Surgical Face Mask (Non-sterile)

K212398 · Hubei Kimsoul Industrial Co., Ltd. · FXX · Dec 15, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K212398
• Device Name: Surgical Face Mask (Non-sterile)
• Applicant: Hubei Kimsoul Industrial Co., Ltd.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Dec 15, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are intended for adult 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.

Device Story

Surgical face mask; three-layer, flat-pleated design; consists of mask body, nose piece, and two elastic ear loops. Mask body layers: inner/outer layers of polypropylene spunbond nonwoven; middle layer of polypropylene meltblown nonwoven. Nose piece: polyethylene. Ear loops: polyester and polyurethane. Device is single-use, disposable, and non-sterile. Used in clinical settings by healthcare personnel or patients for infection control. Provides physical barrier against fluids and particulates. Benefits patient and provider by reducing cross-contamination risk during medical procedures.

Clinical Evidence

No clinical data. Bench testing only. Performance testing included Bacterial Filtration Efficiency (BFE ≥99.9%), Particulate Filtration Efficiency (PFE 99.6%), Fluid Resistance (160 mmHg), Differential Pressure (3.7 mmH2O/cm²), and Flammability (Class 1). Biocompatibility testing (ISO 10993) confirmed the device is non-cytotoxic, non-sensitizing, and non-irritating.

Technological Characteristics

3-ply flat-pleated mask. Materials: Polypropylene spunbond (inner/outer), polypropylene meltblown (middle), polyethylene nose piece, polyester/polyurethane ear loops. Standards: ASTM F2100-20, ASTM F1862, ASTM F2101, ASTM F2299, EN 14683, 16 CFR 1610, ISO 10993. Dimensions: 145x95mm or 175x95mm. Non-sterile. No software or electronic components.

Indications for Use

Indicated for adult use in infection control practices to protect patients and healthcare personnel from transfer of microorganisms, body fluids, and particulate material, and to reduce potential exposure to blood and body fluids.

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

• Ear-Friendly Mask (K211105)

Reference Devices

• Disposable Surgical Mask (K202341)

Submission Summary (Full Text)

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December 15, 2021

Hubei Kimsoul Industrial Co., Ltd Grace Liu Consultant Shenzhen Joyantech Consulting Co. Ltd 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, Guangdong 518000 China

Re: K212398

Trade/Device Name: Surgical Face Mask (Non-sterile) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: October 16, 2021 Received: Nov 1, 2021

Dear Grace Liu:

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 (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.

For Clarence W. Murray III, PhD 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) K212398

Device Name Surgical Face Mask (Non-sterile)

#### Indications for Use (Describe)

The masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are intended for adult 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.

| 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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Product: Surgical Face Mask (Non-sterile)

Version: A/0

# 510(k) Summary

## K212398

#### 1. Contact Details

- 1.1 Applicant information

| Applicant Name | HUBEI KIMSOUL INDUSTRIAL CO., LTD |
|----------------|----------------------------------------------------------------------------|
| Address | NO. 1, Industrial Zone, Guohe Town, Xiantao City, Hubei<br>Province, China |
| Contact person | Faming Zhang |
| Phone No. | [phone] |
| E-mail | [e-mail] |
| Date Prepared | 2021-10-16 |

#### 1.2 Submission Correspondent

| Image: Logo | Shenzhen Joyantech Consulting Co., Ltd<br>1713A, 17th Floor, Block A, Zhongguan Times Square,<br>Nanshan District, Shenzhen, Guangdong Province, China |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| 卓 远 天 成 | |
| Phone No. | [phone] |
| Contact person | Grace Liu; Field Fu; |
| Contact person's e-mail | [e-mail]; [e-mail] |
| Website | http://www.cefda.com |

#### 2. Device Information

-

| Trade name | Surgical Face Mask (Non-sterile) |
|---------------------|----------------------------------|
| Common name | Surgical Face Mask |
| Model | 2020, 2030 |
| Classification | II |
| Classification name | Mask, Surgical |
| Product code | FXX |
| Regulation No. | 21 CFR 878.4040 |

#### 3. Legally Marketed Predicate Device

| Trade Name | Ear-Friendly Mask |
|---------------|-------------------|
| 510(k) Number | K211105 |
| Product Code | FXX |
| Manufacturer | RAY Co., Ltd |

#### 4. Legally Marketed Reference Device

Trade Name Disposable Surgical Mask

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| Version: A/0 | |
|--------------|--|
| | |

| 510(k) Number | K202341 |
|---------------|------------------------------------------------|
| Product Code | FXX |
| Manufacturer | Shanghai Jianzhong Medical Packaging Co., Ltd. |

#### 5. Device Description

The proposed device is a three-layer, flat pleated mask. Each mask is composed of a mask body, a nose piece and two ear loops. The mask body is manufactured with three layers, the inner layer and the outer layer are made of polypropylene spunbond nonwoven fabric, and the middle layer is made of polypropylene meltblown nonwoven fabric. It is held in place over the user's mouth and nose by two elastic ear loops welded to the mask body. The elastic ear loops are made of polyester and polyurethane, not made from natural rubber latex. The nose piece is in the layers of face mask to allow the user to fit the face mask around his nose, which is made of polyethylene.

