(204 days)
Not Found
No
The device description and performance studies focus on the physical properties and barrier performance of a medical face mask, with no mention of AI or ML technology.
No.
This device is a face mask intended for protection and infection control, not for treating a medical condition or disease.
No
Explanation: The device is a face mask intended to protect against the transfer of microorganisms and fluids, not to diagnose a medical condition.
No
The device description clearly outlines a physical product made of fabric and other materials, intended to be worn. It does not describe any software component.
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 healthcare personnel from the transfer of microorganisms, body fluids, and particulate material, and for reducing potential exposure to blood and body fluids. This is a physical barrier function.
- Device Description: The description details the physical construction and materials of the mask.
- Performance Studies: The performance studies focus on physical properties like bacterial filtration efficiency (BFE), particle filtration efficiency (PFE), differential pressure, synthetic blood penetration resistance, and flammability, as well as biocompatibility. These are all related to the mask's function as a physical barrier and its safety for contact with skin.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. IVDs are used in vitro (outside the body) to analyze biological samples.
This device is a medical device, specifically a surgical mask, which functions as a physical barrier. It does not perform any diagnostic testing.
N/A
Intended Use / Indications for Use
The "MEDICAL FACE MASKS " is intended to be worn to protect and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. The face mask is 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 "MEDICAL FACE MASKS" is single use, white color, without face shield, Flat Pleated type, utilizing elastic ear loops for wearing, and it has a Nose Piece design for fitting the facemask around the nose. The surgical face masks are manufactured with three layers. The inner and outer layers are made of Spunbond fabric (Polypropylene), and the middle filter layer is made of a meltblown fabric (Polypropylene). The subject device is held in place over the user's mouth and nose by two ear loops welded to the facemask. The elastic ear loop is made of Polyester and Spandex. The nose piece contained in masks is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of polyethylene. The "MEDICAL FACE MASKS" is sold non-sterile and are intended to be single-use, disposable devices.
This product contains no components made with natural rubber latex.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nose and mouth
Indicated Patient Age Range
Adults
Intended User / Care Setting
healthcare personnel / OTC
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 data was provided.
Performance tests included:
- ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
- Bacterial Filtration Efficiency-Determine the bacterial filtration efficiency as directed in Test method F2101.
- Differential Pressure -Determine breathing resistance or differential pressure as directed in EN 14683:2019,Annex C.
- Sub-Micron Particulate Filtration-Determine particulate filtration efficiency as directed in Test Method F2299
- Resistance to Penetration by Synthetic Blood-Determine synthetic blood penetration resistance as specified in Test Method F1862.
- Flammability-Determine flammability as specified in 16 CFR Part 1610.
Biocompatibility tests included:
- ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro Cytotoxicity. Results: Under the conditions of the test, the test article was found to be non-cytotoxic.
- ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization. Results: Under the conditions of the test, the test article was found to be non-sensitizing and non-irritating.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- BFE: ≥98% (32 pass / 32 tested)
- PFE: ≥98% (32 pass / 32 tested)
- 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.
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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 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.
November 9, 2021
Huizhou Jie Bai Purification Co.,Ltd. Zhong Xin Official Correspondent Dongjiang Road, Liangwu Village, Yuanzhou Town, Boluo County Huizhou, Guangdong 516123 China
Re: K211165
Trade/Device Name: Medical Face Masks, Model Name:MY020003 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: March 23, 2021 Received: April 19, 2021
Dear Zhong Xin:
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.
