Surgical gowns are intended to be worn by operating room personnel procedure to protect both the surgical patient and the operating room persomel from transfer of microorganisms, body fluids, and particulate material. This device is provided sterile.

Per ASNI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the standard (non-reinforced) surgical gowns meet Level 2 classification and the reinforced surgical gowns meet Level 3 classification.

Device Description

Surgical gowns are intended to be worn by healthcare professionals to protect both the patient and the healthcare professional from the transfer or microorganisms, body fluids, and particulate material. The proposed devices are single use, disposable medical devices and ethylene oxide (EO) sterilized. They are available in six sizes: S, M, L, XL, XXL and XXXL.

The proposed surgical gowns are constructed of a Spunbond (SMS) nonwoven material, with cuffs made of polyester and elastic, offered in standard (non-reinforced) and reinforced surgical gowns, in blue color.

AI/ML Overview

This is a 510(k) summary for a surgical gown, which is a low-risk medical device. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of AI algorithm performance. Therefore, many of the requested criteria, which are typically relevant for AI/ML device evaluations, are not applicable here.

Here's an analysis based on the provided document:

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

The document provides a summary of performance testing in Table 2, outlining the test method, purpose, acceptance criteria, and result (Pass/Fail or specific finding).

Test Method	Purpose	Acceptance Criteria	Result
AATCC 127	Hydrostatic pressure	Level 2 > 20 cm, Level 3 > 50 cm	Pass
AATCC 42	Impact penetration	≤1g	Pass
ASTM F 2407 (ASTM D 5034)	Tensile Strength	Length Direction ≥ 115N, Width Direction ≥ 115N	Pass
ASTM D 5587	Tearing strength by Trapezoid	Length Direction > 20 N, Width Direction > 20 N	Pass
ASTM D 1683	Seam strength	≥ 20 N	Pass
16 CFR Part 1610	Flammability of Textiles	Class 1	Class 1
ISO 10993-7	Ethylene oxide residues	EO residual ≤ 4 mg/device, ECH residual ≤ 9 mg/device	Pass
ISO 9073-10	Linting	Log10 <4	Pass
Biocompatibility (ISO 10993-5)	Cytotoxicity	ISO 10993-5:2009	Under the conditions of the study, the proposed device extract was determined to be non-cytotoxic
Biocompatibility (ISO 10993-10)	Irritation	ISO 10993-10:2010	Under the conditions of the study, the proposed device extract was determined to be non-irritating
Biocompatibility (ISO 10993-10)	Sensitization	ISO 10993-10:2010	Under the conditions of the study, the proposed device extract was determined to be non-sensitizing

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document relates to non-clinical performance testing of a physical medical device (surgical gown) against established standards. It does not involve a "test set" in the context of data for an AI/ML algorithm. Therefore, information about data provenance, retrospective/prospective studies, and sample sizes for data are not applicable. The tests were likely conducted on a sample of the manufactured gowns.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable. The testing involves standardized laboratory methods (e.g., AATCC, ASTM, ISO standards) to measure physical and chemical properties of the surgical gown, not expert review or interpretation of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable. There is no "test set" of data requiring expert adjudication, as the conformity is based on objective laboratory measurements against defined standards.

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 is not applicable. The device is a surgical gown, not an AI/ML diagnostic or assistive tool for human readers.

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

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

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

The "ground truth" for this device's performance is defined by the acceptance criteria within the international and national consensus standards listed (e.g., AATCC 127, ASTM F 2407, ISO 10993-5). The device's physical and biological properties were measured and compared directly to these established benchmarks.

8. The sample size for the training set

This is not applicable. The document describes a physical medical device, not an AI/ML algorithm that requires training data.

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

This is not applicable, as there is no training set for an AI/ML algorithm.

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 & Human Services logo on the left and the FDA acronym and full name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.

February 16, 2023

Bayteks Teknik Tekstil San. ve Tic. A.S. % Sarah Fitzgerald Senior Consultant, Quality and Regulatory Affairs Emergo by UL 2500 Bee Cave Road, Building 1 Suite 300 Austin, Texas 78746

Re: K213844

Trade/Device Name: Surgical Gown Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: February 13, 2023 Received: February 15, 2023

Dear Sarah Fitzgerald:

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.

{1}------------------------------------------------

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 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.

