(119 days)
Not Found
No
The device is a simple surgical face mask and the description and performance studies focus on material properties and filtration efficiency, not computational analysis or algorithms.
No.
The device, a Non Woven Face Mask, is intended to prevent the transfer of microorganisms, blood, body fluids, and particulate materials, acting as a barrier rather than actively treating a disease or condition.
No
A non-woven face mask is intended to prevent the transfer of microorganisms, blood, and body fluids, acting as a barrier rather than diagnosing any condition.
No
The device description clearly outlines a physical, multi-layer mask made of materials like polypropylene and aluminum, with options for earloops or ties. The performance studies also focus on physical properties like filtration efficiency, fluid resistance, and flammability, which are characteristic of hardware devices. There is no mention of software components or functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. These tests are performed outside the body.
- Device Function: The description clearly states the device is a "Non Woven Face Mask" intended to be worn on the face to protect against the transfer of microorganisms, blood, body fluids, and particulate materials. It acts as a physical barrier.
- Intended Use: The intended use is for personal protection of healthcare workers, not for analyzing biological samples.
- Performance Studies: The performance studies listed (filtration efficiency, fluid resistance, flammability, biocompatibility) are all related to the physical barrier properties and safety of the mask when worn, not to diagnostic testing.
The device is a medical device, specifically a surgical mask, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / 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 and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
Product codes (comma separated list FDA assigned to the subject device)
FXX
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.
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
operating room personnel and other general healthcare workers and healthcare workers
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 performance tests of Non Woven Face Mask were conducted based on the following standards:
- 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
Biocompatibility tests based on ISO 10993-5 and ISO 10993-10 were also performed, demonstrating the device is non-cytotoxic, non-sensitizing, and non-irritating.
Key results:
- Fluid resistance: Pass at 120mm Hg
- Particle Filtration Efficiency: Average 99.74% at 0.1 microm
- Bacterial Filtration Efficiency: Average 99.4%
- Flammability Class: 1
- Delta – P: Average 2.7 mmH2O/cm2
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Fluid resistance: Pass at 120mm Hg
- Particle Filtration Efficiency: Average 99.74% at 0.1μ m
- Bacterial Filtration Efficiency: Average 99.4%
- Flammability Class: 1
- Delta – P: Average 2.7 mmH2O/cm2
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
1
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)
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.
| 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) and
VQN0185B (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
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
4
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 Device
Requiring
Biocompatibility | Material of
Component | Body Contact Category
(ISO 10993-1) | Contact Duration
(ISO 10993-1) |
|------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|-----------------------------------|
| Non Woven Face Mask | Spunbond
polypropylene,
meltblown
polypropylene,
urethane
elastic fiber,
white
aluminum
strip, blue
color master
batch | Surface-contacting
device: skin | 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.