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. This is a single use, disposable device, provided sterile.

Device Description

The proposed device Disposable Surgical Gown is model UM-148, its body, sleeve and belt are made of SMMS non-woven material, and cuff is made of polyester. The proposed device is available in sizes: S(120×135cm), M(125×140cm), L(130×145cm) and XL(135×150cm). This proposed device can meet the requirements for Level 3 per ANSI/AAMI PB70:2012. The proposed devices are disposable medical devices and provided in sterile and a blue color.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, specifically a "Disposable Surgical Gown (UM-148)". This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. Therefore, the "acceptance criteria" and "study" described are about showing that the new surgical gown performs comparably to established standards and a predicate device, rather than proving a new clinical claim.

Here's an analysis of the provided information, formatted as requested:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria / Standard (Ref.)	Reported Device Performance
AAMI/ANSI PB70:2012, Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended For Use In Health Care Facilities. Level 3: When tested for water resistance in accordance with AATCC 42 (impact penetration) and AATCC 127 (hydrostatic pressure) and all critical zone components shall have a blotter weight gain of no more than 1.0 g and a hydrostatic pressure of >50 cm.	Level 3 (The device meets Level 3 requirements for Liquid Barrier Performance and Classification)
ASTM D5587-15, Standard Test Method for Tearing Strength of Fabrics by Trapezoid Procedure: ≥10 N	PASS MD: 45.5N CD: 28.2N (Average result from 10 samples)
ASTM D5034-09 (2017) Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test): ≥30N	PASS MD: 145.4N CD: 91.4N (Average result from 10 samples)
ASTM D1683M-17 Standard Test Method for Failure in Sewn Seams of Woven Fabrics: ≥30N	PASS 52.6N (Average result from 10 samples)
AATCC 42-2013, Water Penetration Resistance: Impact Penetration Test: ≤1.0 g	PASS 0 g (Average result from 3 nonconsecutive batches)
Evaporative Resistance ASTM F1868-17: < 3 Pa.m²/W.	PASS 2.36 Pa.m²/W. (Average result from 13 samples)
AATCC 127-2014, Water Resistance: Hydrostatic Pressure Test: >50 cm	PASS 65~72 cm (Average result from 3 nonconsecutive batches)
CPSC 16 CFR Part 1610-2008, Standard for the Flammability of clothing textiles: Meets Class I requirements	PASS Class I (Average result from 5 samples)
ISO 9073- 10:2003(E) Lint and Other Particles Generation: Log10(particle count) < 4	PASS 2.0 (Average result from 13 samples)
ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization: Non-irritating, and Non-sensitizing.	PASS Under the conditions of the study, the device is non-irritating, and non-sensitizing.
ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity: Non-cytotoxic.	PASS Under the conditions of the study, the device is non-cytotoxic.

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

Tearing Strength (ASTM D5587-15): 10 samples.
Breaking Strength and Elongation (ASTM D5034-09): 10 samples.
Failure in Sewn Seams (ASTM D1683M-17): 10 samples.
Water Penetration Resistance (AATCC 42-2013): 3 nonconsecutive batches.
Evaporative Resistance (ASTM F1868-17): 13 samples.
Water Resistance: Hydrostatic Pressure Test (AATCC 127-2014): 3 nonconsecutive batches.
Flammability (CPSC 16 CFR Part 1610-2008): 5 samples.
Linting (ISO 9073-10:2003(E)): 13 samples.
Biocompatibility (ISO 10993-10 and ISO 10993-5): Sample sizes for the specific in vitro and in vivo tests are not explicitly stated, but the tests were performed "under the conditions of the study".

The data provenance is from non-clinical tests conducted by or on behalf of Unimax Medical Products Co., Ltd. in China. These are prospective tests performed on the proposed device to demonstrate its performance against recognized industry standards.

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

Not applicable. This is a submission for a physical medical device (surgical gown) where performance is measured against established scientific and engineering standards for materials and protective properties, not based on expert interpretation of observational data. The "ground truth" is defined by the objective metrics specified in the test methodologies (e.g., N for strength, g for water penetration, cm for hydrostatic pressure).

4. Adjudication method for the test set

Not applicable. Performance is measured against quantitative and qualitative criteria defined by the respective standards, and the results are reported directly (e.g., "PASS", "45.5N"). There is no subjective interpretation or adjudication process involved as would be the case for image-based diagnostic AI, for example.

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

Not applicable. This is not an AI-enabled diagnostic device. It is a physical product (surgical gown).

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

Not applicable. This is not an AI-enabled diagnostic device.

7. The type of ground truth used

The ground truth is based on established industry standards and objective physical measurements. For example:

AAMI/ANSI PB70:2012 defines liquid barrier performance levels.
ASTM standards define methods and acceptance criteria for material strengths (tearing, breaking, seam).
AATCC standards define methods for water resistance.
CPSC 16 CFR Part 1610 defines flammability classes.
ISO 9073-10 defines linting criteria.
ISO 10993 standards define biocompatibility criteria based on in vitro (cytotoxicity) and in vivo (irritation, sensitization) tests.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set. The tests are directly measuring the physical properties of the manufactured product.

