Surgical Gown

K213844 · Bayteks Teknik Tekstil San. VE Tic. A.S. · FYA · Feb 16, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K213844
• Device Name: Surgical Gown
• Applicant: Bayteks Teknik Tekstil San. VE Tic. A.S.
• Product Code: FYA · General, Plastic Surgery
• Decision Date: Feb 16, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

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.

Device Story

Surgical gown; single-use, disposable protective apparel. Constructed of Spunbond (SMS) nonwoven polypropylene with polyester/elastic cuffs. Available in six sizes (S-XXXL) and two configurations: standard (non-reinforced, Level 2) and reinforced (Level 3). Ethylene oxide (EO) sterilized. Worn by operating room personnel during surgical procedures to provide a barrier against microorganisms, body fluids, and particulate material. Protects both patient and healthcare professional. No electronic components or software.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Materials: SMS Polypropylene nonwoven, polyester/elastic cuffs. Barrier performance: ANSI/AAMI PB70:2012 (Level 2 standard, Level 3 reinforced). Sterilization: Ethylene Oxide. Standards: AATCC 127 (hydrostatic pressure), AATCC 42 (impact penetration), ASTM F 2407/D 5034 (tensile), ASTM D 5587 (tear), ASTM D 1683 (seam), 16 CFR 1610 (flammability), ISO 9073-10 (linting), ISO 10993 (biocompatibility).

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.

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

• Surgical Gown (K202706)

Reference Devices

• Medline Surgical Gown (K190950)

Submission Summary (Full Text)

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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.

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

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### Indications for Use

510(k) Number (if known) K213844

Device Name Surgical Gown

Indications for Use (Describe)

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.

| 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)

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## 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: [phone] Fax: [phone] [e-mail]

#### 2. Submission Correspondent

Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 Office Phone: [phone] Email: [e-mail] 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

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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

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.

#### 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 Gown<br>K213844 | Predicate Gown<br>K202706 | Reference Device<br>K190950 | Comparison |
|----------------------|------------------------------------------------------------------|------------------------------------------------------------------------------|---------------------------------------------------------|------------|
| Product Code | FYA | FYA | FYA | Same |
| Regulation<br>Number | 878.4040 | 878.4040 | 878.4040 | Same |
| Class | II | II | II | Same |
| Intended Use | To protect both patients<br>and healthcare<br>personnel from the | To protect both patients<br>and healthcare personnel<br>from the transfer of | To protect both<br>patients and<br>healthcare personnel | Same |

