Medical surgical mask (Black mask, Level 1 and Level 3)

K213450 · Guangdong Kingfa Sci. & Tech.Co., Ltd. · FXX · Apr 5, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K213450
• Device Name: Medical surgical mask (Black mask, Level 1 and Level 3)
• Applicant: Guangdong Kingfa Sci. & Tech.Co., Ltd.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Apr 5, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

Medical surgical mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate matters. This device is single use and provided non-sterile.

Device Story

Medical surgical mask (Level 1 and Level 3) is a flat, pleated, single-use, non-sterile disposable mask. It features three layers: inner and outer polypropylene layers and a middle melt-blown polypropylene filter layer. Two polypropylene ear loops are ultrasonically welded to the mask body. A nose piece, integrated into the middle layer, allows for facial fitting. The mask is black, colored with Carbon black (CAS No. 1333-86-4). Used by healthcare workers in clinical settings to provide a barrier against microorganisms, bodily fluids, and particulate matter. The device is worn over the nose and mouth; the nose piece is adjusted by the user to ensure a secure fit. It provides protection for both the wearer and the patient during medical procedures.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against ASTM F2100-19, including Bacterial Filtration Efficiency (BFE), Differential Pressure, Particulate Filtration Efficiency (PFE), synthetic blood penetration resistance, and flammability. Biocompatibility testing (cytotoxicity, sensitization, irritation) performed per ISO 10993.

Technological Characteristics

Three-layer construction: polypropylene inner/outer layers, melt-blown polypropylene middle layer. Nose piece: polypropylene and metallic iron. Ear loops: polypropylene. Dimensions: 17.5 cm x 9.5 cm or 14.5 cm x 9.5 cm. Non-sterile. Colorant: Carbon black (CAS 1333-86-4). Complies with ASTM F2100-19, ISO 10993-5, and ISO 10993-10.

Indications for Use

Indicated for use by healthcare workers during procedures to protect patients and workers from transfer of microorganisms, bodily fluids, and particulate matter. Single-use, non-sterile.

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

• Medical surgical mask (K201622)
• Medical surgical mask (K202139)

Submission Summary (Full Text)

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April 5, 2022

Guangdong Kingfa Sci.&Tech. Co., Ltd. Yu Xiaoge Product Certification Engineer 28 Delong Avenue, Shijiao Town, Qingcheng District Qingyuan City, Guangdong 511500 China

Re: K213450

Trade/Device Name: Medical surgical mask (Black mask, Level 1 and Level 3) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 25, 2022 Received: March 1, 2022

Dear Yu Xiaoge:

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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Bifeng Qian, M.D., Ph.D. 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) K213450

Device Name

Medical surgical mask (Black mask, Level 1 and Level 3)

Indications for Use (Describe)

Medical surgical mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate matters. This device is single use and 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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# 510(k) Summary K213450

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

#### 1. Submitter's Information

510(k) Owner's Name: GUANGDONG KINGFA SCI.&TECH. CO., LTD. Establishment Registration Number: 3016785267 Address: No.28 Delong Avenue, Shijiao Town, Qingcheng District, Qingyuan City, Guangdong Province, China Postal Code:511500 Tel: [phone] Fax: [phone] Contact Person (including title): Yu Xiaoge (Product certification engineer) E-mail: [e-mail]

#### Date of the summary prepared: April 4, 2022

#### 2. Subject Device Information

Common Name: Medical surgical mask Classification Name: Mask, Surgical Trade Name: Medical surgical mask (Black mask, Level 1 and Level 3) Review Panel: General Hospital Product Code: FXX Regulation Number: 878.4040 Regulatory Class: II

#### 3. Predicate Device Information

#### 3.1. Predicate Device Information

Sponsor: Guangdong KINGFA Sci.&Tech.Co.,Ltd. Trade/Device Name: Medical surgical mask Classification Name: Mask, Surgical Common Name: Mask, Surgical 510(K) Number: K201622 Review Panel: General Hospital Product Code: FXX Regulation Number: 878.4040

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Regulation Class: II

#### 3.2. Predicate Device Information

Sponsor: Guangdong KINGFA Sci.&Tech.Co.,Ltd. Trade/Device Name: Medical surgical mask Classification Name: Mask, Surgical Common Name: Mask, Surgical 510(K) Number: K202139 Review Panel: General Hospital Product Code: FXX Regulation Number: 878.4040 Regulation Class: II

