(268 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a standard medical face mask, with no mention of AI or ML.
No.
This device is a medical face mask intended to protect against the transfer of microorganisms, body fluids, and particulate material, not to treat a disease or condition.
No
This device is a medical face mask, intended to prevent the transfer of microorganisms, body fluids, and particulate material, not to diagnose a condition. The performance studies focus on physical barrier properties, not diagnostic accuracy.
No
The device description clearly outlines a physical, three-layer face mask made of spun-bond and melt-blown polypropylene with ear loops and a nose piece. The performance studies also focus on physical properties like fluid resistance, filtration efficiency, and flammability, which are characteristic of hardware devices, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the mask is for protecting against the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical construction of the mask (layers, ear loops, nose piece). There is no mention of reagents, assays, or any components used for analyzing biological samples.
- Performance Studies: The performance studies focus on the physical properties of the mask as a barrier (fluid resistance, filtration efficiency, breathability, flammability) and biocompatibility. These are not diagnostic performance metrics.
- Predicate Device: The predicate device is a "SURGICAL FACE MASK," which is also a physical barrier device, not an IVD.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, prevention, or treatment of a disease or condition. This face mask does not perform such a function.
N/A
Intended Use / Indications for Use
The Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face 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(s), provided non-sterile.
Product codes
FXX
Device Description
The Medical Face Masks are single use, three-layer, flat-pleated style with ear loops and nose piece. The 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 ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of Galvanized iron wire+ Polyethylene(PE). The medical face masks will be provided in blue. The medical face masks 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
healthcare personnel
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 proposed device was tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Medical face masks - Premarket Notification [510(k)] Submission issued on March 5, 2004.
Performance Testing:
- Fluid Resistance Performance: 32 Out of 32 pass at 120 mmHg(16.0 kPa) -> Pass
- Particulate Filtration Efficiency: 99.7% (≥ 98% acceptance criteria) -> Pass
- Bacterial Filtration Efficiency: 98.7% (≥ 98% acceptance criteria) -> Pass
- Differential Pressure (Delta P): 1.98 mmH20/cm² ( Pass
- Flammability: Class 1 (Class 1 acceptance criteria) -> Pass
Biocompatibility Testing:
- Cytotoxicity: Under the conditions of the study, the device is noncytotoxic. -> Pass
- Irritation: Under the conditions of the study, the device is nonirritating. -> Pass
- Sensitization: Under the conditions of the study, the device is nonsensitizing -> Pass
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Fluid Resistance: 32 Out of 32 pass at 120 mmHg (16.0 kPa)
Particulate Filtration Efficiency: 99.7%
Bacterial Filtration Efficiency: 98.7%
Differential Pressure (Delta P): 1.98 mmH20/cm²
Flammability: Class 1
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 the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
June 11, 2021
Chongqing Chaoke Industry Development Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China
Re: K202714
Trade/Device Name: Medical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX, Dated: April 30, 2021 Received: May 14, 2021
Dear Boyle Wang:
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); 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 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 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) K202714
Device Name Medical Face Mask
Indications for Use (Describe)
The Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face 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(s), 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 (K202714)
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.
1.0 submitter's Information
Name: CHONGQING CHAOKE INDUSTRY DEVELOPMENT CO.,LTD. Address: C31, Yangtze River Industry Park, Tea Garden New Zone, Nan'an District, Chongqing, China 400067 Tel: 86-23-62809222 Contact: Liu Xincheng Date of Preparation: Apr.30,2020
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device Information
Trade name: Medical Face Mask Common name: Surgical Face Mask Classification name: Surgical Face Mask Model: CK-MFM-002
3.0 Classification
Production code: FXX Regulation number: 21CFR 878.4040 Classification: Class II Panel: Surgical Apparel
4.0 Predicate Device Information
Manufacturer: WUHAN DYMEX HEALTHCARE CO., LTD. SURGICAL FACE MASK Device: 510(k) number: K182515
4
5.0 Device Description
The Medical Face Masks are single use, three-layer, flat-pleated style with ear loops and nose piece. The 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 ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of Galvanized iron wire+ Polyethylene(PE). The medical face masks will be provided in blue. The medical face masks are sold non-sterile and are intended to be single use, disposable devices.
6.0 Indication for Use Statement
The Medical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face 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(s), provided non-sterile.
7.0 Comparison to the Predicate Device
| Item | Subject Device
K202714 | Predicate Device
K182515 | Remark |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Product Name | Medical Face Mask | Surgical Face Mask | -- |
| Product Code | FXX | FXX | Same |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Class | II | II | Same |
| Intended Use&
Indications for use | The Medical Face Mask is
intended to be worn to
protect both the patient and
healthcare personnel from
transfer of microorganisms,
body fluids and particulate
material. These face
masks are intended for use
in infection control
practices to reduce the
potential exposure to blood | 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 face
masks are intended for
use in infection control | Same |
Table 1 General Comparison
5
| | | and body fluids. This is a
single use, disposable
device(s),provided
non-sterile. | practices to reduce the
potential exposure to
blood and body fluids.
This is a single use,
disposable device(s),
provided non-sterile. | |
|-----------------------|--------------------------|--------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Design features | | Ear Loops, 3 layers | Ear Loops, 3 layers | Same |
| Mask Styles | | Flat pleated | Flat pleated | Same |
| Material | Outer
facing
layer | Spun-bond polypropylene | Spun-bond
polypropylene | Same |
| | Middle
layer | Melt blown polypropylene
filter | Melt blown
polypropylene filter | Same |
| | Inner
Facing
layer | Spun-bond polypropylene | Spun-bond
polypropylene | Same |
| | Nose
piece | Galvanized iron wire+
Polyethylene(PE) | Malleable polyethylene
wire | Different* |
| | Ear
loops | not made with natural
rubber latex | not made with natural
rubber latex | Same |
| Color | | Blue | Blue | Same |
| Dimension
(Length) | | 175 mm +/- 8mm | 17.5 cm +/- 1cm | Same |
| Dimension (Width) | | 95 mm +/- 4mm | 9.5 cm +/- 1cm | Same |
| OTC use | | Yes | Yes | Same |
| Sterility | | Non-Sterile | Non-Sterile | Same |
| Single Use | | Yes | Yes | Same |
| Sterile | | No | No | Same |
| ASTM F2100 Level | | Level 2 | Level 2 | Same |
*The difference in the materials does not raise additional questions for safety and effectiveness. Performance testing including biocompatibility evaluation has been performed on the final finished device which includes all construction materials.
8.0 Non-Clinical Test Conclusion
The proposed device was tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Medical face masks - Premarket Notification [510(k)] Submission issued on March 5, 2004.
Table 2 - Performance Testing
| Item | Subject Device
K202714 | Acceptance Criteria | Result |
| ------ | --------------------------- | --------------------- | -------- |
|---|
6
| Fluid
Resistance
Performance
ASTM F1862 | 32 Out of 32 pass
at 120 mmHg(16.0 kPa) | 29 Out of 32 pass at
120 mmHg (16.0 kPa) | Pass |
|-------------------------------------------------------|--------------------------------------------|---------------------------------------------|------|
| Particulate
Filtration
Efficiency
ASTM F2299 | 99.7% | ≥ 98% | Pass |
| Bacterial
Filtration
Efficiency
ASTM F2101 | 98.7% | ≥ 98% | Pass |
| Differential
Pressure
(Delta P) MILM-
36954C | 1.98 mmH20/cm² |