The Bodygard SFS Surgical Gown Level 4 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, Bodygard SFS Surgical Gown Level 4 met the requirements for Level 4 classification.

Device Description

The Bodygard SFS Surgical Gown Level 4 is a single use poly reinforced surgical gown, SMS Nonwoven/Film/SMS Nonwoven (SFS) that provides AAMI Level 4 liquid barrier protection in the critical zones (arms and chest) and non-critical zones of the gown. The Bodygard SFS Surgical Gown Level 4 is manufactured using ultrasonic bonding technique are available in the color blue and four different sizes (M, L, XL, and XXL).

Per ANSI/AAMI PB70:2012 Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities. The Bodygard SFS Surgical Gown Level 4, meets the requirements for Level 4 classification, are disposable medical devices and provided in sterile.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, which is a Bodygard SFS Surgical Gown Level 4. This type of document focuses on demonstrating that a new device is "substantially equivalent" to predicate devices already on the market, rather than establishing a completely new safety and effectiveness profile from scratch.

Therefore, the study design elements typically associated with proving an AI/clinical diagnostic device meets acceptance criteria (like sample size for test sets, expert qualifications, adjudication methods, MRMC studies, and ground truth for training data) are not applicable to this document. This document describes the testing of a physical medical device (a surgical gown) against established performance standards for such products.

Here's a breakdown based on the information provided, focusing on what is relevant for this specific device:

1. Table of acceptance criteria and the reported device performance:

Test Method	Acceptance Criteria	Reported Device Performance
AATCC 127 (Water resistance, Hydrostatic Pressure)	>50 cm H2O (AQL 4%, RQL=20%)	All test samples were > 50 cm H2O
AATCC 42 (Water Resistance impact penetration)	<1.0 g penetration (AQL 4%, RQL=20%)	All test samples were < 1 g penetration
ASTM D 5034-09 (Breaking Strength)	>30 N (AQL 4%, RQL=20%)	All test samples were >30N
ASTM D5587-14 (Tearing Strength)	>20 N (AQL 4%, RQL=20%)	All test samples were >20 N
16 CFR 1610 (Flammability testing)	Class I	Meets Class I
ASTM D1683-17 (Seam Strength)	>50 N (AQL 4%, RQL=20%)	All test samples were >50 N
D6701-16 (Water vapor transmission of Nonwoven and plastic Barriers)	>500 g/m² Day WVTR	Passed
ASTM D3776/D (Mass Per Area (Weight) of fabric)	Has met acceptance criteria according to ASTM F2407	Has met acceptance criteria according to ASTM F2407
ASTM F1670 (Resistance by synthetic Blood)	No Penetration at 2 psi (13.8 kPA)	Passed
ASTM F1671 (Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens)	No detectable transfer of the Phi-X174 Bacteriophage	Passed
ISO 9073-10:2003 (Lint and Other particles generation in the dry state)	Log 10 < 4	Below Log10<4 Passed
ASTM D4169-16 (Performance testing of shipping containers and systems)	Products must withstand the distribution environment	Passed
ASTM F88-07A (Seal strength of Flexible Barrier Materials)	Package Seal integrity must be intact.	Passed
ASTM F2096-04 (Detecting Gross Leaks in medical packaging by internal pressurization (Bubble test))	Package integrity must be intact without failed seal locations.	Passed
ASTM F1980-07 (Accelerated Aging of Sterile Barrier Systems for medical devices)	Package integrity must be intact after accelerated aging	Passed
ISO 10993-5 (Biological Evaluation of medical devices - Part 5: tests for In vitro cytotoxicity of medical devices)	Device must not be cytotoxic	Under the condition of the testing, the device is non-cytotoxic
ISO 10993-10 (Biological Evaluation of medical devices - Part 10: Tests for irritation and skin sensitization / Irritation)	Device must not be irritant	Under the condition of the testing, the device is not an irritant
ISO 10993-10 (Biological Evaluation of medical devices - Part 10: Tests for irritation and skin sensitization/sensitization)	Device must not be sensitizer	Under the condition of the testing, the device is not a sensitizer
ISO 10993-7 (Biological Evaluation of medical devices- Part 7: Ethylene Oxide Sterilization Residuals)	Residual Ethylene oxide levels must be below limits EO <4 mg/device. The device met requirements of ISO 1099-7:2008	Ethylene Oxide residual levels are below limitations. Data not available, required to meet the requirements of ISO 10993-7:2008

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

The document does not explicitly state the sample size for each specific test or the data provenance (e.g., country of origin, retrospective/prospective). The testing was conducted "in alignment with 'Guidance on Premarket Notification 510(k) Submissions for Surgical Gowns and Surgical' Guidance Document." The reported results for each test (e.g., "All test samples were > 50 cm H2O") indicate that multiple samples were tested as per the respective standard's requirements, but the exact number isn't quantified.

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

This information is not applicable as the device is a physical surgical gown, not an AI/clinical diagnostic device requiring expert interpretation for ground truth establishment. The "ground truth" is determined by established physical, chemical, and biological testing standards.

