Bodygard SFS Surgical Gown Level 4

K221139 · Feliks Plastik Laminasyon VE Ambalaj Malzemeleri · FYA · Nov 10, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K221139
• Device Name: Bodygard SFS Surgical Gown Level 4
• Applicant: Feliks Plastik Laminasyon VE Ambalaj Malzemeleri
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Nov 10, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended 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.

Device Story

Bodygard SFS Surgical Gown Level 4 is a single-use, poly-reinforced surgical gown; constructed from SMS nonwoven/film/SMS nonwoven (SFS) material; manufactured via ultrasonic bonding. Provides AAMI Level 4 liquid barrier protection in critical (arms/chest) and non-critical zones. Used in operating rooms by surgical personnel to prevent cross-contamination of microorganisms, body fluids, and particulates between patient and staff. Supplied sterile via Ethylene Oxide (EO).

Clinical Evidence

No clinical data. Bench testing only. Performance verified via AATCC 127 (hydrostatic pressure), AATCC 42 (water impact), ASTM D5034-09 (breaking strength), ASTM D5587-14 (tear strength), ASTM D1683-17 (seam strength), ASTM F1671 (viral penetration), and ISO 10993 series (biocompatibility/cytotoxicity/irritation/sensitization).

Technological Characteristics

Material: SMS nonwoven/film/SMS nonwoven (SFS). Construction: Ultrasonic bonding. Barrier: AAMI Level 4 per ANSI/AAMI PB70:2012. Sterilization: Ethylene Oxide (EO), SAL 10^-6. Standards: ASTM D5034-09, D5587-14, D1683-17, F1670, F1671, ISO 9073-10, 10993-5/7/10, 16 CFR 1610.

Indications for Use

Indicated for operating room personnel during surgical procedures to protect patient and personnel from transfer of microorganisms, body fluids, and particulate material. No specific age or gender restrictions.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Disposable Surgical Gown, Disposable Reinforced Surgical Gown (K212869)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 [phone]

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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.<br>Eskishir Organize Sanayi Bolgesi 26. Cad No. 9 26110<br>Eskisehir |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Ali Serdar Serteser<br>[e-mail]<br>[phone]<br>Eskisehir Industrial Zone 26st No 9<br>Odunpazari, Eskisehir Turkey |
| Contact Person/<br>Prepared by: | Darren Reeves<br>President<br>DP Distribution & Consulting, LLC ®<br>[phone]<br>[e-mail]<br>12240 Hunting Horn Lane<br>Rockville, Virginia 23146 |
| Preparation Date: | 11/08/2022 |
| Subject Device: | Trade Name: Bodygard SFS Surgical Gown Level 4<br>510(k) #: K221139<br>Common Name: Surgical Gown<br>Classification Name: Surgical Gown (21 CFR 878.4040,<br>Product Code FYA) |
| Predicate Device: | Disposable Surgical Gown, Disposable Reinforced Surgical<br>Gown (K212869) |

