The Technoweb Sugical Mask is 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.

Device Description

Technoweb Surgical Mask is a type of surgical mask covers the user's nose and mouth. And provides a physical barrier to fluids and particulate materials. Technoweb Surgical Mask is a flat, pleated tie-on or elastic ear-loop mask consisting of three nonwoven layers; inner and outer cover web with middle different filter web sandwiched in between.

AI/ML Overview

This document describes the FDA's substantial equivalence determination for the Technoweb Surgical Mask (K172500) to the predicate device, 3M VFlexTM Health Care Particulate Respirator and Surgical Mask, Model 1805/1805S (K121069).

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Technoweb Surgical Mask are based on performance testing to demonstrate substantial equivalence to the predicate device. These criteria are primarily focused on the physical characteristics and protective capabilities of surgical masks.

Acceptance Criteria Category	Specific Criteria/Tests (Technoweb Surgical Mask)	Reported Device Performance (Technoweb Surgical Mask)	Predicate Device (3M VFlexTM Model 1805/1805S)	Comparison
Fluid Resistance	ASTM F1862	Fluid resistance at 12 mmHg.	YES (implies meeting a similar standard)	Similar
Material	Outer cover web: Polypropylene spunbond Stiffener web: Polypropylene spunbond Filter web: Polypropylene Inner web: Polypropylene Nose-Clip: Aluminum Staple: Steel Headband: Nylon	All listed materials are used.	Outer cover web: Felt Stiffener web: N/A Filter web: Felt Inner web: Felt Nose-Clip: Aluminum Staple: N/A Headband: Polyisoprene Nose foam: Plastic coating	Similar (some material differences noted but deemed acceptable for equivalence)
Design	Flat fold with ear loops	Flat fold with ear loops	Flat fold with Advanced Electrostatic Media (implied design feature aiding filtration)	Similar
Indications for Use	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.	Meets this indication.	Same indication.	Same
Single Use	Yes	Yes	Yes	Same
Biocompatibility	Biocompatibility assessment performed on patient contact materials.	Passed (implied by conclusion of safety and equivalence).	(Not explicitly detailed for predicate, but assumed to meet safety standards)	Implied as similar by equivalence conclusion.
Safety and Performance (General)	Laboratory testing regarding characteristics was performed to verify safety and performance.	Passed (implied by conclusion of safety and equivalence).	(Not explicitly detailed for predicate, but assumed to meet safety standards)	Implied as similar by equivalence conclusion.
Dimensions	TM-R is 212mm(W), 74mm(H) and model TM-S is 177.8mm(W), 138 mm(H).	Reported dimensions.	(Not explicitly detailed for predicate in the table, but assumed to be comparable for "similar" rating)	Similar

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide specific details on the sample sizes used for the various performance tests (e.g., fluid resistance, material testing, biocompatibility). It generally states "Laboratory testing regarding characteristics was performed on Technoweb surgical mask." It also doesn't specify the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Since this is a submission for a medical device (surgical mask), the "ground truth" is typically established by recognized national or international standards and test methods (e.g., ASTM F1862 for fluid resistance). The document does not mention the use of human experts to establish "ground truth" for the performance characteristics of the mask in the same way one might for an AI diagnostic imaging device. Instead, the performance is measured against established scientific criteria.

4. Adjudication Method

Not applicable for this type of device and testing. Performance is measured objectively against predefined standards, not through expert adjudication of subjective assessments.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a physical medical device (surgical mask), not an AI algorithm intended for diagnostic interpretation or human-in-the-loop assistance.

6. Standalone Performance Study (Algorithm Only)

Not applicable. This is not an algorithm. The "standalone performance" refers to the intrinsic physical and protective properties of the mask as tested against standards.

7. Type of Ground Truth Used

The ground truth used for evaluating the Technoweb Surgical Mask's performance is based on established industry standards and test methods, such as ASTM F1862 for fluid resistance, and general biocompatibility testing methodologies. These are objective, empirically defined criteria for surgical mask performance.

8. Sample Size for the Training Set

Not applicable. This is a physical device, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a physical surgical mask.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol is a stylized representation of a human figure, and the text is in bold, uppercase letters.