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

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| Attribute | Subject Gown<br>K213844 | Predicate Gown<br>K202706 | Reference Device<br>K190950 | Comparison |
|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| | transfer of<br>microorganisms, body<br>fluids, and particulate<br>material. | microorganisms, body<br>fluids, and particulate<br>material. | from the transfer of<br>microorganisms,<br>body fluids, and<br>particulate material. | |
| Indication for<br>Use | Surgical gowns are<br>intended to be worn by<br>operating room<br>personnel during<br>surgical procedures to<br>protect both the<br>surgical patient and the<br>operating room<br>personnel from transfer<br>of microorganisms,<br>body fluids, and<br>particulate material.<br>This device is provided<br>sterile. Per ANSI/AAMI<br>PB70:2012 Liquid<br>barrier performance<br>and classification of<br>protective apparel and<br>drapes intended for use<br>in health care facilities,<br>the standard (non-<br>reinforced) surgical<br>gowns meet Level 2<br>classification and the<br>reinforced surgical<br>gowns meet Level 3<br>classification. | Surgical gowns are<br>intended to be worn by<br>operating room<br>personnel during surgical<br>procedure to protect<br>both the surgical patient<br>and the operating room<br>personnel from transfer<br>of microorganisms, body<br>fluids, and particulate<br>material.<br>Per ANSI/AAMI<br>PB70:2012 Liquid barrier<br>performance and<br>classification of<br>protective apparel and<br>drapes intended for use<br>in health care facilities,<br>the surgical gowns meet<br>the requirements for<br>Level 3 classification. | The [multiple named<br>gowns] are sterile, single<br>use surgical apparel<br>intended to be worn by<br>healthcare professionals<br>to help protect both the<br>patient and the<br>healthcare worker from<br>the transfer of<br>microorganisms, body<br>fluids, and particulate<br>matter.<br>The [gowns] meet the<br>respective level<br>requirements of<br>ANSI/AAMI PB70:2012<br>Liquid barrier<br>performance and<br>classification of<br>protective apparel and<br>drapes intended for use<br>in healthcare facilities.<br>The [gowns] have been<br>validated using an<br>ethylene oxide (EtO)<br>sterilization process. The<br>[gowns] are also sold as<br>bulk single use, non-<br>sterile, to<br>repackager/relabeler<br>establishments for<br>further packaging and<br>sterilization using the<br>validated EtO<br>sterilization method<br>according to ISO 11135-1<br>prior to being provided<br>to the end user. | Similar |
| Prescription or<br>OTC | OTC | OTC | OTC | Same |
| Barrier Level<br>(per<br>ANSI/AAMI<br>PB70) | Standard: Level 2<br>Reinforced: Level 3 | Level 3 | Standard: Level 2<br>Reinforced: Level 3 | Similar |
| Attribute | Subject Gown<br>K213844 | Predicate Gown<br>K202706 | Reference Device<br>K190950 | Comparison |
| Device Materials | SMS Polypropylene<br>nonwoven, Polyester | SMS Polypropylene<br>nonwoven, Polyester | SMS Polypropylene<br>nonwoven, Polyester | Same |
| Device Design | Standard<br>(nonreinforced) &<br>Reinforced | Standard (nonreinforced) | Standard (nonreinforced)<br>& Reinforced | Similar |
| Durability | Single-Use (Disposable) | Single-Use (Disposable) | Single-Use (Disposable) | Same |
| Sizes | Small (S), Medium (M),<br>Large (L), Extra Large<br>(XL), Extra Extra Large<br>(XXL), Extra Extra Extra<br>Large (XXXL) | Small (S), Medium (M),<br>Large (L), Extra Large<br>(XL), Extra Extra Large<br>(XXL), Extra Extra Extra<br>Large (XXXL) | Small (S), Medium (M),<br>Large (L), Extra Large<br>(XL), Extra Extra Large<br>(XXL), Extra Extra Extra<br>Large (XXXL) | Same |
| Color | Blue | Blue | Blue | Same |
| Flammability<br>16 CFR Part 1610 | Class I | Class I | Class I | Same |
| Hydrostatic<br>Pressure<br>AATCC 127 | Level 2 > 20 cm<br>Level 3 > 50 cm | > 50 cm | - | Similar |
| Impact<br>Penetration<br>AATCC 42 | <1.0 g water | <1.0 g water | - | Same |
| Tear Strength<br>ASTM D 5587<br>(Trapezoid<br>Procedure) | Length Direction > 20 N<br>Width Direction > 20 N | > 20 N | - | Same |
| Tensile<br>Strength<br>ASTM F 2407<br>(ASTM D 5034) | Length Direction ≥ 115N<br>Width Direction ≥ 115N | > 20 N | - | Same |
| Seam Strength<br>ASTM D1683 | ≥ 20 N | > 20 N | - | Same |
| Linting<br>ISO 9073-10 | Log10 <4 | Log10 <4 | - | Same |
| Sterilization<br>Method | Ethylene Oxide | Ethylene Oxide Sterilized<br>and Non-Sterile Versions | - | Similar |
| EO and ECH<br>Residuals | EO: not detected<br>ECH: not detected | Passed | - | Same |
| Biocompatibility<br>Cytotoxicity<br>ISO 10993-5 | Non-cytotoxic | Non-cytotoxic | - | Same |
| Attribute | Subject Gown<br>K213844 | Predicate Gown<br>K202706 | Reference Device<br>K190950 | Comparison |
| Biocompatibility<br>Irritation<br>ISO 10993-10 | Non-irritating | Non-irritating | - | Same |
| Biocompatibility<br>Sensitization<br>10993-10 | Non-sensitizing | Non-sensitizing | - | Same |

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#### 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 | Acceptance<br>Criteria | Res<br>ult |
|------------------------------|--------------------------------------------|---------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| AATCC 127 | Hydrostatic pressure | Level 2 > 20 cm<br>Level 3 > 50 cm | Pass |
| AATCC 42 | Impact penetration | ≤1g | Pass |
| ASTM F 2407<br>(ASTM D 5034) | Tensile Strength | Length Direction ≥ 115N<br>Width Direction ≥ 115N | Pass |
| ASTM D 5587 | Tearing strength by<br>Trapezoid Procedure | Length Direction > 20 N<br>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<br>ECH 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 the<br>study, the proposed device extract was<br>determined to be non-cytotoxic |
| | Irritation | ISO 10993-10:2010 | ISO 10993-10; Under the conditions of the<br>study, the proposed device extract was<br>determined to be non-irritating |
| | Sensitization | ISO 10993-10:2010 | ISO 10993-10; Under the conditions of the<br>study, the proposed device extract was<br>determined to be non-sensitizing |

#### Table 2 – Summary of Performance Testing

#### 10. Clinical Performance Data

No clinical study is included in this submission.

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#### 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.