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

This is not applicable for the reasons stated in point 3.

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 as the device is a physical surgical gown. No human readers or AI assistance are involved in its performance evaluation.

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

This is not applicable as the device is a physical surgical gown, not an algorithm.

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

For this device, the "ground truth" for its performance is based on established international and national standards for physical and biological properties of protective apparel. These standards define the acceptable range or value for each characteristic (e.g., specific hydrostatic pressure, tear strength, absence of cytotoxicity).

8. The sample size for the training set:

This is not applicable as the device is a physical surgical gown and does not involve a training set as understood in machine learning/AI.

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

This is not applicable for the reasons stated in point 8.

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, 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.

November 10, 2022

Feliks Plastik Laminasyon Ve Ambalaj Malzemeleri % Darren Reeves President DP Distribution & Consulting, LLC 12240 Hunting Horn Lane Rockville, Virginia 23146

Re: K221139

Trade/Device Name: Bodygard SFS Surgical Gown Level 4 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: October 7, 2022 Received: October 11, 2022

Dear Darren Reeves:

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 -S

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 Ouality Center for Devices and Radiological Health

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K221139

Device Name Bodygard SFS Surgical Gown Level 4

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)

PSC Publishing Services (301) 443-6740

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

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K221139 510(k) Summary Traditional 510(k)

In accordance with 210 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Bodygard SFS Surgical Gown Level 4 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.

Sponsor:	Feliks Plastik Lam Ve Amb Mal San Ve Tic A. S.Eskishir Organize Sanayi Bolgesi 26. Cad No. 9 26110Eskisehir
	Ali Serdar SerteserFelix@felixplastic.com+90 533 209 72 95Eskisehir Industrial Zone 26st No 9Odunpazari, Eskisehir Turkey
Contact Person/Prepared by:	Darren ReevesPresidentDP Distribution & Consulting, LLC ®(804) 307-7706dreeves@dpdconline.com12240 Hunting Horn LaneRockville, Virginia 23146
Preparation Date:	11/08/2022
Subject Device:	Trade Name: Bodygard SFS Surgical Gown Level 4510(k) #: K221139Common Name: Surgical GownClassification Name: Surgical Gown (21 CFR 878.4040,Product Code FYA)
Predicate Device:	Disposable Surgical Gown, Disposable Reinforced SurgicalGown (K212869)

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Device Description:

Intended Use and Indication for Use:

Comparison of Predicate Device:

Elements ofComparison	Proposed DeviceBodygard SFS SurgicalGown Level 4	Predicate Device K212869Disposable Surgical Gown,Disposable Reinforced SurgicalGown (Sterile)	Remark
510 (k) Number	K221139	K212869	N/A
Product Code	FYA	FYA	Same
RegulationNumber	21CFR 878.4040	21CFR 878.4040	Same
Indication for Use
	The Bodygard SFS SurgicalGown Level 4 is intendedto be worn by operatingroom personnel duringsurgical procedure to pro-tect both the surgical pa-tient and the operatingroom personnel fromtransfer of microorgan-isms, body fluids,and particulate material.Per ANSI/AAMI PB70:2012Liquid barrier performanceand classification of pro-tective apparel and drapesintended for use in healthcare facilities, BodygardSFS Surgical Gown Level 4met the requirements forLevel 4 classification.	Disposable Surgical Gown andDisposable Reinforced SurgicalGown are intended to be worn byoperating room personnel duringsurgical procedure to protectboth the surgical patient and theoperating room personnel fromtransfer of microorganisms, bodyfluids, and particulate material.Per ANSI/AAMI PB70:2012 Liquidbarrier performance and classifi-cation of protective apparel anddrapes intended for use in healthcare facilities, Disposable SurgicalGown ML515M45U met the re-quirements for Level 3 classifica-tion, Disposable Surgical GownGD524ME65 and Disposable Re-inforced Surgical Gown met therequirements of Level 4 classifi-cation.	Similar
Style	Poly Reinforced	Non-reinforced/Reinforced	Similar
Durability	Disposable	Disposable	Same
Color	Blue	Blue	Same
Material	Complete gown has 4 com-ponents/Component AFabric SMS Nonwoven/Lamination ReinforcementFilm/SMS Nonwoven(SFS)/Component B KnitCuff Component CVelcro/Component DSewing thread SMS	Level 4 Standard Surgical Gown:SMS nonwoven, PE film,Polyester and blue masterbatch;Level 4 Reinforced SurgicalGown: SMS nonwoven Polyester,PE film reinforced film and Bluemasterbatch	Similar
Weight persquare	$60 g/m^2$	$65 g/m^2$	Similar
Label andLabeling	Conforms with 21 CFR Part801	Conforms with 21 CFR Part 801	Same
Size	M, L, XL, and XXL	S, M, L, XL, XXL, and XXXL	Similar
Break Strength(ASTM D 5034-09)	>30 N	>30 N	Same
Tear Strength(ASTM D5587-14)	>20 N	>20 N	Same
Seam Strength(ASTM D1683-17)	>50 N	>50 N	Same
Linting (ISO 9073-10:2003)	Log10 < 4	Log10 < 4	Same
Flammability (16 CFR 1610)	Class I	Class I	Same
Hydrostatic pressure (AATCC 127)	>50 cm	>50 cm	Same
Water impact(AATC TestMethod 42)	≤1.0 g	≤1.0 g	Same
Barrier Penetration(ASTM F1671)	No detectable transfer of the Phi-X174 Bacteriophage	No detectable transfer of the Phi-X174 Bacteriophage	Same
Barrier Protection Level	Level 4 per AAMI PB 70	Level 4 per AAMI PB 70	Same
Water Vapor Transmission(ASTM D6701)	Average transmission/per-meation rate 4.360 g/m² day	Unknown	Unknown
Elements of Comparison	Proposed Device	Predicate Device	Remark
Biocompatibility
Cytotoxicity (ISO 10993-5)	No Cytotoxicity	No Cytotoxicity	Same
Skin Irritation (ISO 10993-10)	No Irritation	No Irritation	Same
Sensitization (ISO 10993, 10993-1, and 10993-10)	No Sensitization	No Sensitization	Same
Sterile	Ethylene Oxide (EO),SAL=10-6 Sterile	Ethylene Oxide (EO), SAL=10-6Sterile	Same