#### 4. Device Description

The medical surgical mask (model: Black mask, Level 3) is a flat pleated style mask with ear loops, and a nose piece design for fitting the mask around the nose. The mask is manufactured with three layers, the inner and outer layers are made of polypropylene, and the middle layer is made of melt-blown polypropylene. Ear loops are held to cover the users' mouth and nose by two polypropylene bands ultrasonically welded to the mask. The elastic ear loops are not made with natural rubber latex. The nose piece included in the mask is in the middle layer of the mask, to allow the user to fit the mask around their noses. The mask will be provided in black color, the colorant for the masks is Carbon black (CAS No.1333-86-4).

The subject device has 2 kinds of dimensions: 17.5 cm x 9.5 cm and 14.5 cm x 9.5 cm, and 2 kinds of protection performance: Level 1 and Level 3.

The mask is sold non-sterile and intended to be a single-use, disposable device.

#### 5. Intended Use / Indications for Use

Medical surgical mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorqanisms, bodily fluids, and particulate matters This device is single use and provided non-sterile.

#### 6. Comparison to predicate device and conclusion

The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

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| Elements of<br>Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Verdict | |
|-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|------|
| Company | Guangdong<br>KINGFA<br>Sci.&Tech.Co.,Ltd. | Guangdong KINGFA<br>Sci.&Tech.Co.,Ltd. | Guangdong KINGFA<br>Sci.&Tech.Co.,Ltd. | -- | |
| Trade Name | Medical surgical<br>mask | Medical surgical<br>mask | Medical surgical<br>mask | -- | |
| Classification<br>Name | Mask, Surgical | Mask, Surgical | Mask, Surgical | Same | |
| 510(k) Number | K213450 | K201622 | K202139 | -- | |
| Product Code | FXX | FXX | FXX | Same | |
| Classification | Class II | Class II | Class II | Same | |
| Intended Use /<br>Indications for<br>Use | Medical surgical<br>mask is intended for<br>use by healthcare<br>workers during<br>procedures to<br>protect both patients<br>and healthcare<br>workers against<br>transfer of<br>microorganisms,<br>bodily fluids, and<br>particulate matters<br>This device is single<br>use and provided<br>non-sterile. | Medical surgical<br>mask is intended for<br>use by healthcare<br>workers during<br>procedures to<br>protect both patients<br>and healthcare<br>workers against<br>transfer of<br>microorganisms,<br>bodily fluids, and<br>particulate matters<br>This device is single<br>use and provided<br>non-sterile. | This product is<br>indicated for infection<br>control practices in<br>the health care<br>industry. When worn<br>properly, the Medical<br>Surgical Mask is<br>intended to protect<br>both patient and<br>wearer from the<br>transfer of<br>microorganisms,<br>body fluids and<br>particulate material. | Same | |
| | Material | | | | |
| | Outer facing<br>layer | Polypropylene | Polypropylene | Polypropylene | Same |
| Middle layer | Polypropylene melt-<br>blown | Polypropylene melt-<br>blown | Polypropylene melt-<br>blown | Same | |
| Inner facing<br>layer | Polypropylene | Polypropylene | Polypropylene | Same | |
| Nose clip | Polypropylene and<br>metallic iron | Polypropylene and<br>metallic iron | Iron core<br>polypropylene strip | Same | |
| Elements of<br>Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Verdict | |
| Ear loops | Polypropylene | Polyester and<br>spandex elastic<br>band | Polyester and<br>spandex elastic<br>bands | Different<br>Note 1 | |
| Design<br>features | Color: black | Color: blue | Color: blue | Different<br>Note 1 | |
| Mask Style | Ear loop flat | Ear loop Flat | Ear loop flat | Same | |
| Specification<br>and<br>Dimension | 17.5*9.5; 14.5*9.5<br>cm;<br>Ear loops:150-185<br>mm | 17.5cmx9.5cm | 17.5cmx9.5cm | Different<br>Note 1 | |
| OTC use | Yes | Yes | Yes | Same | |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile | Same | |
| Use | Single Use,<br>Disposable | Single Use,<br>Disposable | Single Use,<br>Disposable | Same | |
| Product performance (Level 1) | | | | | |
| Performance<br>Testing<br>(according to<br>ASTM-2100:<br>2019) | Level 1 | Level 1 | -- | Same | |
| Bacterial<br>Filtration<br>Efficiency | Passed at<br>ave.99.3% | 99.2% | -- | Similar<br>Note 2 | |
| Differential<br>Pressure | Passed at ave.3.7<br>mmH2O/ cm² | <5.0 mmH2O/ cm² | -- | Similar<br>Note 2 | |
| Resistance to<br>penetration by<br>synthetic blood | Pass at 80 mmHg | Pass at 80 mmHg | -- | Same | |
| Particulate<br>Filtration<br>Efficiency | Passed at<br>ave.98.12% | 99.46% | -- | Similar<br>Note 2 | |
| Flammability | Class 1 | Class 1 | -- | Same | |
| Product performance (Level 3) | | | | | |
| Performance<br>Testing | Level 3 | -- | Level 3 | Same | |
| Elements of<br>Comparison<br>(according to<br>ASTM-2100:<br>2019) | Subject Device | Predicate Device 1 | Predicate Device 2 | Verdict | |
| Bacterial<br>Filtration<br>Efficiency | Passed at<br>ave.99.8% | -- | >99.9% | Similar<br>Note 2 | |
| Differential<br>Pressure | Passed at ave.4.27<br>mmH2O/ cm² | -- | 3.72 mm H2O/ cm² | Similar<br>Note 2 | |
| Resistance to<br>penetration by<br>synthetic blood | Pass at 160 mmHg | -- | Pass at 160 mmHg | Same | |
| Particulate<br>Filtration<br>Efficiency | Passed at<br>ave.99.58% | -- | 99.65% | Similar<br>Note 2 | |
| Flammability | Class 1 | -- | Class 1 | Same | |
| Biocompatibility | ISO 10993-5<br>ISO 10993-10 | ISO 10993-5<br>ISO 10993-10 | ISO 10993-5<br>ISO 10993-10 | Same | |

