Flosteril Poly-reinforced Isolation Gowns Model 8120 (Catalogue Number 8120400), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120410), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120430), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120450), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120460)

K210148 · Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti. · FYC · Apr 13, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K210148
• Device Name: Flosteril Poly-reinforced Isolation Gowns Model 8120 (Catalogue Number 8120400), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120410), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120430), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120450), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120460)
• Applicant: Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti.
• Product Code: FYC · General, Plastic Surgery
• Decision Date: Apr 13, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

Flosteril Poly-Reinforced Isolation Gowns, Model 8120 (Catalogue Numbers 8120400, 8120430, 8120450, 8120460) is intended to be worn by healthcare personnel to protect patients and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. Flosteril Poly-Reinforced Isolation Gowns meet the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70) It is a single use, disposable medical device provided non-sterile and not intended for use in operating rooms. The medical device will be available in 15 models in Large, X Large and XX Large sizes.

Device Story

Flosteril Poly-Reinforced Isolation Gowns are single-use, disposable protective apparel. Designed for healthcare personnel to provide AAMI Level 3 barrier protection against microorganisms, body fluids, and particulates. Available in various configurations including knitted cuffs, elastic bands, thumb loops, and different closure mechanisms (hook and loop, ties, sticky tabs). Provided non-sterile. Not intended for use in operating rooms. Worn by clinicians and staff in healthcare settings to reduce cross-contamination risk.

Clinical Evidence

Bench testing only. Device performance evaluated against ANSI/AAMI PB70:2012 standards for liquid barrier performance.

Technological Characteristics

Single-use, disposable isolation gown. Meets AAMI Level 3 barrier protection per ANSI/AAMI PB70:2012. Features include knitted cuffs, elastic bands, thumb loops, and various closure types (hook and loop, tie, sticky tab). Available in Large, X Large, and XX Large sizes. Provided non-sterile.

Indications for Use

Indicated for use by healthcare personnel to protect patients and personnel from transfer of microorganisms, body fluids, and particulate material. Not for use in operating rooms.

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.

Submission Summary (Full Text)

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April 13, 2022

Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti. % Jay Mansour Principal Mansour Consulting LLC 845 Aronson Lake Court Roswell, Georgia 30075

Re: K210148

Trade/Device Name: Flosteril Poly-reinforced Isolation Gowns Model 8120 (Catalogue Numbers 8120400, 8120410, 8120430, 8120450, 8120460) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FYC Dated: March 11, 2022 Received: March 15, 2022

Dear Jay Mansour:

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

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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,

For Clarence W. Murray III, 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

Enclosure

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## Indications for Use

510(k) Number (if known) K210148

Device Name

Flosteril Poly-Reinforced Isolation Gowns, Model 8120 (Catalogue Numbers 8120400, 8120450, 8120460)

## Indications for Use (Describe)

Flosteril Poly-Reinforced Isolation Gowns, Model 8120 (Catalogue Numbers 8120400, 8120430, 8120450, 8120460) is intended to be worn by healthcare personnel to protect patients and healthcare personnel from the transfer of microorganisms, body fluids and particulate material.

Flosteril Poly-Reinforced Isolation Gowns meet the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70)

It is a single use, disposable medical device provided non-sterile and not intended for use in operating rooms. The medical device will be available in 15 models in Large, X Large and XX Large sizes.

| Catalogue number | Specific attributes | REF (L; XL; XXL) |
|------------------|------------------------------------------------|---------------------------------|
| 8120400 | Hook and loop; Knitted cuff; collar lace; tag | FLS 10401; FLS 10402; FLS 10403 |
| 8120410 | Hook and loop; elastic band; collar lace; tag | FLS 10411; FLS 10412; FLS 1041 |
| 8120430 | Knitted cuff; tie; collar lace; tag | FLS 10431; FLS 10432; FLS 10432 |
| 8120450 | Elastic band; sticky tab; tag | FLS 10451; FLS 10452; FLS 10452 |
| 8120460 | Elastic band; thumb loop cuff; sticky tab; tag | FLS 10461; FLS 10462; FLS 10462 |

| 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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