May 18, 2018

Yts Global Inc. Eddie Nguven Senior Logistics Specialist 7406 Alban Station Court Suite A108 Springfield, Virginia 22150

Re: K172500

Trade/Device Name: Technoweb Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: January 23, 2018 Received: January 29, 2018

Dear Eddie Nguven:

This letter corrects our substantially equivalent letter of March 01, 2018.

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. 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 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

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

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Page 2 - Eddie Nguyen

801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone

(1-800-638-2041 or 301-796-7100).

Sincerely,
FDA Tina Kiang

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control. and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

く

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Indications for Use

510(k) Number (if known) K172500

Device Name Technoweb Surgical Mask

Indications for Use (Describe)

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)

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510(k) SUMMARY

The assigned 510(k) number is : K172500

510(k) Owner/Applicant	Finetex EnE, inc
US Correspondent	Eddie NguyenYTS GLOBAL INC7406 ALBAN STATION COURT SUITE A108SPRINGFIELD, VA 22150(703)340-8178
Date Prepared	February 26, 2018
Trade Name	Technoweb Surgical Mask,
Common Name	Surgical Respirator
Classification Name	Surgical Apparel
Review Panel	General Hospital
Product Code	MSH
Device Classification	Class II per 21 CFR 878.4040
Predicate Device	3M VFlexTM Health Care Particulate Respirator and Surgical Mask, Model 1805/1805Scleared under K121069

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Proprietary	Finetex EnE, inc	3M Health Care	SubstantialEquivalence
Common Name	TechnoWeb Surgical Mask	3MTM VFlexTM HealTh CareParticulate Respirator andSurgical mask,	SAME
Model Number	TM-R, TM-S	1805/1805S	-
Manufacturer	Finetex EnE, inc	3M Health Care	-
510(k) Reference Number	K172500	K121069
Intended use	Surgical Mask/Respirator	Surgical Mask/Respirator	SAME
Design	Image: Finetex EnE, inc mask	Image: 3M Health Care mask	SIMILAR
Single Use	Yes	Yes	SAME
Material	Outsidecover web	Felt	Polypropylene spunbond	SIMILAR
	Stiffener web	N/A	Polypropylene spunbond	SIMILAR
	Filter web	Felt	Polypropylene	SIMILAR
	Inner web	Felt	Polypropylene	SIMILAR
	Nose-Clip	Aluminum	Aluminum	SAME
	Staple	N/A	Steel	SIMILAR
	Headband	Nylon	Polyisoprene	SIMILAR
	Nose foam	Plastic coating	N/A	SIMILAR
Dimensions	TM-R is 212mm(W), 74mm(H)and model TM-S is 177.8mm(W), 138 mm(H).		SIMILAR
Product style	Flat fold	Flat fold	SAME
Design Features	Ear loops	Advanced Electostatic Media	SIMILAR
Fluid Resistance(ASTM F1862)	fluid resistance at 12 mmHg.	YES	SIMILAR
Indication for Use	is 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.	is 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.	SAME
Device Description	Technoweb Surgical Mask is a type of surgical mask covers the user's nose and mouth. And provides a physical barrier to fluids and particulate materials. Technoweb Surgical Mask is a flat, pleated tie-on or elastic ear-loop mask consisting of three nonwoven layers; inner and outer cover web with middle different filter web sandwiched in between.
Intended Use	The Technoweb Sugical Mask is 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.
Model Numbers	TM-R and TM-S (Different Sizes)
TechnologicalCharacteristics	Technoweb Surgical Mask is a type of surgical mask covers the user's nose and mouth. And provides a physical barrier to fluids and particulate materials. Technoweb Surgical Mask is a flat, pleated tie-on or elastic ear-loop mask consisting of three nonwoven layers; inner and outer cover web with middle different filter web sandwiched in between.
PerformanceTesting	Laboratory testing regarding characteristics was performed on Technoweb surgical mask to verify its safety and performance. A biocompatibility assessment was performed on the patient contact materials of Technoweb surgical mask.
Conclusions	Finetex EnE, inc concludes that the Technoweb surgical mask is as safe and as effective and is substantially equivalent to predicate device, 3M Health Care Particulate Respirator and Surgical Mask,

Table - Substantial Equivalence Comparison.

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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.