(189 days)
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical face mask, with no mention of AI or ML.
No.
The device, a surgical face mask, is intended for infection control by creating a physical barrier to transfer of microorganisms and fluids, not for the treatment or diagnosis of a disease or condition.
No
The device, a surgical face mask, is intended to protect against the transfer of microorganisms and particulate material, and is used in infection control. It does not analyze data or provide a diagnosis of a medical condition.
No
The device description clearly outlines physical components (three-layer mask, ear loops, nose piece) and materials (polypropylene, steel wire), 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. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body) on specimens like blood, urine, or tissue.
- Device Description: The description details the physical construction of a face mask. There are no components or mechanisms described that would perform a diagnostic test.
- Performance Studies: The performance studies focus on the physical and biological properties of the mask (filtration efficiency, fluid resistance, flammability, biocompatibility), not on the accuracy or reliability of a diagnostic test.
- Lack of IVD Indicators: There is no mention of analyzing biological specimens, detecting specific analytes, or providing diagnostic information.
In summary, this device is a personal protective equipment (PPE) designed for physical protection, not for diagnosing a condition or disease.
N/A
Intended Use / Indications for Use
The Surgical 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.
Product codes
FXX
Device Description
The proposed devices are single use, three-layer, flat masks with ear loops and nose piece. The Surgical 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 colorants used for mask are Copper phthalocyanine, Titanium dioxide and Polyethylene. The proposed devices are sold non-sterile and are intended to be single use, disposable devices.
The proposed device including two models, WXDKZ0001 and WXDKZ0006, the difference is the color of the outer layer.
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)
Non-clinical Testing:
Surgical 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 of Surgical Face Mask include the following tests:
*Fluid Resistance Performance (32 out of 32 pass at 120mmHg)
*Particulate Filtration Efficiency (99.8%)
*Bacterial Filtration Efficiency (99.8%)
*Differential Pressure (4.0 mm H2O/cm²)
*Flammability (Class 1)
Biocompatibility testing:
Evaluations were conducted in accordance with ISO 10993-1. The tests include:
- Cytotoxicity (non-cytotoxic)
- Sensitization (non-sensitizing)
- Irritation (non-irritating)
No clinical tests were performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Fluid Resistance Performance: 32 out of 32 pass at 120mmHg
- Particulate Filtration Efficiency: 99.8%
- Bacterial Filtration Efficiency: 99.8%
- Differential Pressure (Delta P): 4.0 mm H2O/cm²
- Flammability: Class 1
- Cytotoxicity: non-cytotoxic
- Irritation: non-irritating
- Sensitization: non-sensitizing
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
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 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.
March 10, 2021
Wanxinda (Guangzhou) Technology Product Co., Ltd % Joyce No Last Name Provided Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, Guangdong 518100 China
Re: K202548
Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 13, 2020 Received: September 2, 2020
Dear Joyce No Last Name Provided:
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 and Part 809); 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.
For 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
2
Indications for Use
510(k) Number (if known) K202548
Device Name Surgical Face Mask
Indications for Use (Describe)
The Surgical 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 mask 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.
| 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
Submission Number: K202548
Date of Summary revised: March 10, 2021
1. Submission Sponsor
| 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: | Surgical Face Mask |
| Model: | WXDKZ0001, WXDKZ0006 |
| Classification name: | Mask, Surgical |
| Review Panel: | Surgical Apparel |
| Product Code: | FXX |
| Common name: | Surgical face mask |
| Device Class: | II |
| Regulation Number: | 878.4040 |
4. Legally Marketed Predicate Device
| 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. |
4
Device Description 5.
The proposed devices are single use, three-layer, flat masks with ear loops and nose piece. The Surgical 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 colorants used for mask are Copper phthalocyanine, Titanium dioxide and Polyethylene. The proposed devices are sold non-sterile and are intended to be single use, disposable devices.
The proposed device including two models, WXDKZ0001 and WXDKZ0006, the difference is the color of the outer layer.
| Model | Color | Performance Level |
|---|---|---|
| WXDKZ0001 | White | Level 2 |
| WXDKZ0006 | Blue | Level 2 |
6. Intended Use/ Indications for Use
The Surgical 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.
7. Summary of Technological Characteristics
| Comparison
item | Subject Device
(K202548) | 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 &
Indications for Use | The Surgical Face Masks are
intended to be worn to protect both
the patient and healthcare | The Disposable Surgical
Masks are intended to be
worn to protect both the | Same |
| Comparison
item | Subject Device
(K202548) | Predicate Device
(K133070) | Comments |
| | personnel from transfer of | patient and healthcare | |
| | microorganisms, body fluids and | personnel from transfer of | |
| | particulate material. These mask | microorganisms, body | |
| | are intended for use in infection | fluids and particulate | |
| | control practices to reduce the | material. These face mask | |
| | potential exposure to blood and | are intended for use in | |
| | body fluids. This is a single | infection control practices | |
| | use ,disposable device, provided | to reduce the potential | |
| | non-sterile. | exposure to blood and body | |
| Design
feature | Ear-loop | Ear-loop, Tie-on | Same |
| Usage | Single use | Single use | Same |
| Color | White, Blue | Blue, Green | Different
(Issue 1) |
| Size | Width:175mm±5% | Width:6.5"+/-0.25"
Length:3.5"+/-0.25"
4.2"+/-0.25" | Same |
| | Length: 95mm±5% | | |
| | The length of nose piece: 100mm±
5mm | | |
| | The length of ear loop: 190mm±
5mm | | |
| | | | |
| 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 | Different
(Issue 2) |
| | Ear-loops: Spandex | Ear-loops:Polyester | Different
(Issue 3) |
| Comparison
item | Subject Device
(K202548) | Predicate Device
(K133070) | Comments |
| ASTM F
2100 Level | Level 2 | Level 1, Level 2, Level 3 | Same |
| Fluid
Resistance
Performance
ASTM F
1862-13 | 32 out of 32 pass at 120mmHg | Level 1: 32 out of 32 pass
at 80mmHg
Level 2: 32 out of 32 pass
at 120mmHg
Level 3: 32 out of 32 pass
at 160mmHg | Same |
| Particulate
Filtration
Efficiency
ASTM F
2299 | 99.8% | Level 1: > 95%
Level 2: > 98%
Level 3: > 98% | Same |
| Bacterial
Filtration
Efficiency
ASTM F
2101 | 99.8% | Level 1: >95%
Level 2: > 98%
Level 3: > 98% | Same |
| Differential
Pressure
(Delta P) EN
14683:2019+
AC : 2019 | 4.0 mm H2O/cm² | Level 1: