Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a surgical gown and its physical and barrier properties. There is no mention of AI or ML in the intended use, device description, or performance studies.

Therapeutic

No
The device is a surgical gown designed to protect operating room personnel and patients from contamination, not to treat a medical condition or disease.

Diagnostic

No

Explanation: The device is a surgical gown intended for protection during surgical procedures, not for diagnosing any condition or disease. Its performance is evaluated based on barrier properties and physical strength, not diagnostic accuracy.

SaMD (Software as a Medical Device)

No

The device is a physical surgical gown, not a software application. The description focuses on material properties and barrier performance.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the gown is for protecting surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic function.
Device Description: The description focuses on the physical properties of the gown (material, construction, barrier level) and its classification based on liquid barrier performance.
Performance Studies: The performance studies described are non-clinical tests evaluating the physical and barrier properties of the gown (water resistance, strength, flammability, etc.). There are no studies related to analyzing biological samples or diagnosing conditions.
Key Metrics: The key metrics are not diagnostic metrics like sensitivity, specificity, or AUC. They are related to the physical performance of the gown.
Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing information for diagnosis, monitoring, or treatment decisions based on the analysis of such samples.

An IVD is a medical device intended for use in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring, or compatibility purposes. This surgical gown does not fit that definition. It is a protective barrier device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

FYA

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

operating room personnel

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Tests:
The product was tested in alignment with "Guidance on Premarket Notification 510(k) Submissions for Surgical Gowns and Surgical" Guidance Document.
Key Results:

AATCC 127 (Water resistance Hydrostatic Pressure): All test samples were > 50 cm H2O.
AATCC 42 (Water Resistance impact penetration): All test samples were 30N.
ASTM D5587- 14 (Tearing Strength): All test samples were >20 N.
16 CFR 1610 (Flammability testing): Meets Class I.
ASTM D1683- 17 (Seam Strength): All test samples were >50 N.
D6701-16 (Water vapor transmission of Nonwoven and plastic Barriers): Passed.
ASTM D3776/D (Mass Per Area (Weight) of fabric): Has met acceptance criteria according to ASTM F2407.
ASTM F1670 (Resistance by synthetic Blood): Passed.
ASTM F1671 (Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens): Passed.
ISO 9073- 10:2003 (Lint and Other particles generation in the dry state): Below Log10

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.

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.

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 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)

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.

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

FF

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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 26110
Eskisehir |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Ali Serdar Serteser
Felix@felixplastic.com
+90 533 209 72 95
Eskisehir Industrial Zone 26st No 9
Odunpazari, Eskisehir Turkey |
| Contact Person/
Prepared by: | Darren Reeves
President
DP Distribution & Consulting, LLC ®
(804) 307-7706
dreeves@dpdconline.com
12240 Hunting Horn Lane
Rockville, Virginia 23146 |
| Preparation Date: | 11/08/2022 |
| Subject Device: | Trade Name: Bodygard SFS Surgical Gown Level 4
510(k) #: K221139
Common Name: Surgical Gown
Classification Name: Surgical Gown (21 CFR 878.4040,
Product Code FYA) |
| Predicate Device: | Disposable Surgical Gown, Disposable Reinforced Surgical
Gown (K212869) |

4

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.

Intended Use and Indication for Use:

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.

Comparison of Predicate Device:

| Elements of
Comparison | Proposed Device
Bodygard SFS Surgical
Gown Level 4 | Predicate Device K212869
Disposable Surgical Gown,
Disposable Reinforced Surgical
Gown (Sterile) | Remark |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| 510 (k) Number | K221139 | K212869 | N/A |
| Product Code | FYA | FYA | Same |
| Regulation
Number | 21CFR 878.4040 | 21CFR 878.4040 | Same |
| Indication for Use | | | |
| | The Bodygard SFS Surgical
Gown Level 4 is intended
to be worn by operating
room personnel during
surgical procedure to pro-
tect both the surgical pa-
tient and the operating
room personnel from
transfer of microorgan-
isms, body fluids,
and particulate material.

Per ANSI/AAMI PB70:2012
Liquid barrier performance
and classification of pro-
tective apparel and drapes
intended for use in health
care facilities, Bodygard
SFS Surgical Gown Level 4
met the requirements for
Level 4 classification. | Disposable Surgical Gown and
Disposable Reinforced Surgical
Gown are 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.

Table 2 Technological Characteristic Comparison

5

6

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

7

Table 3:
Test Method	Purpose	Acceptance Criteria	Results
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 | 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 fab-
ric | 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 Cloth-
ing to Penetra-
tion by
Blood-Borne
Pathogens | No detectable trans-
fer of the Phi-X174
Bacteriophage | Passed |
| ISO 9073-
10:2003 | Lint and Other
particles genera-
tion in the dry
state | Log 10