Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)) is intended for single use by operating room personnel and other general healthcare workers and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.

Device Description

Non Woven Face Mask is a single use multi-layer mask with outer layer and inner layer (spunbond polypropylene) that sandwich a meltblown polypropylene filter material. There are two options for the surgical mask to be secured on users via earloops or ties. Earloops are of urethane elastic fiber and not made with natural rubber latex; and ties are of spunbond polypropylene and also not made with natural rubber latex. The nose piece is a pliable white aluminum strip, covered by polypropylene covering. All of the materials used in the construction of the surgical mask are being used in currently marketed devices. Non Woven Face Mask has two models which are VQN0185W and VQN0185B. They are basically the same, the only difference is VQN0185W adopts earloops and VQN0185B adopts ties to secure the mask on user.

AI/ML Overview

This is a 510(k) summary for a Non Woven Face Mask, indicating substantial equivalence to a predicate device. The information provided is for regulatory clearance of a medical device and does not involve AI or algorithms, human readers, or image analysis. Therefore, many of the requested fields are not applicable.

Here's an analysis of the provided text in relation to your request:

1. A table of acceptance criteria and the reported device performance

Test Parameter	Predicate Device Performance	Subject Device Performance	Acceptance Criteria (Implied by Predicate)
Fluid Resistance	Fluid resistant	Pass at 120mm Hg	Fluid resistant (Pass at 120mm Hg)
Particle Filtration Efficiency (PFE)	Average 99.54% at 0.1 micron	Average 99.74% at 0.1 μm	≥ 99.54% at 0.1 micron (or comparable)
Bacterial Filtration Efficiency (BFE)	>99.9%	Average 99.4%	>99.9% (or comparable)
Flammability Class	1	1	Class 1
Delta – P (Breathability)	Average 3.38 mmH2O/cm²	Average 2.7 mmH2O/cm²	Lower Delta-P is preferable
Biocompatibility	Non-cytotoxic, non-sensitizing, non-irritating	Non-cytotoxic, non-sensitizing, non-irritating	Non-cytotoxic, non-sensitizing, non-irritating

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes used for each performance test. It only states that "The performance tests of Non Woven Face Mask were conducted." The data provenance is not specified beyond indicating it's for the "subject device" (V&Q Manufacturing Corporation, Wuhan, Hubei, CHINA). It's implied to be prospective testing for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a medical device performance testing for a face mask, not an AI or image analysis device where expert ground truth is typically established. The performance tests are based on standardized methodologies (ASTM, ISO, MIL-M, CFR).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not an AI or image analysis study requiring adjudication of expert interpretations.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm or AI device. The device itself (the face mask) is tested for its standalone physical performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance tests are the established standards and methods outlined, such as ASTM F2299 for PFE, ASTM F1862 for fluid resistance, ASTM F 2101-14 for BFE, and ISO 10993 for biocompatibility. These are objective measurements against defined criteria, not expert consensus or pathology in the context of diagnostic AI.

8. The sample size for the training set

Not applicable. This is not an AI or machine learning device requiring a training set.

9. How the ground truth for the training set was established

Not applicable.

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 is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 25, 2018

V&Q Manufacturing Corporation % Tracv Che Registered engineer Feiying Drug & Medical Consulting Technical Service Group B-3F 3005, Bldg.1, Southward Ruifeng Business Center, No 22 Guimiao Road Shenzhen, 518000 CN

Re: K173062

Trade/Device Name: Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: January 3. 2018 Received: January 5, 2018

Dear Tracy Che:

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

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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,

Michael J. Ryan -S

for 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

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Indications for Use

510(k) Number (if known) K173062

Device Name

Non Woven Face Mask (Model: VQN0185W(earloop) and VQN0185B(ties))

Indications for Use (Describe)

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

K173062

(1) Applicant information

510 (k) owner's name:	V&Q Manufacturing Corporation
Address:	#B1614 optical valley time square, Wuhan, Hubei, CHINA

Contact person:	Jacky Jin
Phone number:	86-27-87680925
Fax number:	86-27-87680926
Email:	jackyj@chinavqmc.com
Date of summary prepared:	2018.01.24

(2) Proprietary name of the device

Trade name:	Non Woven Face mask (Models: VQN0185W (earloop) andVQN0185B (ties))
Regulation name:	Surgical apparel
Regulation number:	21 CFR 878.4040
Product code	FXX
Review panel:	General & Plastic Surgery
Regulation class:	Class II

Sponsor	Tiger Medical Products Ltd.
Device Name	Face Mask, Surgical Mask, Surgical Face Mask
510(k) Number	K122717
Product Code	FXX
Regulation Number	21 CFR 878.4040
Regulation Class	II

(3) Predicate device

(4) Description/ Design of device

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used in currently marketed devices. Non Woven Face Mask has two models which are VQN0185W and VQN0185B. They are basically the same, the only difference is VQN0185W adopts earloops and VQN0185B adopts ties to secure the mask on user.

