Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical barrier properties and material composition of a surgical mask, with no mention of AI or ML.

Therapeutic

No.
A therapeutic device is used to treat or cure a disease or condition. This device is a mask for protection and infection control, not for treatment.

Diagnostic

No

The device is a surgical mask intended to protect against transfer of microorganisms and fluids, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical product made of various materials (polypropylene, elastic laminate, wire nosepiece) and intended for physical barrier protection. There is no mention of software components or functionality.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the mask is for protecting both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body) on biological samples.
Device Description: The description details the physical construction and materials of a surgical mask. There is no mention of reagents, assays, or any components used for analyzing biological samples.
Performance Studies: The performance studies focus on barrier properties (fluid resistance, filtration efficiency), flammability, physical properties (differential pressure), and biocompatibility. These are all relevant to the function of a physical barrier device, not an IVD.
Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There are no metrics related to diagnostic performance like sensitivity, specificity, or AUC in the context of identifying a disease or condition.

In summary, the Myflon Surgical Mask Level 3 is a medical device intended for physical protection, not for performing diagnostic tests on biological samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Myflon Surgical Mask Level 3 is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided non-sterile.

Product codes

FXX

Device Description

The Myflon Surgical Mask Level 3 is blue in color, composed of three-layers, a flat-pleated type mask, utilizing ear loops for wearing. The Myflon Surgical Mask Level 3 materials consist of an outer cover (polypropylene spunbond, blue), middle filtration layer (polypropylene, melt-blown, white), and inner cover comfort/support layer web (polypropylene spunbond, white). Each mask has stretchable elastic laminate (Spunbond/elastic film/spunbond bond) ear loops to secure the mask over the user's mouth and nose and includes a polyethylene/ polypropylene coated wire nosepiece to provide a firm fit over the face and nose. This face mask is a single use, disposable device, provided non-sterile. This device is not made with natural rubber latex.

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

Not Found

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)

The product was tested in alignment with "Guidance for Industry and o FDA Staff - Surgical Masks - Premarket Notification [510(k)] Submission" Guidance Document:

ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- O Part 5: Tests For In Vitro Cytotoxicity
ISO 10993-10: 2010 Biological Evaluation of Medical Devices Part O 10: Tests For Irritation And Skin Sensitization
ASTM F2100-19, Standard Specification for Performance Of O Materials Used In Medical Face Masks
ASTM F1862-17, Standard Test Method for Resistance of Medical O Face Masks to Penetration By Synthetic Blood (Horizontal Projection Of Fixed Volume At A Known Velocity)
EN 14683: European standard for face masks O
ASTM F2101-19, Standard Test Method for Evaluating The O Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using a Biological Aerosol Of Staphylococcus Aureus;
ASTM F2299-03, Stand test method for determining the initial O efficiency of materials used in medical face masks to penetration by particulates using latex spheres;
16 CFR 1610, Standard for the Flammability of clothing textiles. O

Key results from bench testing:

Barrier Testing - Fluid resistance: Passed at 160mmHg
Barrier Testing - Particle Filtration Efficiency: Passed >= 98%
Barrier Testing - Bacterial Filtration Efficiency: Passed >= 98%
Safety Testing - Flammability Class: Passed - Class I Non-Flammable (Acceptance Criteria: Class 1 (>= 3.5 seconds))
Physical Testing - Differential Pressure Delta-P: Passed

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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern. To the right of the seal, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" below. The logo is simple and professional, reflecting the FDA's role in regulating food and drugs.

January 23, 2022

Feliks Plastik Laminasyon Ve Ambalaj Malzemeleri Sanayi % W. Rogers Owner Rogers Consulting 11110 Arranmore Cove Roanoke, Indiana 46783

Re: K212111

Trade/Device Name: Myflon Surgical Mask Level 3 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: December 8, 2021 Received: December 13, 2021

Dear W. Rogers:

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 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, 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

Enclosure

2

Indications for Use

51 0(k) Number (if known) K212111

Device Name Myflon Surgical Mask Level 3

Indications for Use (Describe)

Myflon Surgical Mask Level 3 is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided non-sterile.

