Disposable Surgical Face Mask

K202387 · Guangdong Bida Medical Technology Co., Ltd. · FXX · Apr 23, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K202387
• Device Name: Disposable Surgical Face Mask
• Applicant: Guangdong Bida Medical Technology Co., Ltd.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Apr 23, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

Disposable Surgical Face Mask is intended to be worn to protect both patients and healthcare personnel from transfer of microorganisms, blood and body fluids, and particulates material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. The face mask is single use, disposable devices provide non-sterile.

Device Story

Disposable surgical face mask (Model MS001); three-layer flat-pleated design. Outer/inner layers: polypropylene spunbond; middle filter layer: polypropylene melt-blown. Features ear loops and malleable nose piece for fit. Single-use, non-sterile. Used in clinical settings for infection control; worn by healthcare personnel and patients. Provides physical barrier against blood, body fluids, and particulates. Benefits include reduced exposure to infectious agents.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against ASTM F2100-19, including fluid resistance (160 mmHg), particulate filtration efficiency (≥98%), bacterial filtration efficiency (≥98%), differential pressure (<6.0 mm H2O/cm²), and flammability (Class 1). Biocompatibility confirmed per ISO 10993-1 (cytotoxicity, irritation, sensitization).

Technological Characteristics

Three-layer flat-pleated mask. Materials: Polypropylene spunbond (outer/inner), polypropylene melt-blown (filter). Nose piece: Polyethylene-coated iron wire. Ear loops: Spandex. Dimensions: 17.5 cm x 9.5 cm. Non-sterile, single-use. Performance meets ASTM F2100-19 and ISO 10993 standards.

Indications for Use

Indicated for use by patients and healthcare personnel to protect against transfer of microorganisms, blood, body fluids, and particulate material in infection control settings.

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)
• 3M Hight Fluid-Resistant Procedure Mask (K191355)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K202387

Trade/Device Name: Disposable Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: March 23, 2021 Received: March 29, 2021

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.

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

Sincerely,

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) K202387

Device Name Disposable Surgical Face Mask (Model: MS001)

Indications for Use (Describe)

Disposable Surgical Face Mask is intended to be worn to protect both patients and healthcare personnel from transfer of microorganisms, blood and body fluids, and particulates material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. The face mask is single use, disposable devices provide non-sterile.

| Type of Use (Select one or both, as applicable) | <div> <table style="border: none;"><tr><td></td><td></td></tr></table> </div> | | |
|-------------------------------------------------|-------------------------------------------------------------------------------|--|--|
| | | | |

| | 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 of K202387

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

#### 1. Date of the summary: April 20, 2021

#### 2. Submitter's Information

510(k) Owner's Name: Guangdong Bida Medical Technology Co., Ltd. Establishment Registration Number: Applying Address: No.2, Xingfeng Rd, Shangsha Zhenxing District, Chang'an Town, Dongguan City, Guangdong Province, China Post Code: 523843 Contact name: Zhang Rong Tel: [phone] E-mail: [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]

## US Consultant Agent:

Company Name: UGK-LVM United Inc Address: 6547 N Academy Blvd, #2266 Colorado, Springs CO 80918, USA Contact Person: Jimmy Phone: [phone] Email: [e-mail]

#### 3. Subject Device Information

Type of 510(k): Traditional Classification Name: Mask, Surgical Trade Name: Disposable Surgical Face Mask

Report by Guangdong Bida Medical Technology Co., Ltd.

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Sponsor: Guangdong Bida Medical Technology Co., Ltd. Disposable Surgical Face Mask (Model: MS001) Subject Device: 510(k) Number K202387

Model Name: MS001 Review Panel: General Hospital Product Code: FXX Regulation Number: 878.4040 Regulatory Class: II

#### Predicate Device Information 4.

### Predicate Device 1:

Sponsor: San-M Package Co. Ltd. Trade Name: Surgical Face Masks (Ear loops and Tie-on) Classification Name: Mask, Surgical 510(K) Number: K160269 Review Panel: General Hospital Product Code: FXX Regulation Number: 878.4040 Regulatory Class: II

### Predicate Device 2:

Sponsor: 3M Health Care Trade Name: 3MTM Hight Fluid-Resistant Procedure Mask Classification Name: Mask, Surgical 510(K) Number: K191355 Review Panel: General Hospital Product Code: FXX Regulation Number: 878.4040 Requlatory Class: II

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

Disposable Surgical Face Mask is intended to be worn to protect both patients and healthcare personnel from transfer of microorganisms, blood and body fluids, and particulates material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. The face mask is single use, disposable devices provide non-sterile.

#### 6. Device Description

Report by Guangdong Bida Medical Technology Co., Ltd.

