Medical Protective Mask

K202107 · Guangdong Kingfa Sci. & Tech.Co., Ltd. · FXX · Jan 15, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K202107
• Device Name: Medical Protective Mask
• Applicant: Guangdong Kingfa Sci. & Tech.Co., Ltd.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Jan 15, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The Medical Protective Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Medical Protective 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 non-sterile.

Device Story

Medical Protective Mask (Model: KF-A F02(N)) is a single-use, four-layer, flat-folded surgical mask; features expanded chamber design; includes spun-bond polypropylene outer/inner layers and melt-blown/non-woven polypropylene filter layers; secured via spandex/polyester ear loops; includes iron-core polypropylene nose piece. Used in clinical settings by healthcare personnel and patients to provide a physical barrier against microorganisms, body fluids, and particulates; reduces potential exposure to blood and body fluids. Device is non-sterile, disposable, and intended for over-the-counter use.

Clinical Evidence

No clinical data. Safety and performance established via bench testing: Bacterial Filtration Efficiency (99.1%), Differential Pressure (5.04 mm H2O/cm²), Sub-micron Particulate Filtration Efficiency (99.9%), Fluid Resistance (120 mmHg), and Flammability (Class 1). Biocompatibility confirmed per ISO 10993-5 and ISO 10993-10 (non-cytotoxic, non-irritating, non-sensitizing).

Technological Characteristics

Four-layer construction: spun-bond polypropylene (outer/inner), melt-blown polypropylene and non-woven polypropylene (middle). Nose piece: iron core with polypropylene cover. Ear loops: spandex and polyester. Dimensions: 162x102 mm. Performance: ASTM F2100 Level 2. Non-sterile. No software or electronic components.

Indications for Use

Indicated for use by healthcare personnel and patients to reduce exposure to microorganisms, body fluids, and particulate material during 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

• Protective Face Mask for Medical Use (K201537)

Submission Summary (Full Text)

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January 15, 2021

Guangdong Kingfa Sci.&Tech.Co., Ltd. % Cassie Lee Manager Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3. Minjie Plaza, Shuixi Road Huangpu District Guangzhou, Guangdong 510700 China

Re: K202107

Trade/Device Name: Medical Protective Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: December 17, 2020 Received: December 28, 2020

Dear Cassie Lee:

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

Sincerely.

For CAPT Elizabeth Claverie, M.S. 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) K202107

Device Name Medical Protective Mask (Model: KF-A F02(N))

Indications for Use (Describe)

The Medical Protective Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Medical Protective 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) | <label><input type="checkbox"/> Reproduction Use (21 CFR 201 Subpart D)</label> <label><input checked="" type="checkbox"/> Own-Use Compounding (21 CFR 201 Subpart G)</label> |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

__ 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 for K202107

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 Post Code : 511500 Contact Person : Yu Xiaoge Tel : [phone] Fax : [phone] Email : [e-mail]

#### Application Correspondent :

Contact Person : Ms. Cassie Lee Share Info (Guangzhou) Medical Consultant Ltd. Address : No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District, Guangzhou, China Tel : [phone] Email : [e-mail]

#### 2. Subject Device Information

Type of 510(k): Traditional Classification Name: Mask, Surgical Common name: Surgical Mask Trade Name: Medical Protective Mask Model Name: KF-A F02(N) Review Panel: General Hospital Product Code: FXX Regulation Number: 878.4040 Regulatory Class: II

#### 3. Predicate Device Information

Sponsor: Shandong Shengquan New Material Co., Ltd. Trade Name: Protective Face Mask for Medical Use Common name: Surgical Mask Classification Name: Mask, Surgical 510(K) Number: K201537

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Review Panel: General & Plastic Surgery Product Code: FXX Regulation Number: 878.4040 Regulatory Class: II

#### 4. Device Description

The Medical Protective Mask is a single use, two-panel, flat-folded mask with ear loops and nose piece. The mask is designed into a C-shape when flat-folded. The C-shaped design allows for an expanded chamber for the mask in use.

The mask materials include four layers, the inner and outer layers are made of spun-bond polypropylene, and the two middle layers are melt-blown polypropylene and non-woven polypropylene filters, respectively.

The elastic ear loops are made of spandex and polyester, which are welded to the facemask to hold the mask in place over the users' mouth and nose. The elastic ear loops are not made with natural rubber latex. The nose piece is a Iron core covered with polypropylene. The dimensions of each mask are length 162±5 mm and width 102±5 mm. The dimensions of nosepiece is length 90±10 mm and width 5±0.5 mm, and the ear loop is length 185±5 mm and width 5±0.5 mm. The mask is a single use, disposable device, provided non-sterile in white color.

