(195 days)
Not Found
No
The 510(k) summary describes a standard disposable medical face mask and does not mention any AI or ML components or functionalities. The performance studies are based on physical and biological properties, not algorithmic performance.
No.
The device description and intended use clearly state that it is a disposable medical face mask for infection control, not a therapeutic device designed to treat a disease or condition.
No
The text explicitly states that the device is a medical face mask intended for protection and infection control, not for diagnosis.
No
The device description clearly outlines physical components (three-layer fabric, ear-loops, nose piece) and materials, indicating it is a hardware 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 both the patient and healthcare personnel 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.
- Performance Studies: The performance studies focus on the physical and filtration properties of the mask (blood penetration, filtration efficiency, breathability, flammability) and biocompatibility (cytotoxicity, irritation, sensitization). These are relevant to a barrier device, not a diagnostic test.
- Key Metrics: The key metrics are related to the mask's ability to filter and resist penetration, as well as its safety for contact with skin. These are not diagnostic metrics like sensitivity, specificity, or AUC.
IVD devices are used to examine specimens derived from the human body (such as blood, urine, or 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 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 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.
Product codes
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 outer layer is made of PPSB non-woven fabric, which the chemical composition is the mixture of Polypropylene and color master batch. Inner layer is made of Polyethylene, polypropylene and mixture of fiber finishes. And the middle layer is made of melt blown polypropylene filter.
The model of proposed device, YX001, 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 Malleable aluminum wire.
The proposed devices are sold non-sterile and are intended to be single use, disposable devices. The colorants used for mask are Copper phthalocyanine and Titanium dioxide.
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
Non clinical tests were conducted and conformed to the following standards and the requirements state in the Guidance for Industry and FDA Staff: Surgical Masks -Premarket Notification [510(k)] Submission issued on March 05, 2004.
- Resistance to penetration by synthetic blood (ASTM F1862): This procedure was performed to evaluate surgical facemasks and other types of protective clothing materials designed to protect against fluid penetration. Acceptance criteria: Pass at 120 mmHg. Subject device test result: Pass at 120 mmHg. Predicate device result: Pass at 120 mmHg, Pass at 160 mmHg.
- Sub-micron particulate filtration efficiency (ASTMF2299): This procedure was performed to evaluate the non-viable particle filtration efficiency (PFE) of the test article. Monodispersed polystyrene latex spheres (PSL) were nebulized (atomized), dried, and passed through the test article. Acceptance criteria: > 98%. Subject device test result: 99.9%. Predicate device result: > 98%.
- Bacterial Filtration Efficiency (ASTM F2101): The BFE test is performed to determine the filtration efficiency of test articles by comparing the bacterial control counts upstream of the test article to the bacterial counts downstream. Acceptance criteria: > 98%. Subject device test result: 99.9%. Predicate device result: > 98%.
- Differential Pressure (EN 14683:2019): The Delta P test is performed to determine the breathability of test articles by measuring the differential air pressure on either side of the test article using a manometer, at a constant flow rate. Acceptance criteria:
§ 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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March 8, 2021
Hunan EEXI Technology & Service 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: K202439
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: January 18, 2021 Received: February 8, 2021
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.
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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 (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 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.
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) K202439
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 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 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: K202439
Date of Summary prepared: March 4, 2021
1. Submission Sponsor
| Applicant Name | Hunan EEXI Technology & Service Co.,Ltd. |
|---|---|
| Address | No. 6 North of Pingtou Road, Liuyang Hi-tech Industrial Development Zone, Hunan China. |
| Contact person | Zhang Xianliang |
| Phone | +0086-15874115252 |
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 |
| Common name: | Surgical face mask |
| Model: | YX001 |
| Classification name: | Mask, Surgical |
| Product Code: | FXX |
| Device Class: | II |
| Regulation Number: | 878.4040 |
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4. Legally Marketed Predicate Device
| Trade Name: | Disposable Medical Face Mask |
|---|---|
| Regulation number: | 21 CFR 878.4040 |
| Regulation class: | II |
| Regulation name: | Surgical Apparel |
| 510(k) Number: | K153496 |
| Product Code: | FXX |
| Manufacturer: | Xiantao Rayxin Medical Products Co.,Ltd. |
5. 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 outer layer is made of PPSB non-woven fabric, which the chemical composition is the mixture of Polypropylene and color master batch. Inner layer is made of Polyethylene, polypropylene and mixture of fiber finishes. And the middle layer is made of melt blown polypropylene filter.
The model of proposed device ,YX001, is held in place over the user's mouth and nose bu 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 Malleable aluminum wire.
The proposed devices are sold non-sterile and are intended to be single use, disposable devices. The colorants used for mask are Copper phthalocyanine and Titanium dioxide.
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 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.
potential exposure to blood and body fluids.