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### 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<br>Comparison | Proposed Device<br>Bodygard SFS Surgical<br>Gown Level 4 | Predicate Device K212869<br>Disposable Surgical Gown,<br>Disposable Reinforced Surgical<br>Gown (Sterile) | Remark |
|--------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| 510 (k) Number | K221139 | K212869 | N/A |
| Product Code | FYA | FYA | Same |
| Regulation<br>Number | 21CFR 878.4040 | 21CFR 878.4040 | Same |
| Indication for Use | | | |
| | The Bodygard SFS Surgical<br>Gown Level 4 is intended<br>to be worn by operating<br>room personnel during<br>surgical procedure to pro-<br>tect both the surgical pa-<br>tient and the operating<br>room personnel from<br>transfer of microorgan-<br>isms, body fluids,<br>and particulate material.<br><br>Per ANSI/AAMI PB70:2012<br>Liquid barrier performance<br>and classification of pro-<br>tective apparel and drapes<br>intended for use in health<br>care facilities, Bodygard<br>SFS Surgical Gown Level 4<br>met the requirements for<br>Level 4 classification. | Disposable Surgical Gown and<br>Disposable Reinforced Surgical<br>Gown are intended to be worn by<br>operating room personnel during<br>surgical procedure to protect<br>both the surgical patient and the<br>operating room personnel from<br>transfer of microorganisms, body<br>fluids, and particulate material.<br><br>Per ANSI/AAMI PB70:2012 Liquid<br>barrier performance and classifi-<br>cation of protective apparel and<br>drapes intended for use in health<br>care facilities, Disposable Surgical<br>Gown ML515M45U met the re-<br>quirements for Level 3 classifica-<br>tion, Disposable Surgical Gown<br>GD524ME65 and Disposable Re-<br>inforced Surgical Gown met the<br>requirements of Level 4 classifi-<br>cation. | Similar |
| Style | Poly Reinforced | Non-reinforced/Reinforced | Similar |
| Durability | Disposable | Disposable | Same |
| Color | Blue | Blue | Same |
| Material | Complete gown has 4 com-<br>ponents/Component A<br>Fabric SMS Nonwoven/<br>Lamination Reinforcement<br>Film/SMS Nonwoven<br>(SFS)/Component B Knit<br>Cuff Component C<br>Velcro/Component D<br>Sewing thread SMS | Level 4 Standard Surgical Gown:<br>SMS nonwoven, PE film,<br>Polyester and blue masterbatch;<br>Level 4 Reinforced Surgical<br>Gown: SMS nonwoven Polyester,<br>PE film reinforced film and Blue<br>masterbatch | Similar |
| Weight per<br>square | $60 g/m^2$ | $65 g/m^2$ | Similar |
| Label and<br>Labeling | Conforms with 21 CFR Part<br>801 | Conforms with 21 CFR Part 801 | Same |
| Size | M, L, XL, and XXL | S, M, L, XL, XXL, and XXXL | Similar |
| Break Strength<br>(ASTM D 5034-<br>09) | >30 N | >30 N | Same |
| Tear Strength<br>(ASTM D5587-14) | >20 N | >20 N | Same |
| Seam Strength<br>(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<br>(AATC Test<br>Method 42) | ≤1.0 g | ≤1.0 g | Same |
| Barrier Penetration<br>(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<br>(ASTM D6701) | Average transmission/per-<br>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),<br>SAL=10-6 Sterile | Ethylene Oxide (EO), SAL=10-6<br>Sterile | 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 resistance<br>Hydrostatic<br>Pressure | >50 cm H2O (AQL<br>4%, RQL=20%) | All test samples were<br>> 50 cm H2O |
| AATCC 42 | Water Resistance<br>impact<br>penetration | <1.0 g penetration<br>(AQL 4%, RQL=20%) | All test samples were<br>< 1 g penetration |
| ASTM D<br>5034-09 | Breaking<br>Strength | >30 N (AQL 4%,<br>RQL=20%) | All test samples were<br>>30N |
| ASTM D5587-<br>14 | Tearing Strength | >20 N (AQL 4%,<br>RQL=20%) | All test samples were<br>>20 N |
| 16 CFR 1610 | Flammability<br>testing | Class I | Meets Class I |
| ASTM D1683-<br>17 | Seam Strength | >50 N (AQL 4%,<br>RQL=20%) | All test samples were<br>>50 N |
| D6701-16 | Water vapor<br>transmission of<br>Nonwoven and<br>plastic Barriers | >500 g/m² Day<br>WVTR | Passed |
| ASTM<br>D3776/D | Mass Per Area<br>(Weight) of fab-<br>ric | Has met acceptance<br>criteria according to<br>ASTM F2407 | Has met acceptance<br>criteria according to<br>ASTM F2407 |
| ASTM F1670 | Resistance by<br>synthetic Blood | No Penetration at 2<br>psi (13.8 kPA) | Passed |
| ASTM F1671 | Resistance of<br>Materials Used in<br>Protective Cloth-<br>ing to Penetra-<br>tion by<br>Blood-Borne<br>Pathogens | No detectable trans-<br>fer of the Phi-X174<br>Bacteriophage | Passed |
| ISO 9073-<br>10:2003 | Lint and Other<br>particles genera-<br>tion in the dry<br>state | Log 10<4 | Below Log10<4<br>Passed |
| ASTM D4169-<br>16 | Performance<br>testing of ship-<br>ping containers<br>and systems | Products must with-<br>stand the distribu-<br>tion environment | Passed |
| | | | |
| ASTM F88-<br>07A | Seal strength of<br>Flexible Barrier<br>Materials | Package Seal in-<br>tegrity must be in-<br>tact. | Passed |
| ASTM F2096-<br>04 | Detecting Gross<br>Leaks in medical<br>packaging by in-<br>ternal pressuriza-<br>tion (Bubble test) | Package integrity<br>must be intact with-<br>out failed seal loca-<br>tions. | Passed |
| ASTM F1980-<br>07 | Accelerated Ag-<br>ing of Sterile Bar-<br>rier Systems for<br>medical devices | Package integrity<br>must be intact after<br>accelerated aging | Passed |
| ISO 10993-5 | Biological Evalua-<br>tion of medical<br>devices - Part 5:<br>tests for In vitro<br>cytotoxicity of<br>medical devices | Device must not be<br>cytotoxic | Under the condition<br>of the testing, the de-<br>vice is non-cytotoxic |
| ISO 10993-10 | Biological Evalua-<br>tion of medical<br>devices - Part<br>10: Tests for irri-<br>tation and skin<br>sensitization / Ir-<br>ritation | Device must not be<br>irritant | Under the condition<br>of the testing, the de-<br>vice is not an irritant |
| ISO 10993-10 | Biological Evalua-<br>tion of medical<br>devices - Part<br>10: Tests for irri-<br>tation and skin<br>sensitization/<br>sensitization | Device must not be<br>sensitizer | Under the condition<br>of the testing, the de-<br>vice is not a sensitizer |
| ISO 10993-7 | Biological Evalua-<br>tion of medical<br>devices- Part 7:<br>Ethylene Oxide<br>Sterilization<br>Residuals | Residual Ethylene<br>oxide levels must be<br>below limits EO <4<br>mg/device. The de-<br>vice met require-<br>ments of ISO 1099-<br>7:2008 | Ethylene Oxide resid-<br>ual levels are below<br>limitations. Data not<br>available, required to<br>meet the require-<br>ments of ISO 10993-<br>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.