level of sterilant residues.	EO: < 10 ug/cm²ECH: < 10 mg/device	EO: not detectedECH: Average 6.8 ug/device
In Vitro Cytotoxicity (ISO 10993-5)	Demonstrate the safety of the subject device.	Non-cytotoxic	Under the conditions of the study, the device is non-cytotoxic.
Irritation and Skin Sensitization (ISO 10993-10)	Demonstrate the safety of the subject device (purpose not explicitly stated for irritation/sensitization but implied for biocompatibility).	Non-irritatingNon-sensitizing	Under the conditions of the study, the device is non-irritating and non-sensitizing.

2. Sample size used for the test set and the data provenance

The document does not explicitly state the sample sizes for each specific non-clinical test. However, the tests are performed according to recognized international and national standards (e.g., ASTM, AATCC, ISO, CPSC). Data provenance is from Xiantao Topmed Nonwoven Protective Products Co., Ltd. located in Hubei Province, China, likely from prospective testing specifically conducted for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable as the document describes non-clinical performance and biocompatibility testing of a physical product (surgical gown), not a diagnostic or AI device that requires expert ground truth establishment. The "ground truth" for these tests is defined by the objective measurement criteria within the specified standards.

4. Adjudication method for the test set

This section is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical studies involving multiple readers, not for objective non-clinical performance testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable. The device is a physical surgical gown, not an AI or diagnostic tool, so no MRMC study was conducted or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For these non-clinical tests, the "ground truth" is established by objective measurements and results obtained from standardized testing methodologies, as defined by the various ASTM, AATCC, ISO, and CPSC standards cited (e.g., tearing strength in Newtons, impact penetration in grams, hydrostatic pressure in cm).

8. The sample size for the training set

This section is not applicable. The device is a physical surgical gown. There is no concept of a "training set" as there would be for an AI or machine learning model.

9. How the ground truth for the training set was established

This section is not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.

October 20, 2022

Xiantao Topmed Nonwoven Protective Products Co., Ltd. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Century Avenue Shanghai, 200122 China

Re: K221977

Trade/Device Name: Disposable Surgical Gown (G4003) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: September 19, 2022 Received: September 19, 2022

Dear Ivy Wang:

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.

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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 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.

Bifeng Qian, M.D., 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 Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221977

Device Name Disposable Surgical Gown (G4003)

Indications for Use (Describe)

In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSU AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). This is a single use, disposable device, provided sterile. The surgical gown has six sizes - S, M, L, XL, XXL and XXXL.

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)

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510(K) Summary (K221977)

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

Prepared date: 2022-04-28 A. Applicant: Xiantao Topmed Nonwoven Protective Products Co., Ltd Address: North of the National Road 318, Tongjiazui Village, Huchang Town, Xiantao City, Hubei Province, China 433000 Contact Person: Vivian Zhu Tel: + 862787861070 Fax: +862787861011 Email: info@topmeddisposable.com

Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com

B. Device:

Trade Name: Disposable Surgical Gown Common Name: Surgical Gown Model: G4003

Regulatory Information Classification Name: Gown, Surgical Classification: Class II Product code: FYA Regulation Number: 878.4040 Review Panel: Surgical Apparel

C. Predicate device:

K211809 Surgical Gown Wuhan Dymex Healthcare Co., Ltd.

D. Indications for use of the device:

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E. Device Description:

Item	Proposed Device	Predicate Device	Result
510K number	-	K211809	-
Model name	Disposable Surgical Gown	Surgical Gown	Similar
Classification	Class II Device, FYA (21 CFR878.4040)	Class II Device, FYA (21 CFR878.4040)	Same
Intended use	The Disposable Surgical Gowns are intended to be worn by operating room personnel during surgical procedures to protect the surgical patient and operating room personnel from the transfer of microorganisms, body fluids and particulate matter.In addition, this surgical gown meets the requirements of AAMI Level 3 barrier protection for a surgical gown per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (AAMI PB70). This is a single use, disposable device, provided sterile.	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.	Same
Style	Non-reinforced	Non-reinforced	Same
Color	Blue	Blue	Same

F. Comparison with predicate device

Table 1 General Comparison

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Use	Single Use, Disposable	Single Use, Disposable	Same
-----	------------------------	------------------------	------

