Medical Face Masks, Model Name:MY020003
Device Facts
| Record ID | K211165 |
|---|---|
| Device Name | Medical Face Masks, Model Name:MY020003 |
| Applicant | Huizhou Jie Bai Purification Co., Ltd. |
| Product Code | FXX · General, Plastic Surgery |
| Decision Date | Nov 9, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4040 |
| Device Class | Class 2 |
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.
Device Story
Medical Face Mask (Model MY020003) is a flat-pleated, single-use, non-sterile surgical mask. Device consists of three layers: inner and outer spunbond polypropylene fabric; middle meltblown polypropylene filter layer. Features include elastic ear loops (polyester/spandex) and integrated polyethylene nose piece for fit. Used in clinical settings or OTC by healthcare personnel and patients to reduce exposure to blood, body fluids, and particulates. Device acts as a physical barrier; no electronic or active components. Benefits include infection control and protection against cross-contamination.
Clinical Evidence
No clinical data. Bench testing only. Performance verified against ASTM F2100-19 standards: BFE (ASTM F2101-19) ≥98%, PFE (ASTM F2299-03) ≥98%, Differential Pressure (EN 14683:2019) <6.0, Synthetic Blood Penetration Resistance (ASTM F1862M-17) 120mmHg, and Flammability (16 CFR Part 1610) Class 1. Biocompatibility confirmed per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and sensitization).
Technological Characteristics
Three-layer construction: spunbond polypropylene (inner/outer), meltblown polypropylene (filter). Elastic ear loops (polyester/spandex), polyethylene nose piece. Flat pleated form factor. Non-sterile. Single-use. No electronic components or software.
Indications for Use
Indicated for use by adults as a single-use, disposable surgical mask to protect patients and healthcare personnel from transfer of microorganisms, body fluids, and particulate material in infection control practices.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- Disposable Surgical Mask (K202463)
Submission Summary (Full Text)
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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
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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
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### 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) |
|-------------------------------------------------|
|-------------------------------------------------|
| <input type="checkbox"/> Prescription Use (Part 21 CFR 201.Subpart D) | <input checked="" type="checkbox"/> 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<br>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.
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# 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<br>Comparisons | Proposed Devices<br>K211165 | Predicate Device<br>K202463 | Similarities/<br>Differences |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Name | MEDICAL FACE MASKS | Disposable Surgical Mask | / |
| Model | MY020003 | FILTECH M201 | / |
| Classification | Class 2 | Class 2 | Same |
| Intended use | The "MEDICAL FACE<br>MASKS" is intended to be<br>worn to protect both the<br>patient and healthcare<br>personnel from the transfer of<br>icroorganisms, body fluids<br>and particulate material. The<br>face mask is intended for use<br>in infection control practices<br>to reduce the potential<br>exposure to blood and body<br>fluids. This is a single use,<br>disposable device(s),<br>provided non-sterile. | The Disposable Surgical<br>Mask,FILTECH M201 is<br>intended to be worn to<br>protect both the patient and<br>health care personnel from<br>transfer of microorganisms,<br>body fluids and particulate<br>material.The Disposable<br>Surgical Mask is intended for<br>use in infection control<br>practices to reduce the<br>potential exposure to blood<br>and body fluids. This is a<br>single use,disposable<br>device(s), provided non-<br>sterile. | Same |
| ASTM F2100<br>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<br>Note 1 |
| Target<br>population | Adults | Adults | Same |
| Dimension<br>(length) | 180 mm | $175 \pm 5$ mm | Similar<br>Note 2 |
| Dimension<br>(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<br>Outer layer | Spunbond fabric<br>(Polypropylene) | Spunbond polypropylene | Same |
| Material of<br>middle layer | Meltblown fabric<br>(Polypropylene) | Melt blown polypropylene<br>filter | Same |
| Material of<br>inner layer | Spunbond fabric<br>(Polypropylene) | Spunbond polypropylene | Same |
| Material of<br>ear loops | Polyester and Spandex | Spandex | Similar<br>Note 3 |
| Material of<br>Nose piece | Polyethylene | Malleable polyethylene wire | Same |
| Colorants | / | Polypropylene (PP) master<br>batch | Similar<br>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:
1. ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
2. Bacterial Filtration Efficiency-Determine the bacterial filtration efficiency as directed in Test method F2101.
3. Differential Pressure -Determine breathing resistance or differential pressure as directed in EN 14683:2019,Annex C.
4. Sub-Micron Particulate Filtration-Determine particulate filtration efficiency as directed in Test Method F2299
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5. Resistance to Penetration by Synthetic Blood-Determine synthetic blood penetration resistance as specified in Test Method F1862.
