Disposable Surgical Mask/Fluid Resistant Procedure Mask

K202240 · Lhm Medical Technology (Hong Kong) Limited · FXX · Feb 25, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K202240
• Device Name: Disposable Surgical Mask/Fluid Resistant Procedure Mask
• Applicant: Lhm Medical Technology (Hong Kong) Limited
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Feb 25, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The Fluid Resistant Procedure Masks are intended to be worn to protect the patient and healthcare personnel from transfer of microorganisms, blood fluids, and particulate material. These face masks are 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

Disposable, flat-pleated, 3-layer surgical mask; worn via ear loops; includes nose piece for facial fit. Outer/inner layers: spun-bond polypropylene; middle layer: melt-blown polypropylene filter. Single-use, non-sterile. Used in clinical settings by healthcare personnel or patients for infection control; provides barrier protection against blood, body fluids, and particulates. Output is physical barrier; aids clinical decision-making by reducing cross-contamination risk; benefits patient/staff by minimizing exposure to infectious agents.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via 96 samples (3 lots) against ASTM F1862M-17 (fluid resistance), ASTM F2299 (particulate filtration >99.9%), ASTM F2101-19 (bacterial filtration >99.9%), EN 14683:2019 (differential pressure 3.52 mmH2O/cm²), and 16 CFR 1610 (flammability). Biocompatibility confirmed per ISO 10993-5 and ISO 10993-10.

Technological Characteristics

3-layer flat-pleated mask. Materials: spun-bond polypropylene (inner/outer), melt-blown polypropylene (filter). Ear loops: 88% Nylon/12% Spandex. Nose piece: iron wire covered by polypropylene. Dimensions: 17.5cm x 9.5cm. Non-sterile. Single-use. Tested to ASTM F2100-19 standards.

Indications for Use

Indicated for patients and healthcare personnel to protect against transfer of microorganisms, blood fluids, and particulate material; intended for infection control to reduce 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

• Surgical Face masks (Ear loops and Tie-on) (K160269)

Submission Summary (Full Text)

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February 25, 2021

LHM Medical Technology (Hong Kong) Limited Frank Cheng Senior Manager of Quality Control Unit No. 2. 3/F., Block A. Ko Fai Industrial Building, 7 Ko Fai Road,Yau Tong HongKong, 999077 China

Re: K202240

Trade/Device Name: Disposable Surgical Mask/Fluid Resistant Procedure Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 6, 2021 Received: February 9, 2021

Dear Frank Cheng:

We have reviewed vour 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 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 (DICE(@fda.hhs.gov) or phone [phone] or 301-796-7100).

Sincerely,

# Ryan Ortega -S

Ryan Ortega, PhD 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 Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K202240

Device Name Disposable Surgical Mask Fluid Resistant Procedure Mask

#### Indications for Use (Describe)

The Fluid Resistant Procedure Masks are intended to be worn to protect the patient and healthcare personnel from transfer of microorganisms, blood fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided nonsterile.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(k) Summary: K202240

#### l. Submitter

LHM Medical Technology (Hong Kong) Limited Unit No. 2, 3/F., Block A, Ko Fai Industrial Building, No. 7 Ko Fai Road, Yau Tong, Kowloon, Hong Kong

Establishment Registration Number: 3016866341

Contact person: Frank Cheng Position: Senior Manager of Quality Control Tel.: [phone]- Ext1169 E-mail: [e-mail]

Preparation date: Feb.15, 2021

## II. Proposed Device

| Trade Name of Device: | Disposable Surgical Mask / Fluid Resistant Procedure Mask |
|-----------------------|-----------------------------------------------------------|
| Common name: | Surgical Mask |
| Regulation Number: | 21 CFR 878.4040 |
| Regulatory Class: | Class II |
| Product code: | FXX |
| Review Panel: | General Hospital |

#### III. Predicate Devices

| 510(k) Number: | K160269 |
|-----------------|--------------------------------------------|
| Trade name: | Surgical Face masks (Ear loops and Tie-on) |
| Common name: | Surgical Mask |
| Classification: | Class II |
| Product Code: | FXX |
| Manufacturer | San-M Package Co., Ltd. |

#### IV. Device Description

The Fluid Resistant Procedure Masks are Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all have Nose Piece design for fitting the face mask around the nose. The Fluid Resistant Procedure Masks are manufactured with three layers.

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The outer layer is made of spun-bond polypropylene non-woven fabric. The middle layer with filtration function is made of melt blown polypropylene non-woven fabric. The inner layer which contacts with face is made of spun-bond polypropylene non-woven fabric.

The Fluid Resistant Procedure Masks are single use, disposable device, provided non-sterile.

## V. Indication for Use

The Fluid Resistant Procedure Masks are intended to be worn to protect the patient and healthcare personnel from transfer of microorganisms, blood fluids, and particulate material. These face masks are 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.

| Item | Proposed Device (K202240) | Predicate Device (K160269) | Comparison |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Trade Name | Disposable Surgical Mask/ Fluid Resistant Procedure Mask | Surgical Face masks (Ear loops and Tie-on) | - |
| Product Code | FXX | FXX | Same |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Class | Class II | Class II | Same |
| Mask Style | Flat-pleated, ear loops, 3 layers | Flat-pleated, ear loops or tie-on, 4 layers | Different² |
| Indication for Use | The Fluid Resistant Procedure Masks are intended to be worn to protect the patient and healthcare personnel from transfer of microorganisms, blood fluids, and particulate material. These face masks are intended for use in infection control | The Surgical facemasks are intended to be worn to protect the patient and healthcare personnel from transfer of microorganisms, blood fluid, and particulate material. These face masks are intended for use in infection control practices to reduce the | Same |

# VI. Comparison of Technological Characteristics with the Predicate Devices

Table 1 General Comparison

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| | | practices to reduce the<br>potential exposure to<br>blood and body fluids.<br>This is a single-use,<br>disposable device,<br>provided non-sterile. | potential exposure to<br>blood and body fluid.<br>This is a single-use,<br>disposable devices<br>provided non-sterile. | | |
|-----------------------------------------------|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|------------|
| Material | Inner<br>layer | Spun-bond<br>polypropylene | Polypropylene | | Same |
| | Middle<br>layer | Melt blown<br>polypropylene filter | 1. Polypropylene<br>spun-bond<br>2. Polypropylene melt<br>blown | | Different1 |
| | Outer<br>layer | Spun-bond<br>polypropylene | Polypropylene | | Same |
| | Ear<br>loops | 88% Nylon + 12%<br>Spandex | Ear loops: Polyester,<br>polyurethane;<br>Side tapes: Polyester<br>spun-bond (ear loops<br>mask only)<br>Ties tapes:<br>Polypropylene<br>spun-bond or polyester<br>spun-bond | | Different1 |
| | Nose<br>piece | Iron wire covered by<br>polypropylene | Polyethylene coated<br>steel wire | | Different1 |
| Color | | Blue | Blue ,white | | Different1 |
| Length | | 17.5cm | 17.5cm | 18.0cm | Different2 |
| Width | | 9.5cm | 9.0cm | 9.0cm | |
| OTC Use | | Yes | Yes | | Same |
| Sterile | | Non-sterile | Non-sterile | | Same |
| Single for Use | | Yes | Yes | | Same |
| Fluid Resistance<br>Performance<br>ASTM F1862 | | Pass at 160mmHg | Level 1: Pass at<br>80mmHg<br>Level 2: Pass at<br>120mmHg<br>Level 3: Pass at<br>160mmHg | | Different2 |