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# Comparison in Detail(s):

### Note 1:

Although the Ear loops", "Design features" and "Specification and Dimension" of subject device are different from the predicate devices, all of them meet the requirement of safety and essential performance standard ISO 10993-5 and ISO 10993-10. So, the differences between the predicate devices and subject device will not affect the safety and effectiveness of the subject device.

# Note 2:

Although the "Bacterial Filtration Efficiency" "Differential Pressure" and "Particulate Filtration Efficiency" of subject device are different from the predicate devices, all of them meet the requirement of safety and essential performance standard ASTM F2100-19. So, the differences between the predicate devices and subject device will not affect the safety and effectiveness of the subject device.

### 7. Summary of Non-Clinical Performance Testing

Medical surgical mask (Level 1)

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| Test item<br>(Performance<br>Level 1) | Test method | Pass<br>criteria | Test results |
|----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|--------------------------------------------------------|
| Bacterial filtration<br>efficiency | ASTM F2101-14 Standard Test<br>Method for Evaluating the<br>Bacterial Filtration Efficiency<br>(BFE) of Medical Face Mask<br>Materials, Using a Biological<br>Aerosol of Staphylococcus<br>aureus according to ASTM<br>F2100:2019 | ≥ 95% | 32/32 Passed at ave.99.3% / Pass |
| Differential<br>pressure (Delta-<br>P) | EN 14683: 2019, Annex C<br>Medical face masks -<br>Requirements and test methods<br>according to ASTM F2100:2019 | <5.0 mm<br>H2O/cm2 | 32/32 Passed at ave.3.7<br>mmH2O/cm2/ Pass |
| Particulate<br>Filtration<br>Efficiency | ASTM F2299-03 Standard Test<br>Method for Determining the Initial<br>Efficiency of Materials Used in<br>Medical Face Masks to<br>Penetration by Particulates<br>Using Latex Spheres according<br>to ASTM F2100:2019 | ≥ 95% | 32/32 Passed at<br>≥ave.98.12% / Pass |
| Resistance to<br>penetration by<br>synthetic<br>blood, minimum<br>pressure in<br>mmHg<br>for pass result | ASTM F1862/F1862M-17<br>Standard Test Method for<br>Resistance of Medical Face<br>Masks to Penetration by<br>Synthetic Blood (Horizontal<br>Projection of Fixed Volume at a<br>Known Velocity) according to<br>ASTM F2100:2019 | Fluid<br>resistant<br>claimed<br>at 80<br>mmHg | 32/32 Passed at 80 mmHg/<br>Pass |
| Flame spread | 16 CFR Part 1610 Standard for<br>the Flammability of Clothing<br>according to ASTM F2100:2019 | Class 1 | 32/32 Passed ≥3 Seconds<br>burn<br>Time-Class 1 / Pass |