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

#### 6. Intended Use/Indication for Use

The masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are intended for adult 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.

#### 7. Technological Characteristics Comparison

| Item | Proposed Device<br>(K212398) | Predicate Device<br>(K211105) | Reference Device<br>(K202341) | Comment |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product name | Surgical Face Mask<br>(Non-sterile) | Ear-Friendly Mask | Disposable Surgical Mask | / |
| Manufacturer | HUBEI KIMSOUL<br>INDUSTRIAL CO., LTD | RAY Co., Ltd | Shanghai Jianzhong<br>Medical Packaging Co.,<br>Ltd. | / |
| Product Code | FXX | FXX | FXX | Same |
| Regulation<br>Number | 21 CFR § 878.4040 | 21 CFR § 878.4040 | 21 CFR § 878.4040 | Same |
| Classification | Class II | Class II | Class II | Same |
| OTC use | Yes | Yes | Yes | Same |
| ASTM Level | Level 3 | Level 3 | Level 3 | Same |
| Indications for<br>use | The masks are intended to<br>be worn to protect both the<br>patient and healthcare<br>personnel from transfer of<br>microorganisms, body<br>fluids and particulate | When properly worn, the<br>Ear-Friendly Masks are<br>intended to protect both<br>patient and healthcare<br>workers from transfer of<br>microorganisms, body | The Disposable Surgical<br>Masks are intended to be<br>worn to protect both the<br>patient and healthcare<br>personnel from transfer of<br>microorganisms, body | Similar |
| | material. These masks are<br>intended for adult use in<br>infection control practices<br>to reduce the potential<br>exposure to blood and<br>body fluids. This is a single<br>use, disposable device(s),<br>provided non-sterile. | fluids and particulate<br>material. This device is non<br>sterile and for single use<br>only. | fluids, and particulate<br>material. These face masks<br>are intended for use in<br>infection control practices<br>to reduce the potential<br>exposure to blood and<br>body fluids. This is a<br>single-use, disposable<br>device, provided<br>non-sterile and sterile.<br>Models:<br>17.5*9.5cm-3ply (sterile),<br>14.5*9.5cm-3ply (sterile),<br>14.5*8cm-3ply (sterile)<br>17.5*9.5cm-3ply<br>(non-sterile),<br>14.5*9.5cm-3ply<br>(non-sterile),<br>14.5*8cm-3ply (non-sterile) | |
| Design<br>feature | Ear-loop | Ear-loop | Ear-loop | Same |
| Mask style | 3-ply, Flat Pleated | 3-ply, Flat Pleated | 3-ply, Flat Pleated | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Single Use, Disposable | Same |
| Color | White | White | Blue | Same |
| Specifications<br>and<br>Dimensions | 2020:<br>(145±5) mm x (95±5) mm<br>2030:<br>(175±5) mm x (95±5) mm | Length: (175±10) mm<br>Width: (95±10) mm | 17.5*9.5 cm<br>14.5*9.5 cm<br>14.5*8 cm | Different |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile, Sterile | Same |
| Materials | | | | |
| Outer layer | Spunbond polypropylene | Spunbond polypropylene | Polypropylene | Same |
| Middle layer | Meltblown polypropylene<br>filter | Meltblown polypropylene<br>filter | Polypropylene melt-blown | Same |
| Inner layer | Spunbond polypropylene | Spunbond polypropylene | Polypropylene | Same |
| Nose piece | Polyethylene (PE) | Single Galvanize wire,<br>coated By PE | Polyvinylchloride coated<br>iron wire | Different |
| Ear loop | Polyester and<br>Polyurethane | Elastic non-woven Fabric<br>(Made With PE&PP mixed) | Polyurethane | Different |
| Performance | | | | |
| Resistance | | | | |
| Bacterial<br>Filtration<br>Efficiency | Pass at ≥98% | Pass at ≥98% | Pass at >98.12% | Same |
| Particulate<br>Filtration<br>Efficiency | Pass at ≥98% | Pass at ≥98% | Pass at >98.01% | Same |
| Differential<br>Pressure<br>(Delta-P) | Pass at <6.0 mmH2O/cm² | Pass at <6.0 mmH2O/cm² | Pass at <4.6 mmH2O/cm² | Same |
| Flammability | Class 1 | Class 1 | Class 1 | Same |
| Biocompatibility | Under the conditions of the<br>studies employed, the<br>device is non-cytotoxic,<br>non-sensitizing,<br>and non-irritating. | Under the conditions of the<br>studies employed, the<br>device is non-cytotoxic,<br>non-sensitizing,<br>and non-irritating. | No Cytotoxicity, No<br>Sensitization and No<br>Irritation | Same |