| Stand<br>ard | Test item | Test method | Criteria | Results |
|----------------------|-------------------------------------------------|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| ASTM<br>F2100<br>-19 | BFE | ASTM F2101-19 | ≥98% | 32pass/<br>32tested<br>Accepted |
| | PFE | ASTM F2299-03(2017) | ≥98% | 32pass/<br>32tested<br>Accepted |
| | Differential<br>Pressure | EN<br>14683 :2019+AC (2019)(E),<br>Annex C | <6.0 | 32pass/<br>32tested<br>Accepted |
| | Synthetic<br>Blood<br>Penetration<br>Resistance | ASTM F1862M-17 | 120mmHg | 32pass/<br>32tested<br>Accepted |
| | Flammability | 16 CFR Part 1610<br>(As Amendment In 2008) | (A) There are no burn times;<br>or<br>(B) There is only one burn<br>time and it is equal to or<br>greater than 3.5 seconds; or<br>(C) The average burn time of<br>two or more specimens is<br>equal to or greater than 3.5<br>seconds. | Class 1 |
- Flammability-Determine flammability as specified in 16 CFR Part 1610. 6.
Biocompatibility:
- 1. ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro
- 2. ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation
and skin sensitization.
| Stand<br>ard | Test item | Test method | Criteria | Results |
|------------------------------|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| ISO<br>10993<br>-5:<br>2009 | In Vitro<br>Cytotoxicity | In this study, mammalian L-<br>929 cells were cultured in<br>vitro according to ISO 10993-<br>5:2009 to test the potential<br>cytotoxicity of the test article.<br>The test articles and the<br>control material were<br>separately placed in MEM<br>medium containing 10% fetal<br>bovine serum, and extracted<br>in a 37 °C incubator for 24<br>hours. After the end of the<br>extraction, the cell culture<br>medium in the 96-well plate<br>(104 cells/well) cultured for 24 | The 50% extract of the test<br>article should have at least<br>the same or a higher viability<br>than the 100% extract.<br>Otherwise the test should be<br>repeated.<br>The lower the Viab. % value,<br>the higher the cytotoxic<br>potential of the test article is.<br>If viability is reduced to <70%<br>of the blank, it has a<br>cytotoxic potential.<br>The Viab.% of the 100%<br>extract of the test article is<br>the final result. | Under the<br>conditions<br>of the<br>test, the<br>test article<br>was found<br>to be non-<br>cytotoxic |
| | | hours was removed and<br>replaced with the<br>corresponding extract,<br>cultured in 37℃, 5%<br>CO2, >90% humidity for 24<br>hours. After the culture, the<br>morphology and cell lysis of<br>the cells were observed<br>under the microscope, and<br>the cytotoxicity of the test<br>samples was determined by<br>MTT assay. | | |
| ISO<br>10993<br>-10:<br>2010 | Skin<br>Sensitization | we took guinea pigs to<br>observe the skin sensitization<br>of the test article according to<br>ISO 10993-10: 2010.<br>The test article were<br>extracted in Constant<br>Temperature Vibrator at<br>50°C, 60 rpm for 72 h by<br>0.9 % Sodium Chloride<br>Injection and Sesame Oil.<br>Mix 50:50 (by volume) stable<br>emulsion of Freund's<br>complete adjuvant with<br>selected solvent. Intradermal<br>induction and topical<br>induction were operated in<br>the clipped intrascapular<br>region of each animal. After<br>the topical induction phase<br>was completed on day 14, all<br>test and control animals were<br>challenged with the test<br>sample. The erythema and<br>edema of the challenge site<br>were observed to test the<br>sensitization response of the<br>test article. According to the<br>Magnusson and Kligman<br>scales, the response to<br>erythema and edema at each<br>application site of the skin<br>was described and scored 24<br>hours and 48 hours after the<br>challenge phase. | Magnusson and Kligman<br>grades of 1 or greater in the<br>test group generally indicate<br>sensitization, provided<br>grades of less than 1 are<br>seen in control animals.<br>If grades of 1 or greater are<br>noted in control animals, then<br>the reactions of test animals<br>which exceed the most<br>severe reaction in control<br>animals are presumed to be<br>due to sensitization.<br>If the response is equivocal,<br>rechallenge is recommended<br>to confirm the results from<br>the first challenge. The<br>outcome of the test is<br>presented as the frequency<br>of positive challenge results<br>in test and control animals. | Under the<br>conditions<br>of the<br>test, the<br>test article<br>was found<br>to be non-<br>sensitizing |
| | Skin<br>Irritation test | we took New Zealand white<br>Rabbits to observe the skin<br>irritation of the test article<br>according to ISO10993-<br>10:2010.<br>The test article were<br>extracted in Constant | Use only (24±2) h, (48±2) h<br>and (72±2) h observations for<br>calculation.<br>After the 72 h grading, all<br>erythema grades plus<br>oedema grades (24±2) h,<br>(48±2) h and (72±2) h were | Under the<br>conditions<br>of the<br>test, the<br>test article<br>was found |
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## 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.