Table 2 Technological comparison

Item	Proposed Device	Predicate Device (K211809)	Result
Size	S, M, L, XL, XXL, XXXL	S, M, L, XL, XXL, XXXL	Same
Material	SMMS nonwovenPolypropylene, Cotton, Nylon	SMS, Polyester, Nylon	Different
Weight per square(g)	45g/m2	43g/m2	Different
Impact Penetration	<1.0g	<1.0g	Same
HydrostaticResistance	>50cmH2O for critical zone	>50cmH2O for critical zone	Same
Tensile Strength	MD: average 135.83NCD: average 98.25N	MD: Average 74.88CD: Average 50.73	Similar
Tear Strength	MD: average 52.03NCD: average 29.15N	MD: Average 63.87CD: Average 34.91	Similar
Seam Strength	Average 45.18N	Not available	Different
Linting	Log10≤4	Log10≤4	Same
EvaporativeResistance	< 3 Pa.m2/W	Not available	Different
Flammability	Class 1, Non Flammable	Class 1, Non Flammable	Same
Resistance to bloodandliquid penetration	Level 3 per PB70	Level 3 per PB70	Same
Cytotoxicity	Comply with ISO 10993-5	Comply with ISO 10993-5	Same
Irritation	Comply with ISO 10993-10	Comply with ISO 10993-10	Same
Sensitization	Comply with ISO 10993-10	Comply with ISO 10993-10	Same
Sterility	Sterile	Sterile	Same
Sterilization	EO methodSAL: 10-6	EO methodSAL: 10-6	Same

G. Non-Clinical Test Conclusion

Non-clinical tests were conducted to verify that the proposed device met all design specification as same/similar to the predicate device. The test results demonstrated that the proposed device comply with the Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes and the following standards.

16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
ASTM F2407: 2020 Standard Specification for Surgical Gowns Intended for Use in Healthcare

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Facilities

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 F1868: 2017 Test Method for Thermal and Evaporative Resistance of Clothing Materials Using a Sweating Hot Plate;
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:

Test Methodology	Purpose	AcceptanceCriteria	Result
Tearing Strength	The test was performed inaccordance with ASTMD5587:2015(2019) StandardTest Method for TearingStrength of Fabrics byTrapezoid Procedure toevaluate the tearing strengthof the test sample.	$\geq$ 10N	PassMD: average 52.03NCD: average 29.15N
Tensile Strength	The test was performed inaccordance with ASTM D5034:2009(2017) StandardTest Method for BreakingStrength and Elongation ofTextile Fabrics (Grab Test)to evaluate the breakingstrength of the test sample.	$\geq$ 30N	PassMD: average 135.83NCD: average 98.25N
Seam Strength	The test was performed inaccordance with ASTMD1683M-17 Standard Test	$\geq$ 30N	PassAverage 45.18N
	Method for Failure in SewnSeams of Woven Fabrics toevaluate the seam strength ofthe test sample.
Impact Penetration	The test was performed inaccordance with AATCC 42:2017 Water Resistance:Impact Penetration Test toevaluate the water impact ofthe test sample.	≤1.0 g	Pass0.16g max
Hydrostatic Pressure	The test was performed inaccordance with AATCC127: 2017 Water Resistance:Hydrostatic Pressure Test todetermine the hydrostaticpressure of the test sample.	>50 cm	Pass52~98cm
Thermal andEvaporativeResistance	The test was performed inaccordance with ASTMF1868: 2017 Test Methodfor Thermal and EvaporativeResistance of ClothingMaterials Using a SweatingHot Plate to evaluate theevaporative resistance of thetest sample.	<3 Pa.m²/W.	Pass0.00542 Pa.m²/W
Linting	The test was performed inaccordance with ISO9073-10:2003 Textiles-TestMethods for Nonwovens-Pat10: Lint and Other ParticlesGeneration in the Dry Stateto evaluate the linting of thetest sample.	Log10 <4	PassAverage 2.2
Flammability	The test was performed inaccordance with CPSC 16CFR Part 1610-2008standard for theFlammability of clothingtextiles to evaluate theflammability of the testsample	Class 1	PassClass 1
EO/ ECH residue	The test was performed inaccordance with ISO10993-7:2008 Biological	EO: < 10ug/cm²ECH: < 10	EO: not detectedECH: Average 6.8ug/device

	evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals to evaluate the level of sterilant residues.	mg/device

Table 3 Performance testing

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Xiantao Topmed Nonwoven Protective Products Co., Ltd North of the National Road 318, Tongjiazui Village, Huchang Town, Xiantao City, Hubei Province, China 433000

Table 4 biocompatibility testing

Test Methodology	Purpose	AcceptanceCriteria	Result
ISO 10993-5: 2009BiologicalEvaluation ofMedical Devices --Part 5: Tests For InVitro Cytotoxicity	The purpose of the testingis to demonstrate the safetyof the subject device.	Non-cytotoxic	Under the conditionsof the study, thedevice isnon-cytotoxic.
ISO 10993-10: 2010BiologicalEvaluation ofMedical Devices -Part 10: Tests ForIrritation And SkinSensitization		Non-irritatingNon-sensitizing	Under the conditionsof the study, thedevice isnon-irritating.Under the conditionsof the study, thedevice isnon-sensitizing.

H. Clinical Test Conclusion

No clinical study is included in this submission.

I. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device K211809.

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.