#### Table 1 Substantial Equivalence Comparison

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Version: A/0

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Version: A/0

The proposed device has the same indication for use as the predicate device. The proposed device provides an additional dimension [Model 2020, size: (145±5) mm x (95±5) mm], which is different from the predicate device, but the reference device of the same dimension have been approved by FDA in K202341. The results of performance testing including biocompatibility evaluation performed on the final finished device demonstrates that the proposed device can meet the requirements of ASTM F2100 and ISO 10993. Therefore, the differences in the mask dimensions and materials don't raise any additional questions for safety and effectiveness, and the proposed device is substantially equivalent to the predicate device.

#### 8. Summary of Non-clinical Testing

#### 8.1 Biocompatibility testing

The biocompatibility tests were conducted to demonstrate the safety of the proposed device as similar to the predicate device. The test results demonstrated that the proposed device complies with ISO10993-1 (as shown in Table 2).

| Test | Purpose | Acceptance Criteria | Result |
|-------------------------------------------|----------------------------------------------------------------|------------------------------------------------------------------------------------------|--------|
| In vitro<br>Cytotoxicity<br>(ISO 10993-5) | Verify that the proposed device<br>extract is non-cytotoxic. | The extract is non-cytotoxic under<br>the research conditions. | Pass |
| Skin Irritation<br>(ISO 10993-10) | Verify that the proposed device<br>extract is non-irritating. | The polar and non-polar extracts are<br>non-irritating under the research<br>conditions. | Pass |
| Skin<br>Sensitization | Verify that the proposed device<br>extract is non-sensitizing. | The polar and non-polar extracts are<br>non-sensitizing under the research | Pass |

#### Table 2 Summary of Biocompatibility Tests

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#### HUBEI KIMSOUL INDUSTRIAL CO., LTD

Version: A/0

Product: Surgical Face Mask (Non-sterile)

| (ISO 10993-10) | conditions. | |
|----------------|-------------|--|
|----------------|-------------|--|

#### 8.2 Performance testing - Bench

The performance tests were conducted to demonstrate the effectiveness of the proposed device as similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards (as shown in Table 3).

- > ASTM F2100-20 Standard Specification for Performance of Materials Used in Medical Face Masks
- > ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
- > ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
- > ASTM F2299/F2299M-03 (R2017) Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
- > EN 14683:2019+AC:2019 Medical Face Masks - Requirements and Test Methods
- > 16 CFR 1610 Standard for the Flammability of Clothing Textiles

| Test | Purpose | Acceptance Criteria<br>per ASTM<br>F2100-20<br>(AQL=4.0%) | Results<br>(Statistics of three lots, 32<br>per lot) |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|------------------------------------------------------|
| Fluid<br>Resistance<br>(ASTM F1862) | Verify the fluid resistance of<br>the proposed device can meet<br>the requirements for Level 3<br>specified in ASTM F2100-20. | Pass at 160 mmHg | 96 out of 96 pass at 160<br>mmHg |
| Bacterial<br>filtration<br>efficiency (BFE)<br>(ASTM F2101) | Verify the bacterial filtration<br>efficiency of the proposed<br>device can meet the<br>requirements for Level 3<br>specified in ASTM F2100-20. | ≥98% | 99.8%~>99.9%<br>(Average: ≥99.9%) |
| Particulate<br>filtration<br>efficiency (PFE)<br>(ASTM F2299) | Verify the particulate filtration<br>efficiency of the proposed<br>device can meet the<br>requirements for Level 3<br>specified in ASTM F2100-20. | ≥98% | 99.0%~99.8%<br>(Average: 99.6%) |
| Differential<br>pressure<br>(Delta-P) | Verify the differential pressure<br>of the proposed device can<br>meet the requirements for | <6.0 mmH2O/cm² | (2.8~4.5) mmH2O/cm²<br>(Average: 3.7 mmH2O/cm²) |

Table 3 Summary of Performance Tests

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| (EN 14683) | Level 3 specified in ASTM<br>F2100-20. | | |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------|---------|------------------------------|
| Flammability<br>(16 CFR 1610) | Verify the flammability of the<br>proposed device can meet the<br>requirements for Level<br>3<br>specified in ASTM F2100-20. | Class 1 | 96 out of 96 pass at Class 1 |

### 9. Clinical Testing

No clinical study is included in this submission.

#### 10.Conclusions

The nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed device (K211105).