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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3

K212111 510(k) Summary

In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Myflon Surgical Mask 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 A.S.
Eskishir Organize Sanayi Bolgesi 26. Cad No. 9 26110
Eskisehir Turkey
Establishment Registration Number: 3017355692 |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ali Serdar Serteser
Manager
+90 533 209 72 95 |
| 510(k) Number: | K212111 |
| Designated Submission
Correspondent: | W. Victoria Rogers
Rogers Consulting
11110 Arranmore Cove
Roanoke, Indiana 46783
574-265-8356 |
| Date: | January 20, 2022 |
| Subject Device: | Myflon Surgical Mask Level 3 |
| Common Name: | Surgical Mask |
| Classification Name: | Surgical Mask |
| Product Code: | FXX |
| Regulation Number: | (21 CFR 878.4040) |
| Review Panel: | General & Plastic Surgery |
| Regulation Class: | Class II |
| Predicate Device: | Freudenberg Surgical Mask (K210063) |

4

Purpose and
Device Description:	The Myflon Surgical Mask Level 3 is blue in color, composed
of three-layers, a flat-pleated type mask, utilizing ear loops
for wearing. The Myflon Surgical Mask Level 3 materials
consist of an outer cover (polypropylene spunbond, blue),
middle filtration layer (polypropylene, melt-blown, white),
and inner cover comfort/support layer web (polypropylene
spunbond, white). Each mask has stretchable elastic laminate
(Spunbond/elastic film/spunbond bond) ear loops to secure the
mask over the user's mouth and nose and includes a
polyethylene/ polypropylene coated wire nosepiece to provide
a firm fit over the face and nose. This face mask is a single
use, disposable device, provided non-sterile. This device is not
made with natural rubber latex.
Intended Use and
Indication for Use:	Myflon Surgical Mask Level 3 is intended to be
worn to protect both the patient and healthcare
	personnel from transfer of microorganisms, body
	fluids and particulate material. This face mask is
intended for use in infection control practices
	to reduce the potential exposure to blood and
	body fluids. This is a single use, disposable
	device provided nonsterile.

Technological

Characteristics Comparison:

	Subject Device	Primary Predicate Device	Remark
	Myflon Surgical Mask
Level 3, K2112111	Freudenberg Surgical Mask
K210063
ASTM 2100
Level 3 Mask	3	3	Same
Intended Use/
Indications for
Use	Myflon Surgical Mask Level
3 is intended to be worn to
protect both the patient and
healthcare personnel from
transfer of microorganisms,
body fluids and particulate
material. This face mask is	The Freudenberg Surgical
Mask is intended to be
worn to protect both the
patient and healthcare
personnel from transfer of
microorganisms, body
fluids and particulate	Same

5

	intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided nonsterile.	material. This face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device provided nonsterile.
Outer Materials	Polypropylene spunbond, blue	Spun-bond polypropylene	Similar
Filter Media	Polypropylene, melt-blown, white	Melt blown polypropylene	Same
Inner Material	Polypropylene spunbond, white	Spun-bond polypropylene	Same
Nose Piece	Polyethylene/ polypropylene coated wire	Malleable polyethylene coated wire	Similar
Ear Loops	Spunbond/elastic film/spunbond bond	Polyester spandex blend	Similar
Specifications	Length: 175mm
Width: 95mm	Length: 175 mm +/- 1mm
Width: 95 mm +/- 1mm	Same
Mask Style	Flat-pleated	Flat-pleated	Same
Color	Blue	White	Different
Sterilization	Non-sterile	Non-sterile	Same

Summary of Non-Clinical Testing:

The product was tested in alignment with "Guidance for Industry and o FDA Staff - Surgical Masks - Premarket Notification [510(k)] Submission" Guidance Document
- ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- O Part 5: Tests For In Vitro Cytotoxicity
- ISO 10993-10: 2010 Biological Evaluation of Medical Devices Part O 10: Tests For Irritation And Skin Sensitization
- ASTM F2100-19, Standard Specification for Performance Of O Materials Used In Medical Face Masks
- ASTM F1862-17, Standard Test Method for Resistance of Medical O Face Masks to Penetration By Synthetic Blood (Horizontal Projection Of Fixed Volume At A Known Velocity)
- EN 14683: European standard for face masks O
- ASTM F2101-19, Standard Test Method for Evaluating The O Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using a Biological Aerosol Of Staphylococcus Aureus;
- ASTM F2299-03, Stand test method for determining the initial O efficiency of materials used in medical face masks to penetration by particulates using latex spheres;

6

16 CFR 1610, Standard for the Flammability of clothing textiles. O

	Bench Testing
Test	Standard/
Regulation	Acceptance
Criteria	Results
Barrier Testing -
Fluid resistance	ASTM F1862	Pass at 160mmHg	Passed
Barrier Testing-
Particle Filtration
Efficiency	ASTM F2299	Pass $\geq$ 98%	Passed
Barrier Testing -
Bacterial Filtration
Efficiency	ASTM F2101	Pass $\geq$ 98%	Passed
Safety Testing -
Flammability Class	16 CFR 1610	Class 1 ( $\geq$ 3.5
seconds)	Passed - Class I Non-
Flammable
Physical Testing -
Differential
Pressure Delta-P	EN14683	Passed