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
1
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 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,
Clarence W. Murray, III Ph.D. 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)
Device Name MEDICAL FACE MASKS (model : MY020003)
Indications for Use (Describe)
The "MEDICAL FACE MASKS " is intended to be worn to protect and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. The face mask is 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 201.Subpart D) | Over-The-Counter Use (21 CFR 201.Subpart C) |
|---|---|
| ----------------------------------------------------------------------- | --------------------------------------------------------------------------------- |
__ 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
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: November 09, 2021
1. Submitter's Information
The submitter of this pre-market notification is:
| Name: | Huizhou Jie Bai Purification Co.,Ltd. |
|---|---|
| Address: | Dongjiang Road, Liangwu Village, Yuanzhou Town, Boluo |
| County Huizhou, Guangdong, 516123 China | |
| Contact person: | Zhong Xin |
| Title: | Manager |
| E-mail: | zhongxin@suorec.com |
| Tel: | +86-13925539431 |
2. Device Identification
| 510(K) number: | K211165 |
|---|---|
| Trade/Device Name: | MEDICAL FACE MASKS |
| Models: | MY020003 |
| Common name: | Mask, Surgical |
| Regulation Number: | 878.4040 |
| Regulation Name: | Surgical apparel |
| Regulation Class: | Class 2 |
| Panel: | General Hospital |
| Product Code: | FXX |
3. Predicate Device
| 510(K) number: | K202463 |
|---|---|
| Device Name: | Disposable Surgical Mask |
| Manufacturer: | UNISOURCES GROUP LLC |
| Common name | Mask, Surgical |
| Regulation Number: | 878.4040 |
| Regulation Name: | Surgical apparel |
| Regulation Class: | Class 2 |
| Panel: | General Hospital |
| Product Code: | FXX |
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4. Device Description
The "MEDICAL FACE MASKS" is single use, white color, without face shield, Flat Pleated type, utilizing elastic ear loops for wearing, and it has a Nose Piece design for fitting the facemask around the nose. The surgical face masks are manufactured with three layers. The inner and outer layers are made of Spunbond fabric (Polypropylene), and the middle filter layer is made of a meltblown fabric (Polypropylene). The subject device is held in place over the user's mouth and nose by two ear loops welded to the facemask. The elastic ear loop is made of Polyester and Spandex. The nose piece contained in masks is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of polyethylene. The "MEDICAL FACE MASKS" is sold non-sterile and are intended to be single-use, disposable devices.
This product contains no components made with natural rubber latex.
5. Indication for use
The " MEDICAL FACE MASKS " is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. The face mask is 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.
5
6. Comparison to Predicate Device
Comparison to the predicate devices, the subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate device as summarized in the following table
| SE
Comparisons | Proposed Devices
K211165 | Predicate Device
K202463 | Similarities/
Differences |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Name | MEDICAL FACE MASKS | Disposable Surgical Mask | / |
| Model | MY020003 | FILTECH M201 | / |
| Classification | Class 2 | Class 2 | Same |
| Intended use | The "MEDICAL FACE
MASKS" is intended to be
worn to protect both the
patient and healthcare
personnel from the transfer of
icroorganisms, body fluids
and particulate material. The
face mask is 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. | The Disposable Surgical
Mask,FILTECH M201 is
intended to be worn to
protect both the patient and
health care personnel from
transfer of microorganisms,
body fluids and particulate
material.The Disposable
Surgical Mask is 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. | Same |
| ASTM F2100
Level | Level 2 | Level 2 | Same |
| Mask Styles | Flat Pleated | Flat Pleated | Same |
| Design features | Ear loop | Ear loop | Same |
| Layers | 3 | 3 | Same |
| Color | White | Blue outside; white inside | Similar
Note 1 |
| Target
population | Adults | Adults | Same |
| Dimension
(length) | 180 mm | $175 \pm 5$ mm | Similar
Note 2 |
| Dimension
(width) | 95 mm | $95 \pm 5$ mm | Same |
| Sterile | Non-sterile | Non-sterile | Same |
| Use | Single use, disposable | Single use, disposable | Same |
| Anatomical site | Nose and mouth | Nose and mouth | Same |
| Technology | Self-suction filter mask | Self-suction filter mask | Same |
| Environment of | OTC | OTC | Same |
| use | | | |
| Material of
Outer layer | Spunbond fabric
(Polypropylene) | Spunbond polypropylene | Same |
| Material of
middle layer | Meltblown fabric
(Polypropylene) | Melt blown polypropylene
filter | Same |
| Material of
inner layer | Spunbond fabric
(Polypropylene) | Spunbond polypropylene | Same |
| Material of
ear loops | Polyester and Spandex | Spandex | Similar
Note 3 |
| Material of
Nose piece | Polyethylene | Malleable polyethylene wire | Same |
| Colorants | / | Polypropylene (PP) master
batch | Similar
Note 1 |
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Note 1: The difference in color does not raise additional risk for safety and effectiveness. Biocompatibility evaluation has been performed on the finished device.
Note 2: The difference in dimension is so negligible that cannot raise additional risk for safety and effectiveness and the performance tests have been conducted on our device proposed, the results show no risk for safety and effectiveness.
Note 3: We introduce a material "Polyester" in ear loop. It shows no risk for safety and effectiveness after performance test and biocompatibility test.
All the differences don't affect the safety and effectiveness which is concluded after all the required testing, so no safety and effectiveness issues relating to the system come into conclusion.
8. Performance Data
Clinical test:
Clinical testing is not required.