7. Technological characteristics comparison
The Disposable Medical Face Mask is compared with the predicate device Disposable Medical Face Mask(K153496). The product characteristics are shown as follow:
5
| Comparison
item | Subject Device
(K202439) | Predicate Device
(K153496) | 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 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. | The Disposable 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 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. | Same |
| Design
feature | Ear-loop | Ear-loop, Tie-on | Similar
Issue 1 |
| Usage | Single use | Single use | Same |
| Color | Blue | Blue | Same |
| Size | (175±10)mm×(95±10)mm | (17.5±1)cm×(9.5±1)cm | Same |
| Sterile | Non-sterile | Non-sterile | Same |
| | Outer layer: Spun-bond
polypropylene | Outer layer: Spun-bond
polypropylene | Same |
| | Middle layer: Melt blown
polypropylene filter | Middle layer: Melt blown
polypropylene filter | Same |
| Comparison
item | Subject Device
(K202439) | Predicate Device
(K153496) | Comments |
| Material | Inner layer: Spun-bond
polypropylene | Inner layer:Spun-bond
polypropylene | Same |
| | Nose piece: PE+ Steel wire | Nose piece: Malleable
aluminum wire | Different
Issue 2 |
| | Ear-loops: Elastic fiber | Ear-loops: Polyester | Similar
Issue 3 |
| ASTM F
2100 Level | Level 2 | Level 2 | Same |
| Fluid
Resistance
Performance
ASTM F
1862-13 | Meet the ASTM F2100
Requirements for Level 2
Classification | Meet the ASTM F2100
Requirements for Level 2
Classification | Same |
| Particulate
Filtration
Efficiency
ASTM F
2299 | Meet the ASTM F2100
Requirements for Level 2
Classification | Meet the ASTM F2100
Requirements for Level 2
Classification | Same |
| Bacterial
Filtration
Efficiency
ASTM F
2101 | Meet the ASTM F2100
Requirements for Level 2
Classification | Meet the ASTM F2100
Requirements for Level 2
Classification | Same |
| Differential
Pressure
(Delta P)
MIL-M-
36954C | Meet the ASTM F2100
Requirements for Level 2
Classification | Meet the ASTM F2100
Requirements for Level 2
Classification | Same |
| 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 |
Table 1: General Comparison
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lssue 1: Design differences do not introduce different questions of safety and effectiveness.
lssue 2 : The nose piece of the proposed device is made by PE+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.
7
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.
Issue 3: The Ear-loops of the proposed device are made by elastic fiber, which of the predicate device is made by polyester. The major chemical composition of the elastic fiber is seqmented 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.
8. Summary of Non-clinical Testing
Non clinical tests were conducted and conformed to the following standards and the requirements state in the Guidance for Industry and FDA Staff: Surgical Masks -Premarket Notification [510(k)] Submission issued on March 05, 2004.
Standards:
- ASTM F2100-19 Standard Specification For Performance of Materials used in Medical Face Masks.
- ASTM F1862-13 Standard Test Method For Resistance of Medical Face Masks to Penetration by Synthetic Blood.
- ASTM F2299-03 Stand Test Method For Determining The Initial Efficiency Of Materials Used In Medical Face Masks To Penetration By Particulates Using Latex Spheres.
- 16 CFR 1610 Standard For The Flammability Of Clothing Textiles.
- ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
- ANSI/AAMI/ISO 11135:2014 Sterilization of health care products - Ethylene oxide - Requirements for Development, validation, and routine control of a sterilization process for Medical devices
- ISO 10993-5: 2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity.
- ISO 10993-10: 2010 Biological Evaluation Of Medical Devices Part 10: Tests ● For Irritation And Skin Sensitization.
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| Items | Purpose | Acceptance
criteria | Subject
device test
result
(K202439) | Predicate
device(K1
53496) |
|---------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|-----------------------------------------------|--------------------------------------------|
| Resistance to
penetration by
synthetic
blood(ASTM
F1862) | This procedure was
performed to evaluate
surgical facemasks and
other types of protective
clothing materials designed
to protect against fluid
penetration. | Pass at
120
mmHg | Pass at
120 mmHg | Pass at
120 mmHg
Pass at
160 mmHg |
| Sub-micron
particulate
filtration
efficiency
( ASTMF2299
) | This procedure was
performed to evaluate the
non-viable particle filtration
efficiency (PFE) of the test
article. Monodispersed
polystyrene latex spheres
(PSL) were nebulized
(atomized), dried, and
passed through the test
article. | > 98% | 99.9% | > 98% |
| Bacterial
Filtration
Efficiency
(ASTM F2101) | The BFE test is performed
to determine the filtration
efficiency of test articles by
comparing the bacterial
control counts up stream of
the test article to the
bacterial counts
downstream. | > 98% | 99.9% | > 98% |
| Differential
Pressure
(EN
14683:2019) | The Delta P test is
performed to determine the
breathability of test articles
by measuring the
differential air pressure on
either side of the test article
using a manometer, at a
constant flow rate. |