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| Particulate<br>Filtration<br>Efficiency<br>ASTM F2299 | >99.9% at 0.1μm | ≥98.0% | |
|-------------------------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------|------|
| Bacterial<br>Filtration<br>Efficiency<br>ASTM F2101 | >99.9% | ≥98% | |
| Differential<br>Pressure | Average 3.52 mmH2O/cm² | Level 1: <5 mmH2O/cm²<br>Level 2&3: <6 mmH2O/cm² | |
| Flammability<br>16 CFR 1610 | Class 1<br>Non Flammable | Class 1<br>Non Flammable | Same |
| In Vitro<br>Cytotoxicity<br>ISO 10993-5 | Under the conditions of<br>this study the device is<br>non-cytotoxic | Under the conditions of<br>this study the device is<br>non-cytotoxic | Same |
| Skin Irritation<br>ISO 10993-10 | Under the conditions of<br>this study the device is<br>non-irritating | Under the conditions of<br>this study the device is<br>non-irritating | Same |
| Skin Sensitization<br>ISO 10993-10 | Under the conditions of<br>this study the device is<br>non-sensitizing | Under the conditions of<br>this study the device is<br>non-sensitizing | Same |

#### Analysis:

1 The differences in the materials and color do not raise additional questions for safety and effectiveness of the device. The biocompatibility evaluation tests of the subject devices have been performed on the final finished device which includes all construction materials and color additives. The test results show pass the requirements.

2 The performances of proposed device have been performed the performance test according to method given in the ASTM F2100-19. The test results demonstrate that met the requirements in the standards. The minor difference between the proposed and predicate device does not affect the safety and effectiveness of the device.

# VII. Summary of Non-Clinical Testing

Non-clinical performance tests were conducted to verify that the proposed device met all design specifications. The below table shows the test results of test article,

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which demonstrated that the proposed device complies with the related standards. Each type of performance testing used 32 samples in each of 3 non-consecutive lots (totally 96 samples).

| Methodology/<br>Standard | Purpose | Acceptance<br>Criteria | Results |
|--------------------------|--------------------------------------|---------------------------------|-------------------------------------------|
| ASTM<br>F1862M-17 | Fluid Resistance<br>Performance | 29 out of 32 pass at<br>160mmHg | Pass (95/96) |
| ASTM F2299 | Particulate Filtration<br>Efficiency | ≥98% | Pass (96/96)<br>Average 99.9%<br>at 0.1µm |
| ASTM<br>F2101-19 | Bacterial Filtration<br>Efficiency | ≥98% | Pass (96/96)<br>Average 99.9% |
| EN 14683:2019<br>Annex C | Differential Pressure | <6mmH2O/cm² | Pass (96/96)<br>Average 3.52<br>mmH2O/cm² |
| 16 CFR 1610 | Flammability | Class I<br>Non Flammable | Pass (96/96)<br>Meet Class I |

| Table 2 Performance Testing | |
|-----------------------------|--|
|-----------------------------|--|

The biocompatibility of the proposed device was tested in accordance with ISO 10993 and passed acceptance criteria.

| Test Items | Standard | Result |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Cytotoxicity | ISO 10993-5:2009, Biocompatibility<br>Evaluation of Medical Device - Part 5:<br>Tests for In Vitro Cytotoxicity | Under the conditions of<br>the study, the subject<br>device was<br>non-cytotoxic. |
| Skin irritation | ISO 10993-10:2010, Biocompatibility<br>Evaluation of Medical Device - Part 10:<br>Tests for Irritation and Skin Sensitization | Under the conditions of<br>the study, the subject<br>device was non-irritating. |
| Skin<br>Sensitization | ISO 10993-10:2010, Biocompatibility<br>Evaluation of Medical Device - Part 10:<br>Tests for Irritation and Skin Sensitization | Under the conditions of<br>the study, the subject<br>device was<br>non-sensitizing. |

## Table 3 Biocompatibility Testing

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# VIII. Clinical Testing

No clinical study is included in this submission.

# IX. Conclusion

The proposed device has the same indication for use and has similar design features and technological characteristic as the predicate device. Performance testing data demonstrates that the proposed device is as safe, as effective and performs as well as the legally marketed predicate device.