(174 days)
Not Found
No
The device description and performance studies focus on material properties and filtration efficiency, with no mention of AI or ML.
No.
The device acts as a barrier to prevent the transfer of microorganisms and fluids, which is a protective function rather than a therapeutic one (treating or curing a disease).
No
The device is a medical face mask intended for protection and infection control, not for diagnosing medical conditions.
No
The device description clearly outlines physical components (three layers of polypropylene, ear loops, nose piece) and bench testing related to material properties and performance, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect the wearer and others from the transfer of microorganisms, body fluids, and particulate material by being worn over the mouth and nose. This is a physical barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details the physical construction of a face mask. There is no mention of reagents, assays, or any components designed to analyze biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (blood, urine, tissue, etc.)
- Detecting or measuring a substance in a sample
- Providing information for diagnosis, monitoring, or screening of a disease or condition
- Performance Studies: The performance studies focus on the physical properties and safety of the mask (filtration efficiency, fluid resistance, biocompatibility), not on the accuracy or reliability of a diagnostic test.
- Predicate Device: The predicate device is a "Surgical Face Mask," which is also a physical barrier device, not an IVD.
In summary, the Disposable Medical Face Mask described is a personal protective equipment (PPE) device designed to prevent the spread of infectious agents through physical means, not a device used to diagnose or test for medical conditions using in vitro methods.
N/A
Intended Use / Indications for Use
The Disposable Medical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are 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.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The proposed devices are single use, three-layer, flat masks with ear loops and nose piece. The Disposable Medical Face Masks are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.
The proposed device, is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with natural rubber latex.
The nose piece contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene with steel wire.
The proposed devices are sold non-sterile and are intended to be single use, disposable devices.
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)
Summary of Non-clinical Testing
Disposable Medical Face Mask conforms to the following standards:
ASTM F 2100-19, Standard Specification for Performance of Materials Use in Medical Face Masks.
ISO 10993-1:2018, Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process.
Bench testing
The bench testing of Disposable Medical Face Mask include the following tests:
| *Fluid Resistance Performance: | Pass at 80 mmHg |
|---|---|
| *Particulate Filtration Efficiency: | 99.8% |
| *Bacterial Filtration Efficiency: | 99.8% |
| *Differential Pressure: |
§ 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.
0
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March 9, 2021
Wanxinda (Guangzhou) Technology Product Co., Ltd % Joyce Yang Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, Guangdong 518100 China
Re: K202710
Trade/Device Name: Disposable Medical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: September 7, 2020 Received: September 16, 2020
Dear Joyce Yang:
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 801and Part 809: medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or post-marketing 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 (OS) 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 mediation-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.
Ryan Ortega, PhD Acting 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
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Indications for Use
510(k) Number (if known) K202710
Device Name Disposable Medical Face Mask
Indications for Use (Describe)
The Disposable Medical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are 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.
| 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
510(k) Summary
510(k) Number: K202710 Date of summary prepared: March 6, 2021
Submission Sponsor 1.
| Applicant Name | Wanxinda(Guangzhou)Technology Product Co.,Ltd. |
|---|---|
| Address | Ling Xi Road, Accessory Section 2, Automobile Zone, Huadu District, Guangzhou, Guangdong, China. |
| Contact person | Zeng Xueping |
| Phone | 86-020-61816666 |
2. Submission correspondent
| Name | Shenzhen Joyantech Consulting Co., Ltd |
|---|---|
| Address | 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District, Shenzhen |
| Post Code | 518000 |
| Phone No. | 86-755-86069197 |
| Contact Person | Joyce Yang |
| joyce@cefda.com |
3. Device Identification
| Type of 510(k) submission: | Traditional |
|---|---|
| Trade Name: | Disposable Medical Face Mask |
| Model: | WXDKZ0001, WXDKZ0006 |
| Classification name: | Mask, Surgical |
| Common name: | Surgical face mask |
| Product Code: | FXX |
| Device Class: | II |
| Regulation Number: | 878.4040 |
Legally Marketed Predicate Device 4.
| Trade Name | Surgical Face Mask |
|---|---|
| Regulation number | 878.4040 |
| Regulation class | II |
| Regulation name | Surgical Apparel |
| 510(k) Number | K133070 |
| Product Code | FXX |
| Manufacturer | BH Medical Products Co.,Ltd. |
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Device Description 5.
The proposed devices are single use, three-layer, flat masks with ear loops and nose piece. The Disposable Medical Face Masks are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.
The proposed device, is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with natural rubber latex.
The nose piece contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene with steel wire.
The proposed devices are sold non-sterile and are intended to be single use, disposable devices.
6. Intended Use/ Indications for Use
The Disposable Medical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are 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.
| Comparison
item | Subject Device
(K202710) | Predicate Device
(K133070) | Comments |
|----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| Product
Code | FXX | FXX | Same |
| Regulation
Number | 21 CFR § 878.4040 | 21 CFR § 878.4040 | Same |
| Classificatio
n | Class II | Class II | Same |
| OTC use | Yes | Yes | Same |
| Intended
use &
Indication
s for Use | The Disposable Medical
Face Masks are intended to
be worn to protect both the
patient and healthcare
personnel from transfer of
microorganisms, body fluids
and particulate material.