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

Not applicable. There is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 20, 2022

Unimax Medical Products Co., Ltd. % Jarvis Wu Consultant Shanghai SUNGO Management Consulting Company Limited. 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China

Re: K221717

Trade/Device Name: Disposable Surgical Gown UM-148 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: August 12, 2022 Received: August 12, 2022

Dear Jarvis Wu:

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

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Indications for Use

Submission Number (if known)

K221717

Device Name

Disposable Surgical Gown (UM-148)

Indications for Use (Describe)

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)

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Unimax Medical Products Co., Ltd. No.1 Liansai Road, Changshangkou Town, Xiantao City, Hubei Province, P.R. China.

510(K) Summary K221717

Document prepared date: 2022/9/15

A. Applicant:

Name: Unimax Medical Products Co., Ltd. Address: No.1 Liansai Road, Changshangkou Town, Xiantao City, Hubei Province, P.R. China. Contact Person: Ning Haibo Tel: +86-027 82213162 Mail: sales@unimaxmedical.com

Submission Correspondent: Primary contact: Mr. Jarvis Wu Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo 14th Floor, 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(s): UM-148

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

C. Predicate device:

K212591

Disposable Surgical Gown

Suzhou JaneE Medical Technology Co., Ltd.

D. Intended use /Indications for Use:

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Unimax Medical Products Co., Ltd. No.1 Liansai Road, Changshangkou Town, Xiantao City, Hubei Province, P.R. China.

E. Device Description:

The proposed devices are disposable medical devices and provided in sterile and a blue color.

F. Comparison with predicate device

Device	Predicate Device	Proposed Device	Comparison
Manufacturer	Suzhou JaneE MedicalTechnology Co., Ltd.	Unimax Medical Products Co.,Ltd.	-
510K number	K212591	K221717	-
Product Name	Disposable Surgical Gown	Disposable Surgical Gown	Same
Classification	Class II Device, FYA (21CFR878.4040)	Class II Device, FYA (21CFR878.4040)	Same
Intend use/Indications for Use	The Disposable SurgicalGowns are intended to beworn by operating roompersonnel during surgicalprocedures to protect thesurgical patient and operatingroom personnel from thetransfer of microorganisms,body fluids and particulatematter. This is a single use,disposable device, providedsterile.	The Disposable SurgicalGowns are intended to beworn by operating roompersonnel during surgicalprocedures to protect thesurgical patient and operatingroom personnel from thetransfer of microorganisms,body fluids and particulatematter. This is a single use,disposable device, providedsterile.	Same
MaterialComposition	Polyolefin (Polypropylene)SMS nonwoven	PolyesterSMMS non-woven	Similar. Noeffect onsafety orefficacy.Both passedbiocompatibility tests.
Sterility	Sterile	Sterile	Same
Use	Single Use; Disposable	Single Use; Disposable	Same
Color	Blue	Blue	Same
Size	M,L,XL,TL	S,M,L,XL	Similar. Noeffect onsafety orefficacy
Weight persquare(g)	Critical Area: 87.8g/m2Non-Critical Area: 45.12g/m2	45g/m2	Similar. Noeffect onsafety orefficacy.Both passedperformancetests.
Tensile(Breaking strength)	MD: 16.18 lbs (72N)CD: 13.26 lbs (59N)	MD: 145.4NCD: 91.4N	Similar. Noeffect onsafety orefficacy.Both passedperformancetests.
Tearing Strength	MD:22.25 lbs (99 N)CD:18.20 lbs (81N)	MD: 45.5NCD: 28.2N	Similar. Noeffect onsafety orefficacy.Both passedperformancetests.
Seam Strength	Sleeve Seam:68.3NSide Seam:69.7NBelt Seam:71N	52.6N	Similar. Noeffect onsafety orefficacy.Both passedperformancetests.
HydrostaticPressure(cm)AATCC-127	>50 cm	>50 cm	Same
Water Impact (g)AATCC-42	≤1.0 g	≤1.0 g	Same
Liquid barrierperformance	Level 3 AAMI PB70	Level 3 AAMI PB70	Same
Flammability	Class I	Class I	Same
Linting	Log10(particle count) < 4	Log10(particle count) < 4	Same
EvaporativeResistance	< 3 Pa.m²/W.	< 3 Pa.m²/W.	Same
Sterilizationmethod	Ethylene oxide	Ethylene oxide	Same
Ethylene oxideresiduals	EO:<4mg/d ECH:<9mg/d	EO:<4mg/d ECH:<9mg/d	Same
Biocompatibility	Under the conditions of the study, the device extract was notcytotoxic.	Under the conditions of the study, the non-polar and polardevice extracts were not found to be an irritant.	Same
	Under conditions of the study, the non-polar and polar deviceextracts were not found to be a sensitizer.

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Unimax Medical Products Co., Ltd. No.1 Liansai Road, Changshangkou Town, Xiantao City, Hubei Province, P.R. China.

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Unimax Medical Products Co., Ltd. No.1 Liansai Road, Changshangkou Town, Xiantao City, Hubei Province, P.R. China.