| Medical surgical mask (Level 3) | | | |
|----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|--------------------------------------------------------|
| Test item | Test method | Pass | Test results |
| (Performance) | | criteria | |
| Level 3) | | | |
| Bacterial filtration<br>efficiency | ASTM F2101-14 Standard Test<br>Method for Evaluating the<br>Bacterial Filtration Efficiency<br>(BFE) of Medical Face Mask<br>Materials, Using a Biological<br>Aerosol of Staphylococcus<br>aureus according to ASTM<br>F2100:2019 | ≥ 98% | 32/32 Passed at ≥99.8% /<br>Pass |
| Differential<br>pressure (Delta-<br>P) | EN 14683: 2019, Annex C<br>Medical face masks -<br>Requirements and test methods<br>according to ASTM F2100:2019 | <6.0 mm<br>H2O/cm2 | 32/32 Passed at <4.24 mm<br>H2O/cm2/ Pass |
| Particulate<br>Filtration<br>Efficiency | ASTM F2299-03 Standard Test<br>Method for Determining the Initial<br>Efficiency of Materials Used in<br>Medical Face Masks to<br>Penetration by Particulates<br>Using Latex Spheres according<br>to ASTM F2100:2019 | ≥ 98% | 32/32 Passed at ≥99.58% /<br>Pass |
| Resistance to<br>penetration by<br>synthetic<br>blood, minimum<br>pressure in<br>mmHg<br>for pass result | ASTM F1862/F1862M-17<br>Standard Test Method for<br>Resistance of Medical Face<br>Masks to Penetration by<br>Synthetic Blood (Horizontal<br>Projection of Fixed Volume at a<br>Known Velocity) according to<br>ASTM F2100:2019 | Fluid<br>resistant<br>claimed<br>at<br>160mmHg | 32/32 Passed at 160<br>mmHg/ Pass |
| Flame spread | 16 CFR Part 1610 Standard for<br>the Flammability of Clothing<br>according to ASTM F2100:2019 | Class 1 | 32/32 Passed ≥3 Seconds<br>burn<br>Time-Class 1 / Pass |

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# 8. Biocompatibility Testing Summary

According to ISO 10993-1: 2018, the nature of body contact for the subject device is direct surface contact with skin and indirect contact with the respiratory tract, and the duration of the contact is A-Limited (<24 h). The following tests for the subject device were conducted to demonstrate that the subject device is biocompatible and safe for its intended use:

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| Title of the test | Purpose of the test | The source of references (Test method) | Acceptance criteria | Test results |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|--------------|
| In vitro<br>Cytotoxicity Test | Under the research conditions, determine whether the target device extract is cytotoxic. | ISO 10993-5:2009<br>Biological evaluation of medical devices-<br>Part 5: Tests for in vitro cytotoxicity | Under the conditions of the study, the subject device extract was determined to be non-cytotoxic. | Pass |
| Skin<br>Sensitization<br>Test | Under the research conditions, determine whether the non-polar and polar extracts of the target device are sensitive. | ISO 10993-10:2010<br>Biological evaluation of medical devices-<br>Part 10: Tests for irritation and skin sensitization | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-sensitizing. | Pass |
| Skin Irritation<br>Test | Under the research conditions, determine whether the non-polar and polar extracts of the target device are irritating. | ISO 10993-10:2010<br>Biological evaluation of medical devices-<br>Part 10: Tests for irritation and skin sensitization | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-irritating. | Pass |

### 9. Summary of Clinical Performance Test

No clinical study is included in this submission.

### 10. Final Conclusion

The conclusions drawn from the nonclinical tests that demonstrate that the subject device Medical surgical mask (Black mask, Level 1 and Level 3) is as safe, as effective, and performs as well as or better than the legally marketed device K201622 and K202139.