(5) Indications for use

Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)) is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.

Component of DeviceRequiringBiocompatibility	Material ofComponent	Body Contact Category(ISO 10993-1)	Contact Duration(ISO 10993-1)
Non Woven Face Mask	Spunbondpolypropylene,meltblownpolypropylene,urethaneelastic fiber,whitealuminumstrip, bluecolor masterbatch	Surface-contactingdevice: skin	< 24hours

(6) Materials

The body-contacting material used in the Non Woven Face Mask have all passed biocompatibility test. Details can be seen in "Biocompatibility Discussion".

(7) Technological characteristics and substantial equivalence

Item	Subject device	Predicate device	Remark
Trade name	Non Woven Face Mask(Models: VQN0185W(earloop) and VQN0185B(ties))	Face Mask, Surgical Mask,Surgical Face Mask	/
510 (k) number	K173062	K122717	/
Regulationnumber	21 CFR 878.4040	21 CFR 878.4040	Identical
Regulationdescription	Surgical apparel	Surgical apparel	Identical

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	Product code	FXX	FXX	Identical
	Class	II	II	Identical
	Indications for use/ Intended use	Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)) is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.	Surgical mask (with different trade names: Face Mask, Surgical Mask, Surgical Face Mask) is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and airborne particulates.	Similar
	Inner layer	Spun-bond polypropylene	Spun-bond polypropylene	Similar
	Middle layer	Meltblown polypropylene	Meltblown polypropylene
	Outer layer	Spun-bond polypropylene	Spun-bond polypropylene
Materials	Nosepiece	White aluminum strip covered by PP covering	White aluminum strip with PP covering
	Headband	Urethane elastic fiber or spun-bond polypropylene	Urethane elastic fiber or spun-bond polypropylene
	Mask style	Flat pleated	Flat pleated	Identical
	Design feature	Earloop or tie-on	Earloop or tie-on	Identical
	Dimensions	175mm×95mm	Approx 170mm×90 mm	Similar
Latex		Not made with natural rubber latex	Latex Free	Identical
	Performance test result
	Fluid resistance	Pass at 120mm Hg	Fluid resistant	Similar
	Particle Filtration Efficiency	Average 99.74% at 0.1μ m	Average 99.54% at 0.1 micron	Similar
	Bacterial Filtration Efficiency	Average 99.4%	>99.9%	Similar
	Flammability Class	1	1	Identical
	Delta – P	Average 2.7 mmH2O/cm2	Average 3.38 mmH2O/cm2	Difference Note 1
	Biocompatibility	ISO10993-5 and ISO10993-10:	ISO10993-5 and ISO10993-10:	Identical

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Under the conditions of	Under the conditions of the
the studies employed, the	studies employed, the
device is non-cytotoxic,	device is non-cytotoxic,
non-sensitizing, and	non-sensitizing, and
non-irritating.	non-irritating.

A Note 1:
The Delta-P of the subject device is smaller than that of the predicate device which means user may feel cooler wearing the subject device, since a lower Delta-P translates to increased breathability.

(8) Non-clinical studies and tests performed

The performance tests of Non Woven Face Mask were conducted.

ASTM F2299 Standard Test Method for Determining the Initial Efficiency of Materials Used A in Medical Face Masks to Penetration by Particulates Using Latex Spheres
A ASTM F1862 Standard test method for resistance of medical face masks to penetration by synthetic blood (Horizontal projection of fixed volume at a known velocity)
A ASTM F 2101-14 Standard Test Method For Evaluating The Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus.
MIL-M-36954C Military Specification - Mask, Surgical, Disposable
16 CFR Part 1610 STANDARD FOR THE FLAMMABILITY OF CLOTHING TEXTILES A

During use, the Non Woven Face Mask will directly contact with user's skin, so we have it tested to demonstrate conformance to the following standards.

ISO 10993-5, Biological Evaluation Of Medical Devices -- Part 5: Tests For InVitro Cytotoxicity
A ISO 10993-10, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization

(9) Conclusion

Based on the non-clinical tests performed, the subject device is as safe, as effective, and performs as well as the predicate device.

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.