Table 2 Technological Characteristic Comparison

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Summary of Non-Clinical Test:

Non-Clinical Tests:

The product was tested in alignment with "Guidance on Premarket Notification 510(k) Submissions for Surgical Gowns and Surgical" Guidance Document

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Table 3:
Test Method	Purpose	Acceptance Criteria	Results
AATCC 127	Water resistanceHydrostaticPressure	>50 cm H2O (AQL4%, RQL=20%)	All test samples were> 50 cm H2O
AATCC 42	Water Resistanceimpactpenetration	<1.0 g penetration(AQL 4%, RQL=20%)	All test samples were< 1 g penetration
ASTM D5034-09	BreakingStrength	>30 N (AQL 4%,RQL=20%)	All test samples were>30N
ASTM D5587-14	Tearing Strength	>20 N (AQL 4%,RQL=20%)	All test samples were>20 N
16 CFR 1610	Flammabilitytesting	Class I	Meets Class I
ASTM D1683-17	Seam Strength	>50 N (AQL 4%,RQL=20%)	All test samples were>50 N
D6701-16	Water vaportransmission ofNonwoven andplastic Barriers	>500 g/m² DayWVTR	Passed
ASTMD3776/D	Mass Per Area(Weight) of fab-ric	Has met acceptancecriteria according toASTM F2407	Has met acceptancecriteria according toASTM F2407
ASTM F1670	Resistance bysynthetic Blood	No Penetration at 2psi (13.8 kPA)	Passed
ASTM F1671	Resistance ofMaterials Used inProtective Cloth-ing to Penetra-tion byBlood-BornePathogens	No detectable trans-fer of the Phi-X174Bacteriophage	Passed
ISO 9073-10:2003	Lint and Otherparticles genera-tion in the drystate	Log 10<4	Below Log10<4Passed
ASTM D4169-16	Performancetesting of ship-ping containersand systems	Products must with-stand the distribu-tion environment	Passed

ASTM F88-07A	Seal strength ofFlexible BarrierMaterials	Package Seal in-tegrity must be in-tact.	Passed
ASTM F2096-04	Detecting GrossLeaks in medicalpackaging by in-ternal pressuriza-tion (Bubble test)	Package integritymust be intact with-out failed seal loca-tions.	Passed
ASTM F1980-07	Accelerated Ag-ing of Sterile Bar-rier Systems formedical devices	Package integritymust be intact afteraccelerated aging	Passed
ISO 10993-5	Biological Evalua-tion of medicaldevices - Part 5:tests for In vitrocytotoxicity ofmedical devices	Device must not becytotoxic	Under the conditionof the testing, the de-vice is non-cytotoxic
ISO 10993-10	Biological Evalua-tion of medicaldevices - Part10: Tests for irri-tation and skinsensitization / Ir-ritation	Device must not beirritant	Under the conditionof the testing, the de-vice is not an irritant
ISO 10993-10	Biological Evalua-tion of medicaldevices - Part10: Tests for irri-tation and skinsensitization/sensitization	Device must not besensitizer	Under the conditionof the testing, the de-vice is not a sensitizer
ISO 10993-7	Biological Evalua-tion of medicaldevices- Part 7:Ethylene OxideSterilizationResiduals	Residual Ethyleneoxide levels must bebelow limits EO <4mg/device. The de-vice met require-ments of ISO 1099-7:2008	Ethylene Oxide resid-ual levels are belowlimitations. Data notavailable, required tomeet the require-ments of ISO 10993-7:2008

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Summary of Clinical Tests:

No clinical tests were performed.

Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the device Bodygard SFS Surgical Gown Level 4 is as safe, as effective, and performs as well as or better than the legally marketed predicate device Disposable Surgical Gown, Disposable Reinforced Surgical Gown.

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.