Non-clinical data
The proposed device Medical face masks:
Performance:
-
ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
-
Bacterial Filtration Efficiency-Determine the bacterial filtration efficiency as directed in Test method F2101.
-
Differential Pressure -Determine breathing resistance or differential pressure as directed in EN 14683:2019,Annex C.
-
Sub-Micron Particulate Filtration-Determine particulate filtration efficiency as directed in Test Method F2299
7
- Resistance to Penetration by Synthetic Blood-Determine synthetic blood penetration resistance as specified in Test Method F1862.
| Stand
| ard | Test item | Test method | Criteria | Results |
|---|---|---|---|---|
| ASTM | ||||
| F2100 | ||||
| -19 | BFE | ASTM F2101-19 | ≥98% | 32pass/ |
| 32tested | ||||
| Accepted | ||||
| PFE | ASTM F2299-03(2017) | ≥98% | 32pass/ | |
| 32tested | ||||
| Accepted | ||||
| Differential | ||||
| Pressure | EN | |||
| 14683 :2019+AC (2019)(E), | ||||
| Annex C | 90% humidity for 24 | |||
| hours. After the culture, the | ||||
| morphology and cell lysis of | ||||
| the cells were observed | ||||
| under the microscope, and | ||||
| the cytotoxicity of the test | ||||
| samples was determined by | ||||
| MTT assay. | ||||
| ISO | ||||
| 10993 | ||||
| -10: | ||||
| 2010 | Skin | |||
| Sensitization | we took guinea pigs to | |||
| observe the skin sensitization | ||||
| of the test article according to | ||||
| ISO 10993-10: 2010. | ||||
| The test article were | ||||
| extracted in Constant | ||||
| Temperature Vibrator at | ||||
| 50°C, 60 rpm for 72 h by | ||||
| 0.9 % Sodium Chloride | ||||
| Injection and Sesame Oil. | ||||
| Mix 50:50 (by volume) stable | ||||
| emulsion of Freund's | ||||
| complete adjuvant with | ||||
| selected solvent. Intradermal | ||||
| induction and topical | ||||
| induction were operated in | ||||
| the clipped intrascapular | ||||
| region of each animal. After | ||||
| the topical induction phase | ||||
| was completed on day 14, all | ||||
| test and control animals were | ||||
| challenged with the test | ||||
| sample. The erythema and | ||||
| edema of the challenge site | ||||
| were observed to test the | ||||
| sensitization response of the | ||||
| test article. According to the | ||||
| Magnusson and Kligman | ||||
| scales, the response to | ||||
| erythema and edema at each | ||||
| application site of the skin | ||||
| was described and scored 24 | ||||
| hours and 48 hours after the | ||||
| challenge phase. | Magnusson and Kligman | |||
| grades of 1 or greater in the | ||||
| test group generally indicate | ||||
| sensitization, provided | ||||
| grades of less than 1 are | ||||
| seen in control animals. | ||||
| If grades of 1 or greater are | ||||
| noted in control animals, then | ||||
| the reactions of test animals | ||||
| which exceed the most | ||||
| severe reaction in control | ||||
| animals are presumed to be | ||||
| due to sensitization. | ||||
| If the response is equivocal, | ||||
| rechallenge is recommended | ||||
| to confirm the results from | ||||
| the first challenge. The | ||||
| outcome of the test is | ||||
| presented as the frequency | ||||
| of positive challenge results | ||||
| in test and control animals. | Under the | |||
| conditions | ||||
| of the | ||||
| test, the | ||||
| test article | ||||
| was found | ||||
| to be non- | ||||
| sensitizing | ||||
| Skin | ||||
| Irritation test | we took New Zealand white | |||
| Rabbits to observe the skin | ||||
| irritation of the test article | ||||
| according to ISO10993- | ||||
| 10:2010. | ||||
| The test article were | ||||
| extracted in Constant | Use only (24±2) h, (48±2) h | |||
| and (72±2) h observations for | ||||
| calculation. | ||||
| After the 72 h grading, all | ||||
| erythema grades plus | ||||
| oedema grades (24±2) h, | ||||
| (48±2) h and (72±2) h were | Under the | |||
| conditions | ||||
| of the | ||||
| test, the | ||||
| test article | ||||
| was found |
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9
9. Conclusion
Information included in this premarket notification supports the substantial equivalence of the proposed Medical face masks. The proposed device has the identical intended use, identical indication for us, identical performance, identical fundamental technology and identical biocompatibility as the predicate device K202463. The results of the testing support a determination of substantial equivalence.