Bifeng Qian -S

Bifeng Oian, MD, 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K213844

Device Name Surgical Gown

Indications for Use (Describe)

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

SURGICAL GOWN

K213844

The following information is provided in accordance with 21 CFR 807.92 for the premarket 510(k) summary:

1. Submission Sponsor

Bayteks Teknik Tekstil San. Ve Tic. A.S. Organize Sanaji Bolgesi 19. Nolu Cad. No. 9 Merkez, Kilis 79000 Turkey Contact: Spero Hegbe, Export Sales Specialist Telephone: 90 (530) 149 34 63 Fax: 90 (348) 834 10 28 sperohegbe@baymed.com.tr

2. Submission Correspondent

Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: (512) 327-9997 Email: LST.AUS.ProjectManagement@ul.com Contact: Sarah Marie Fitzgerald, Senior Consultant, Quality and Regulatory Affairs

3. Date Prepared

February 15, 2023

4. Device Identification

Trade/Proprietary Name:	Surgical Gown
Common/Usual Name:	Surgical Gown
Regulation Number:	21 CFR 878.4040
Product Code:	FYA
Class:	II
Review Panel:	General Hospital

5. Legally Marketed Predicate and Reference Devices

Predicate Device name: Surgical Gown 510(k) number: K202706

{4}------------------------------------------------

Manufacturer: B.J.ZH.F. Panther Medical Equipment Co., Ltd.

Reference Device name: Medline Surgical Gown 510(k) number: K190950 Manufacturer: Medline Industries, Inc.

6. Indication for Use Statement

Surgical gowns 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. This device is provided sterile.

Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities, the standard (non-reinforced) surgical gowns meet Level 2 classification and the reinforced surgical gowns meet Level 3 classification.

7. Device Description

8. Comparison of technological characteristics with the Predicate

The following table compares the subject device to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance, and forms the basis for the determination of substantial equivalence. The subject device does not raise any new questions of safety or effectiveness as compared to the predicate device.

Attribute	Subject GownK213844	Predicate GownK202706	Reference DeviceK190950	Comparison
Product Code	FYA	FYA	FYA	Same
RegulationNumber	878.4040	878.4040	878.4040	Same
Class	II	II	II	Same
Intended Use	To protect both patientsand healthcarepersonnel from the	To protect both patientsand healthcare personnelfrom the transfer of	To protect bothpatients andhealthcare personnel	Same

Table 1 – Comparison of Technological Characteristics
-------------------------------------------------------	--	--