Analvsis

The subject surgical gown is similar to the predicate device, in terms of general intended use, performance testing, material composition, and configuration. The tearing strength, breaking strength and seam strength are slightly different from those of the predicate device. The proposed device has been tested according to ASTM D5587-15, ASTM D5034-09 (2017) and ASTM D1683/D1683M-17(2018) respectively, and met the requirements of the standard.

Under the conditions of each study, the subject surgical gowns is non-cytotoxic, non-sensitizing and negligibly irritating per ISO-10993 and have met the requirements of ANSI/AAMI PB70:2012 Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities for AAMI Level 3 surgical gowns.

G. Non-Clinical Test Conclusion

Non-clinical tests were conducted to verify that the proposed device met all design specifications. The subject surgical gown was assessed for performance using the following Standards and Test Methods. The test results demonstrated that the proposed device met its acceptance criteria or testing endpoints.

Test Methodology	Purpose	Acceptance Criteria	Results
AAMI/ANSIPB70:2012, LiquidBarrier Performanceand Classification ofprotective Apparel andDrapes Intended ForUse In Health CareFacilities.	The tests wereperformed to determinethe classification ofsubject surgical gownproduct.	Level 3: When testedfor water resistance inaccordance withAATCC 42 (impactpenetration) andAATCC 127(hydrostatic pressure)and all critical zonecomponents shallhave a blotter weightgain of no more than1.0 g and a hydrostatic	Level 3

ASTM D5587-15,Standard Test Methodfor Tearing Strength ofFabrics by TrapezoidProcedure	The test was performedin accordance withASTM D5587:2015(2019) StandardTest Method forTearing Strength ofFabrics by TrapezoidProcedure to evaluatethe tearing strength ofthe test sample.	≥10 N	PASSMD: 45.5NCD: 28.2N(Average result from 10samples)
ASTM D5034-09(2017) Standard TestMethod for BreakingStrength andElongation of TextileFabrics (Grab Test)	The test was performedIn accordance withD5034-09 (2017) .Standard. Test Methodfor Breaking Strengthand Elongation ofTextile Fabrics (GrabTest) to evaluate thebreaking strength of thetest sample.	≥30N	PASSMD: 145.4NCD: 91.4N(Average result from 10samples)
ASTM D1683M-17Standard Test Methodfor Failure in SewnSeams of WovenFabrics.	The test was performedIn accordance withASTM D1683M-17Standard. Test Methodfor Seam Strength ofTextile Fabrics (GrabTest) to evaluateFailure in Sewn Seamsof the test sample.	≥30N	PASS52.6N(Average result from 10samples)
AATCC 42-2013,Water PenetrationResistance: ImpactPenetration Test;	The test was performedin accordance withAATCC 42: 2013Water Resistance:Impact Penetration Testto evaluate the waterimpact of the testsample.	≤1.0 g	PASS0 g(Average result from 3nonconsecutive batches)
Evaporative ResistanceASTM F1868-17	The test was performedin accordance withASTM F1868-17 toevaluate theEvaporative Resistanceof the test samples	< 3 Pa.m²/W.	PASS2.36 Pa.m²/W.(Average result from 13samples)

AATCC 127-2014,Water Resistance:Hydrostatic PressureTest;	The test was performedin accordance withAATCC 127: 2014Water Resistance:Hydrostatic PressureTest to determine thehydrostatic pressure ofthe test sample.	>50 cm	PASS65~72 cm(Average result from 3nonconsecutive batches)
CPSC 16 CFR Part1610-2008, Standardfor the Flammability ofclothing textiles	The test was performedin accordance with 16CFR Part 1610Standard for theFlammability ofClothing Textiles toevaluate theflammability of the testsample.	Meets Class Irequirements	PASSClass I(Average result from 5samples)
ISO 9073- 10:2003(E)Lint and Other ParticlesGeneration	The test was performedin accordance with ISO9073-10: 2003 Textiles-Test Methods forNonwovens-Part 10:Lint and Other ParticlesGeneration in the DryState to evaluate thelinting of the testsample.	Log10(particle count) < 4	PASS2.0(Average result from 13samples)
ISO 10993-10: 2010Biological Evaluationof Medical Devices -Part 10: Tests ForIrritation And SkinSensitization	The purpose of thebiocompatibility testingis to demonstrate thebiocompatibility of thesubject device.	Non-irritating, andNon-sensitizing.	PASSUnder the conditions ofthe study, the device isnon-irritating, and non-sensitizing.
ISO 10993-5: 2009Biological Evaluationof Medical Devices --Part 5: Tests For InVitro Cytotoxicity	The purpose of thebiocompatibility testingis to demonstrate thebiocompatibility of thesubject device.	Non-cytotoxic.	PASSUnder the conditions ofthe study, the device isnon-cytotoxic.

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H. Clinical Test Conclusion

No clinical study is included in this submission.

I. Conclusion

Based on the comparison and analysis above, the subject device, Disposable Surgical Gown(model UM-148), is as safe, as effective, and performs as well as the legally marketed predicate device, Disposable Surgical Gowns cleared under K212591.

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.