These masks are intended
for use in infection control | The Disposable Surgical
Masks are intended to be
worn to protect both the
patient and healthcare
personnel from transfer of
microorganisms, body
fluids and particulate
material. These face
mask are intended for use | Same |
| Comparison
item | Subject Device
(K202710) | Predicate Device
(K133070) | Comments |
| | practices to reduce the
potential exposure to blood
and body fluids. This is a
single use ,disposable
device, provided non-sterile. | in infection control
practices to reduce the
potential exposure to
blood and body fluids.
This is a single
use ,disposable device,
provided non-sterile. | |
| Design
feature | Ear-loop | Ear-loop, Tie-on | Similar
Issue 1 |
| Usage | Single use | Single use | Same |
| Color | White, Blue | Blue, Green | Similar
Issue 2 |
| Size | Width: $175mm \pm 5%$
Length: $95mm \pm 5%$ | Width: $6.5" +/-0.25"$
Length: $3.5" +/-0.25"$
$4.2" +/-0.25"$ | Same |
| Sterile | Non-sterile | Non-sterile | Same |
| Material | Outer layer: polypropylene
non-woven | Outer layer: Spun-bond
polypropylene | Same |
| | Middle layer: Melt blown
fabric | Middle layer: Melt blown
polypropylene | Same |
| | Inner layer: polypropylene
non-woven | Inner layer:Spun-bond
polypropylene | Same |
| | Nose piece: PP+Steel wire | Nose piece: Aluminum
wire | Similar
Issue 3 |
| | Ear-loops: Spandex | Ear-loops:Polyester | Similar
Issue 4 |
| ASTM F
2100 Level | Level 1 | Level 1, Level 2, Level 3 | Similar
Issue 5 |
| Fluid
Resistance
Performance
ASTM F
1862-13 | Meet the ASTM F2100
Requirements for Level 1
Classification | Meet the ASTM F2100
Requirements for Level 1,
Level 2, Level 3
Classification | Similar
Issue 5 |
| | | | |
| | | | |
| Particulate
Filtration
Efficiency
ASTM F | Meet the ASTM F2100
Requirements for Level 1
Classification | Meet the ASTM F2100
Requirements for Level 1,
Level 2, Level 3 | Similar
Issue 5 |
| | | | |
| | | | |
| Comparison
item | Subject Device
(K202710) | Predicate Device
(K133070) | Comments |
| 2299 | | Classification | |
| Bacterial
Filtration
Efficiency
ASTM F
2101 | Meet the ASTM F2100
Requirements for Level 1
Classification | Meet the ASTM F2100
Requirements for Level 1,
Level 2, Level 3
Classification | Similar
Issue 5 |
| Differential
Pressure
(Delta P) EN
14683:2019+
AC : 2019 | Meet the ASTM F2100
Requirements for Level 1
Classification | Meet the ASTM F2100
Requirements for Level 1,
Level 2, Level 3
Classification | Similar
Issue 5 |
| Flammability
16CFR 1610 | Class 1 | Class 1 | Same |
| Cytotoxicity | Comply with ISO 10993-5
Non cytotoxic | Comply with ISO 10993-5
Non cytotoxic | Same |
| Irritation | Comply with ISO 10993-10
Non irritating | Comply with ISO 10993-
10 Non irritating | Same |
| Sensitization | Comply with ISO 10993-10
Non sensitizing | Comply with ISO 10993-
10 Non sensitizing | Same |
7. Technological characteristics comparison
5
6
Issue 1: Design differences do not introduce different questions of safety and effectiveness.
Issue 2: The color master batch of proposed device outer layer is different from the predicate device. This difference will not affect the performance of the mask. Moreover, the proposed product has been tested for biocompatibility and has no potential toxicity or irritation.
Issue 3: The nose piece of the proposed device is made polypropylene with steel wire, which of the predicate device is made by Malleable aluminum wire. The Nose piece is between the inner and outer layers of the mask, which does not contact with the human body directly when used. Moreover, the whole product has been tested for biocompatibility, and the test results confirm that they have good biocompatibility, these differences do not introduce different questions of safety and effectiveness.
lssue 4: The Ear-loops of the proposed device are made by spandex, which of the predicate device is made by polyester. The major chemical composition of the spandex is segmented polyurethane-urea, which is similar to polyester. In addition, the proposed devices have been tested for biocompatibility, and the test results confirm that they have good biocompatibility, these differences do not introduce different questions of safety and effectiveness.
Issue 5: The level of the proposed device is covered by the predicate device.
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8. Summary of Non-clinical Testing
Disposable Medical Face Mask conforms to the following standards:
ASTM F 2100-19, Standard Specification for Performance of Materials Use in Medical Face Masks.
ISO 10993-1:2018, Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process.
Bench testing
The bench testing of Disposable Medical Face Mask include the following tests:
| *Fluid Resistance Performance: | Pass at 80 mmHg |
|---|---|
| *Particulate Filtration Efficiency: | 99.8% |
| *Bacterial Filtration Efficiency: | 99.8% |
| *Differential Pressure: |