{5}------------------------------------------------

Attribute	Subject GownK213844	Predicate GownK202706	Reference DeviceK190950	Comparison
	transfer ofmicroorganisms, bodyfluids, and particulatematerial.	microorganisms, bodyfluids, and particulatematerial.	from the transfer ofmicroorganisms,body fluids, andparticulate material.
Indication forUse	Surgical gowns areintended to be worn byoperating roompersonnel duringsurgical procedures toprotect both thesurgical patient and theoperating roompersonnel from transferof microorganisms,body fluids, andparticulate material.This device is providedsterile. Per ANSI/AAMIPB70:2012 Liquidbarrier performanceand classification ofprotective apparel anddrapes intended for usein health care facilities,the standard (non-reinforced) surgicalgowns meet Level 2classification and thereinforced surgicalgowns meet Level 3classification.	Surgical gowns areintended to be worn byoperating roompersonnel during surgicalprocedure to protectboth the surgical patientand the operating roompersonnel from transferof microorganisms, bodyfluids, and particulatematerial.Per ANSI/AAMIPB70:2012 Liquid barrierperformance andclassification ofprotective apparel anddrapes intended for usein health care facilities,the surgical gowns meetthe requirements forLevel 3 classification.	The [multiple namedgowns] are sterile, singleuse surgical apparelintended to be worn byhealthcare professionalsto help protect both thepatient and thehealthcare worker fromthe transfer ofmicroorganisms, bodyfluids, and particulatematter.The [gowns] meet therespective levelrequirements ofANSI/AAMI PB70:2012Liquid barrierperformance andclassification ofprotective apparel anddrapes intended for usein healthcare facilities.The [gowns] have beenvalidated using anethylene oxide (EtO)sterilization process. The[gowns] are also sold asbulk single use, non-sterile, torepackager/relabelerestablishments forfurther packaging andsterilization using thevalidated EtOsterilization methodaccording to ISO 11135-1prior to being providedto the end user.	Similar
Prescription orOTC	OTC	OTC	OTC	Same
Barrier Level(perANSI/AAMIPB70)	Standard: Level 2Reinforced: Level 3	Level 3	Standard: Level 2Reinforced: Level 3	Similar
Attribute	Subject GownK213844	Predicate GownK202706	Reference DeviceK190950	Comparison
Device Materials	SMS Polypropylenenonwoven, Polyester	SMS Polypropylenenonwoven, Polyester	SMS Polypropylenenonwoven, Polyester	Same
Device Design	Standard(nonreinforced) &Reinforced	Standard (nonreinforced)	Standard (nonreinforced)& Reinforced	Similar
Durability	Single-Use (Disposable)	Single-Use (Disposable)	Single-Use (Disposable)	Same
Sizes	Small (S), Medium (M),Large (L), Extra Large(XL), Extra Extra Large(XXL), Extra Extra ExtraLarge (XXXL)	Small (S), Medium (M),Large (L), Extra Large(XL), Extra Extra Large(XXL), Extra Extra ExtraLarge (XXXL)	Small (S), Medium (M),Large (L), Extra Large(XL), Extra Extra Large(XXL), Extra Extra ExtraLarge (XXXL)	Same
Color	Blue	Blue	Blue	Same
Flammability16 CFR Part 1610	Class I	Class I	Class I	Same
HydrostaticPressureAATCC 127	Level 2 > 20 cmLevel 3 > 50 cm	> 50 cm	-	Similar
ImpactPenetrationAATCC 42	<1.0 g water	<1.0 g water	-	Same
Tear StrengthASTM D 5587(TrapezoidProcedure)	Length Direction > 20 NWidth Direction > 20 N	> 20 N	-	Same
TensileStrengthASTM F 2407(ASTM D 5034)	Length Direction ≥ 115NWidth Direction ≥ 115N	> 20 N	-	Same
Seam StrengthASTM D1683	≥ 20 N	> 20 N	-	Same
LintingISO 9073-10	Log10 <4	Log10 <4	-	Same
SterilizationMethod	Ethylene Oxide	Ethylene Oxide Sterilizedand Non-Sterile Versions	-	Similar
EO and ECHResiduals	EO: not detectedECH: not detected	Passed	-	Same
BiocompatibilityCytotoxicityISO 10993-5	Non-cytotoxic	Non-cytotoxic	-	Same
Attribute	Subject GownK213844	Predicate GownK202706	Reference DeviceK190950	Comparison
BiocompatibilityIrritationISO 10993-10	Non-irritating	Non-irritating	-	Same
BiocompatibilitySensitization10993-10	Non-sensitizing	Non-sensitizing	-	Same

{6}------------------------------------------------

{7}------------------------------------------------

9. Non-Clinical Performance Data

Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrate that the proposed device complies with the following standards by passing all applicable acceptance criteria.

Test Method	Purpose	AcceptanceCriteria	Result
AATCC 127	Hydrostatic pressure	Level 2 > 20 cmLevel 3 > 50 cm	Pass
AATCC 42	Impact penetration	≤1g	Pass
ASTM F 2407(ASTM D 5034)	Tensile Strength	Length Direction ≥ 115NWidth Direction ≥ 115N	Pass
ASTM D 5587	Tearing strength byTrapezoid Procedure	Length Direction > 20 NWidth Direction > 20 N	Pass
ASTM D 1683	Seam strength	≥ 20 N	Pass
16 CFR Part 1610	Flammability of Textiles	Class 1	Class 1
ISO 10993-7	Ethylene oxide residues	EO residual ≤ 4 mg/deviceECH residual ≤ 9 mg/device	Pass
ISO 9073-10	Linting	Log10 <4	Pass
Biocompatibility	Cytotoxicity	ISO 10993-5:2009	ISO 10993-5; Under the conditions of thestudy, the proposed device extract wasdetermined to be non-cytotoxic
	Irritation	ISO 10993-10:2010	ISO 10993-10; Under the conditions of thestudy, the proposed device extract wasdetermined to be non-irritating
	Sensitization	ISO 10993-10:2010	ISO 10993-10; Under the conditions of thestudy, the proposed device extract wasdetermined to be non-sensitizing

Table 2 – Summary of Performance Testing

10. Clinical Performance Data

No clinical study is included in this submission.

{8}------------------------------------------------

11. 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 cleared under K202706.

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.