K Number
K202845
Device Name
Bodygard SFS Surgical Gown Level 3
Date Cleared
2022-02-24

(517 days)

Product Code
Regulation Number
878.4040
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Bodygard SFS Surgical Gown Level 3 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 3 met the requirements for Level 3 classification.
Device Description
The Bodygard SFS Surgical Gown Level 3 is a poly reinforced surgical gown, SMS Nonwoven/Film/SMS Nonwoven (SFS) that provides AAMI Level 3 liquid barrier protection in the critical zones (arms and chest) and non-critical zones of the gown. The Bodygard SFS Surgical Gown Level 3 is manufactured using ultrasonic bonding technique and are available in 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 3, meets the requirements for Level 3 classification, are disposable medical devices and provided in sterile.
More Information

Not Found

No
The device is a surgical gown, and the description focuses on its material properties and barrier performance, with no mention of AI or ML.

No
Explanation: A therapeutic device is designed to treat or alleviate a medical condition. This device, a surgical gown, is intended for protection and containment of microorganisms, not for therapeutic purposes.

No

Explanation: The device is a surgical gown intended to protect personnel and patients from the transfer of microorganisms, body fluids, and particulate material. It does not perform any diagnostic function.

No

The device is a physical surgical gown made of poly reinforced material, not software. The description details material composition, manufacturing techniques, and physical performance testing.

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

Here's why:

  • IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. These tests are performed outside the body.
  • Device Intended Use: The intended use of the Bodygard SFS Surgical Gown Level 3 is to protect operating room personnel and patients from the transfer of microorganisms, body fluids, and particulate material during surgical procedures. This is a barrier function, not a diagnostic test performed on a sample.
  • Device Description: The description focuses on the physical properties of the gown (material, construction, barrier performance) and its classification based on liquid barrier standards. It does not mention any components or functions related to analyzing biological samples.
  • Performance Studies: The performance studies listed are related to the physical and biological safety of the gown as a barrier (water resistance, strength, flammability, biocompatibility, sterilization). There are no studies related to the accuracy or performance of a diagnostic test.

In summary, the Bodygard SFS Surgical Gown Level 3 is a protective medical device used during a medical procedure, not a device used to perform diagnostic tests on biological samples.

N/A

Intended Use / Indications for Use

The Bodygard SFS Surgical Gown Level 3 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 3 met the requirements for Level 3 classification.

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

FYA

Device Description

The Bodygard SFS Surgical Gown Level 3 is a poly reinforced surgical gown, SMS Nonwoven/Film/SMS Nonwoven (SFS) that provides AAMI Level 3 liquid barrier protection in the critical zones (arms and chest) and non-critical zones of the gown. The Bodygard SFS Surgical Gown Level 3 is manufactured using ultrasonic bonding technique and are available in 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 3, meets the requirements for Level 3 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 / operating room

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 included:

  • Water resistance Hydrostatic Pressure (AATCC 127): All were > 50cmH2O.
  • Water Resistance impact penetration (AATCC 42): All were 30N.
  • Tearing Strength (ASTM D5587- 14): All were >20 N.
  • Flammability testing (16 CFR 1610): Meets Class I.
  • Seam Strength (ASTM D4169- 16): All were >50 N.
  • Water vapor transmission of Nonwoven and plastic Barriers (D6701-16): Passed.
  • Mass Per Area (Weight) of fabric (ASTM D3776/D): Has met acceptance criteria.
  • Resistance by synthetic Blood (ASTM F1670): Passed.
  • Lint and Other particles generation in the dry state (ISO 9073- 10:2003): Below Log10

§ 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.

0

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 & 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.

February 24, 2022

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

Re: K202845

Trade/Device Name: Bodygard SFS Surgical Gown Level 3 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYA Dated: February 8, 2022 Received: February 8, 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.

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

1

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,

Clarence W. Murray III, PhD 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

Enclosure

2

Indications for Use

510(k) Number (if known) K202845

Device Name BodyGard SFS Surgical Gown Level 3

Indications for Use (Describe)

The Bodygard SFS Surgical Gown Level 3 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 3 met the requirements for Level 3 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)

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-K202845 Traditional 510(k)

In accordance with 21 CFR §807.92 and the following information is provided for the Bodygard SFS Surgical Gown Level 3 510(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 LTD Sti
Eskishir Organize Sanayi Bolgesi 26. Cad No. 9 26110
Eskisehir |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person/
Prepared by: | Darren Reeves
President
DP Distribution & Consulting, LLC
(804) 307-7706
dreeves@dpdconline.com
7305 Hancock Village Drive
Suite 109
Chesterfield, Virginia 23832 |
| Date: | 02/17/2022 |
| Subject Device: | Trade Name: Bodygard SFS Surgical Gown Level 3
Common Name: Surgical Gown
Classification Name: Surgical Gown (21 CFR 878.4040
Product Code FYA) |
| Predicate Device: | Medical Surgical Gowns (K202844) |