## 5. Intended Use / Indications for Use

The Medical Protective Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Medical Protective 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 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.

| Elements of<br>Comparison | Subject Device | Predicate Device | Verdict |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Company | GUANGDONG KINGFA<br>SCI.&TECH.CO., LTD. | Shandong Shengquan New<br>Material Co., Ltd. | -- |
| 510 (k) | K202107 | K201537 | -- |
| Trade Name | Medical Protective Mask | Protective Face Mask for<br>Medical Use | -- |
| Model | KF-A F02(N) | -- | -- |
| Classification<br>Name | Mask, Surgical | Mask, Surgical | Same |
| Classification | Class II Device, FXX (21 | Class II Device, FXX (21 | Same |
| Elements of Comparison | Subject Device | Predicate Device | Verdict |
| Intended use/ Indication for Use | CFR878.4040)<br>The Medical Protective Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Medical Protective 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 non-sterile. | CFR878.4040)<br>The Protective Face Mask for Medical Use is intended to be worn to protect both the patient and healthcare personnel from 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 non-sterile. | Same |
| Material | | | |
| Outer facing layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Middle layer | Polypropylene non-woven fabric<br>Melt-blown polypropylene | Polypropylene non-woven fabric<br>Melt-blown polypropylene | Same |
| Inner facing layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Nose clip | Iron core polypropylene strip | Plastic coated aluminum wire covered with sponge strips | Different<br>Note 1 |
| Ear Loops | Polyester and spandex | Polyester and spandex | Same |
| Design features | Color: white | Color: White | Same |
| Mask Style | Expanded chamber flat-folded, ear loops, 4 layers | Expanded chamber flat-folded, ear loops, 4 layers | Same |
| Specification and Dimension | Length: $16.2\pm0.5$ cm<br>Width: $10.2\pm0.5$ cm | Length: $16.5\pm0.8$ cm<br>Width: $10.5\pm0.5$ cm | Same<br>Note 2 |
| OTC use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| Performance Testing | ASTM F2100 Level 2 | ASTM F2100 Level 2 | Same |
| Fluid Resistance Performance | Pass at 120 mmHg | Pass at 120 mmHg | Same |
| Elements of<br>Comparison | Subject Device | Predicate Device | Verdict |
| Particulate<br>Filtration<br>Efficiency | 99.1% | 99.22% | Similar<br>Note 3 |
| Bacterial<br>Filtration<br>Efficiency | 99.9% | ≥9.89% | Similar<br>Note 3 |
| Differential<br>Pressure | On average of 5.04 mm H2O/cm² | Pass at 4.2 mmH2O/cm² | Similar<br>Note 3 |
| Flammability | Class 1 | Class 1 | Same |
| Latex | Not Made With Natural Rubber<br>Latex | Not Made With Natural Rubber<br>Latex | Same |
| Biocompatibility | | | |
| Cytotoxicity | Under the conditions of the<br>study, the subject device extract<br>was determined to be<br>non-cytotoxic. | Under the conditions of the<br>study, the subject device<br>extract was determined to be<br>non-cytotoxic. | Same |
| Irritation | Under the conditions of the<br>study, the subject device<br>non-polar and polar extracts<br>were determined to be<br>non-irritating. | Under the conditions of the<br>study, the subject device<br>non-polar and polar extracts<br>were determined to be<br>non-irritating. | Same |
| Sensitization | Under the conditions of the<br>study, the subject device<br>non-polar and polar extracts<br>were determined to be<br>non-sensitizing | Under the conditions of the<br>study, the subject device<br>non-polar and polar extracts<br>were determined to be<br>non-sensitizing | Same |

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## Comparison in Detail(s):

## Note 1:

Although the "Nose clip" of subject device is slightly difference with predicate device, it meets the requirement standard ISO 10993. The differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.

# Note 2:

Although the "Specification and Dimension" of subject device is slightly difference with predicate device. The differences between the predicate device and subject device is minimal, there may be some measurement errors, it will not affect the safety and effectiveness of the subject device.

## Note 3:

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Although the "Particulate Filtration Efficiency", "Bacterial Filtration Efficiency" and "Differential Pressure" of subject device is little difference with predicate device, it meets the requirement of essential performance standard ASTM 2100. The differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.

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

Medical Protective Mask (Model: KF-A F02(N)) has been evaluated the safety and performance by lab bench testing as following:

- Performance Testing summary

| Title of the test | Purpose of the test | The source of references<br>(Test method) | Acceptance criteria | Test results /Verdict |
|-------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|-----------------------------------------------|
| Bacterial filtration efficiency | In order to verify<br>whether the subject<br>equipment meets the<br>performance<br>requirements of<br>ASTM F2100 level 2,<br>Bacterial filtration<br>efficiency: $\ge$ 98% | ASTM F2101-14 Standard<br>Test Method for Evaluating<br>the Bacterial Filtration<br>Efficiency (BFE) of Medical<br>Face Mask Materials, Using<br>a Biological Aerosol of<br>Staphylococcus aureus<br>according to ASTM<br>F2100:2019 | $\ge$ 98% | 99.1% /<br>Pass |
| Differential<br>pressure<br>(Delta-P) | In order to verify<br>whether the subject<br>equipment meets the<br>performance<br>requirements of<br>ASTM F2100 level 2,<br>Differential pressure<br>(Delta-P): <6.0 mm<br>H2O/cm² | EN 14683: 2019, Annex C<br>Medical face masks -<br>Requirements and test<br>methods according to ASTM<br>F2100:2019 | <6.0 mm<br>H2O/cm² | On average<br>of 5.04 mm<br>H2O/cm2 /<br>Pass |
| Sub-micron<br>particulate<br>filtration<br>efficiency<br>at 0.1 µm of<br>Polystyrene<br>Latex Spheres | In order to verify<br>whether the subject<br>equipment meets the<br>performance<br>requirements of<br>ASTM F2100 level 2,<br>Sub-micron<br>particulate filtration<br>efficiency<br>at 0.1 µm of<br>Polystyrene Latex<br>Spheres: $\ge$ 98% | ASTM F2299-03 Standard<br>Test Method for<br>Determining the Initial<br>Efficiency of Materials Used<br>in Medical Face Masks to<br>Penetration by Particulates<br>Using Latex Spheres<br>according to ASTM<br>F2100:2019 | $\ge$ 98% | 99.9% /<br>Pass |
| Resistance to<br>penetration by | In order to verify<br>whether the subject | ASTM F1862/F1862M-17<br>Standard Test Method for | Fluid resistant<br>claimed | Fluid<br>Resistant |
| | | | | |
| synthetic<br>blood, minimum<br>pressure in mm<br>Hg<br>for pass result | equipment meets the<br>performance<br>requirements of<br>ASTM F2100 level 2,<br>Resistance to<br>penetration by<br>synthetic<br>blood, minimum<br>pressure in mm Hg<br>for pass result: Fluid<br>resistant claimed<br>at 120 mm Hg | Resistance of Medical Face<br>Masks to Penetration by<br>Synthetic Blood (Horizontal<br>Projection of Fixed Volume<br>at a Known Velocity)<br>according to ASTM<br>F2100:2019 | at 120 mm Hg | claimed at<br>120 mm Hg<br>/ Pass |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| | | | | |
| Flame spread | In order to verify<br>whether the subject<br>equipment meets the<br>performance<br>requirements of<br>ASTM F2100 level 2,<br>Flame spread: Class<br>1 | 16 CFR Part 1610 Standard<br>for the Flammability of<br>Clothing according to ASTM<br>F2100:2019 | Class 1 | Class 1 /<br>Pass |
| Shelf-life | In order to verify that<br>the subject<br>equipment still meets<br>the requirements of<br>ASTM F2100 level 2<br>after 2 years of aging | ASTM F 1980-16, Standard<br>Guide for Accelerated Aging<br>of Sterile Barrier Systems<br>for Medical Devices<br>ASTM F2100 – 19,<br>Standard Specification for<br>Performance of Materials<br>Used in Medical Face<br>Masks | Meets the<br>requirements of<br>ASTM F2100<br>level 2 | Pass |

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#### Biocompatibility Testing ●

According to ISO 10993-1:2009, the nature of body contact for the subject device is Surface Device category, Skin Contact and duration of contact is A-Limited (≤24h). The following tests for the subject device were conducted to demonstrate that the subject device is biocompatible and safe for its intended use:

| Title of the test | Purpose of the test | The source of references (Test method) | Acceptance criteria | Test results |
|----------------------------|------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|--------------|
| In vitro Cytotoxicity Test | Under the research conditions, determine whether the target device extract is cytotoxic. | ISO 10993-5:2009<br>Biological evaluation of medical devices- 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 Sensitization | Under the research | ISO 10993-10:2010 | Under the conditions | Pass |

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| Test | conditions, determine<br>whether the<br>non-polar and polar<br>extracts of the target<br>device are sensitive. | Biological evaluation of<br>medical devices— Part<br>10: Tests for irritation<br>and skin sensitization | of the study, the<br>subject device<br>non-polar and polar<br>extracts were<br>determined to be<br>non-sensitizing. | |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|------|
| Skin Irritation Test | Under the research<br>conditions, determine<br>whether the<br>non-polar and polar<br>extracts of the target<br>device are irritating. | ISO 10993-10:2010<br>Biological evaluation of<br>medical devices- Part<br>10: Tests for irritation<br>and skin sensitization | Under the conditions<br>of the study, the<br>subject device<br>non-polar and polar<br>extracts were<br>determined to be<br>non-irritating. | Pass |

## 8. Summary of Clinical Performance Test

No clinical study is included in this submission.

## 9. Date of the summary prepared: January 13, 2021

#### 10. Final Conclusion:

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K202107, the Medical Protective Mask (Model: KF-A F02(N)) is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K201537.