Purpose and Device Description:

The Bodygard SFS Surgical Gown Level 3 is a poly reinforced surgical gown, SMS Nonwoven/Film/SMS Nonwoven (SFS) that provides AAMI Level 3 liquid barrier protection in the critical zones (arms and chest) and non-critical zones of the gown. The Bodygard SFS Surgical Gown Level 3 is manufactured using ultrasonic bonding technique and are available in 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

4

Bodygard SFS Surgical Gown Level 3, meets the requirements for Level 3 classification, are disposable medical devices and provided in sterile.

Intended Use and Indication for Use:

The Bodygard SFS Surgical Gown Level 3 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 3 met the requirements for Level 3 classification.

Technological Characteristic Comparison of Predicate Device:

| Elements of
Comparison | Proposed Device
K202845 | Predicate Device
K202844 | Comparison |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | Bodygard SFS Surgical
Gown Level 3 | Medical Surgical Gowns | |
| 510 (k)
Number | K202845 | K202844 | N/A |
| Product Code | FYA | FYA | Same |
| Regulation
Number | 878.4040 | 878.4040 | Same |
| Indication for Use | The Bodygard SFS
Surgical Gown Level 3 is
a poly reinforced
surgical gown, SMS
Nonwoven/Film/SMS
Nonwoven (SFS) that
provides AAMI Level 3
liquid barrier protection
in the critical zones
(arms and chest) and
non-critical zones of the
gown. The Bodygard SFS
Surgical Gown Level 3 is
manufactured using
ultrasonic
bonding technique | The Medical Surgical
Gowns is intended to be
worn by operating room
personnel during surgical
procedure to protect
both the surgical patient
and the operating room
personnel from trans- fer
of microorganisms, body
fluids, and particulate
material.
Per ANSI/AAMI
PB70:2012
Liquid barrier
performance and | Similar |
| | and are available in
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 3,
meets the requirements
for Level 3 classification,
are disposable medical
devices and provided in
sterile. | classification of
protective apparel
and drapes intended
for use in
health care facilities,
the Medical
Surgical Gowns met the
requirements for Level
3 classification. | |
| Style | Poly Reinforced | Poly reinforced | Same |
| Durability | Disposable | Disposable | Same |
| Color | Blue | Blue | Same |
| Material | Spundbond SMS
polypropylene,
polyester, PP Velcro | SMS Nonwoven,
polyethylene | Similar |
| Weight per
quote | 60 g/m2 | 55 g/m2 | Similar |
| Size | M, L, XL, and XXL | S, M, L, XL, XXL, XXXL | Similar |
| Break Strength | >30N | >20N | Similar |
| Tear Strength | >20N | >20N | Similar |
| Seam Strength | > 50 N | Not known | Similar |
| lint | Log1050cm | >50cm | Same |
| Water impact | ≤1.0 g | ≤1.0 g | Same |
| Level | Level 3 Per AAMI PB70 | Level 3 per AAMI PB70 | Same |
| Water Vapor Transmission | Average
transmission/permeatio n
rate 4.360 gm/m2 day | Unknown | Unknown |
| Elements of Comparison | Proposed Device | Predicate Device | Remark |
| Biocompatibility | | | |
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity | Same |
| Skin Irritation | No Irritation | No Irritation | Same |
| Sensitization | No Sensitization | No Sensitization | Same |
| Sterile | Ethylene Oxide (EO),
SAL=10-6 | Ethylene Oxide (EO),
SAL=10-6 | Same |

Table 1 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

Test MethodPurposeAcceptance CriteriaResults
AATCC 127Water resistance
Hydrostatic Pressure>50cmH2O (AQL 4%,
RQL=20%)All were > 50cmH2O
AATCC 42Water Resistance impact
penetration30 N (AQL 4%,
RQL=20%)All were >30N
ASTM D5587- 14Tearing Strength>20 N (AQL 4%,
RQL=20%)All were >20 N
16 CFR 1610Flammability
testingClass IMeets Class I
ASTM D4169- 16Seam Strength>50 N (AQL 4%,
RQL=20%)All were>50 N
D6701-16Water vapor
transmission of>500gram/m2 Day
WVTRPassed
Nonwoven and
plastic Barriers
ASTM D3776/DMass Per Area (Weight)
of fabric-Has met acceptance
criteria
ASTM F1670Resistance by synthetic
BloodNo Penetration at 2 psi
(13.8 kPA)Passed
ISO 9073-
10:2003Lint and Other particles
generation in the dry
stateLog 10