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| Sponsor: | Guangdong Bida Medical Technology Co., Ltd. |
|-----------------|----------------------------------------------|
| Subject Device: | Disposable Surgical Face Mask (Model: MS001) |
| 510(k) Number | K202387 |

The subject device is a three-layer and flat-pleated mask. The mask materials consist of non-woven/ outer layer (polypropylene spunbond), melt blown/ filter layer (polypropylene melt-blown) and non-woven/ inner layer (polypropylene spunbond). Each mask contains the ear loops to secure the mask over the users' mouth and face and includes a malleable nose piece to provide a firm fit over the nose.

The subject device is a single-use, disposable device, provided non-sterile.

#### 7. 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 1 | Predicate Device 2 | Remark |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Company | Guangdong Bida<br>Medical<br>Technology Co.,<br>Ltd. | SAN-M PACKAGE CO.,<br>LTD. | 3M Health Care | -- |
| 510 (k) | K202387 | K160269 | K191355 | -- |
| Trade Name | Disposable Surgical<br>Face Mask | Surgical Face Masks<br>(Ear loops and Tie-on) | 3MTM Hight<br>Fluid-Resistant<br>Procedure Mask | -- |
| Classification<br>Name | Mask, Surgical | Mask, Surgical | Mask, Surgical | Same |
| Classification | Class II | Class II | Class II | Same |
| Product Code | FXX | FXX | FXX | Same |
| Intended use | Disposable Surgical<br>Face Mask is<br>intended to be worn<br>to protect both<br>patients and<br>healthcare<br>personnel from<br>transfer of<br>microorganisms,<br>blood and body<br>fluids, and<br>particulates | The surgical face masks<br>are intended to be worn<br>to protect both the<br>patient and healthcare<br>personnel from transfer<br>of microorganisms, body<br>fluids, and particulate<br>material. These face<br>masks are intended for<br>use in infection control<br>practices to reduce the<br>potential exposure to | 3MTM Hight<br>Fluid-Resistant<br>Procedure Mask is<br>intended to be worn to<br>protect both the patient<br>and healthcare<br>personnel from<br>transfer of<br>microorganisms, body<br>fluids, and particulate<br>material. These face<br>masks are intended for | Same |

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| Sponsor: | Guangdong Bida Medical Technology Co., Ltd. |
|-----------------|----------------------------------------------|
| Subject Device: | Disposable Surgical Face Mask (Model: MS001) |
| 510(k) Number | K202387 |

| Elements of<br>Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| | face masks are<br>intended for use in<br>infection control<br>practices to reduce<br>the potential<br>exposure to blood<br>and body fluids.<br>The face mask is<br>single use,<br>disposable devices<br>provide non-sterile. | This is a single-use,<br>disposable device,<br>provided non-sterile. | 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. | |
| Materials | | | | |
| Outer facing<br>layer | Polypropylene<br>Spunbond | Polypropylene | Polypropylene<br>Spunbond, green | Similar<br>Note 4 |
| Middle filter<br>layer | Polypropylene Melt<br>blown | - Polypropylene<br>spunbond<br>- Polypropylene<br>meltblown | Polypropylene<br>Meltblown, white | Similar<br>Note 4 |
| Inner facing<br>layer | Polypropylene<br>Spunbond | Polypropylene | Polyethylene<br>Thermal-bonded, white | Similar<br>Note 4 |
| Nose piece | Polyethylene<br>coated iron wire | Polyethylene coated<br>steel wire | Polyethylene Coated<br>Steel Wire | Similar<br>Note 4 |
| Ear loops | Spandex | Polyester, polyurethane | Spandex elastic cord<br>(polyurethane core<br>with polyethylene<br>terephthalate /nylon<br>cover) | Different<br>Note 1 |
| Design<br>features | Color: Blue,<br>Ear loops, | Colors: white or blue<br>Visor option: polyester | Color: Green (Outer)<br>Tie Strings and Ear<br>loops | Different<br>Note 2 |
| Mask Style | Flat-pleated | Flat-pleated | Flat-pleated | Same |
| Dimensions | 17.5 cm x 9.5 cm | - Length: 90 ± 3 mm;<br>Width: 175 ± 5 mm;<br>- Length: 90 ± 3 mm<br>Width:<br>180 ± 5 mm | -Length: 6.9" ± 0.2"<br>-Width: 3.5" ± 0.3" | Different<br>Note 2 |
| OTC use | Yes | Yes | Yes | Same |

Report by Guangdong Bida Medical Technology Co., Ltd.

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| Sponsor: | Guangdong Bida Medical Technology Co., Ltd. |
|-----------------|----------------------------------------------|
| Subject Device: | Disposable Surgical Face Mask (Model: MS001) |
| 510(k) Number: | K202387 |

| Elements of<br>Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark |
|-----------------------------------------|-----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|-------------------------------|---------------------|
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile | Same |
| Use | Single Use,<br>Disposable | Single Use, Disposable | Single Use,<br>Disposable | Same |
| Performance<br>Testing | Level 3 | Level 1; Level 2; Level 3 | Level 3 | Same |
| Fluid<br>Resistance<br>Performance | Pass at 160 mm Hg | For Level 3:<br>Pass at 160 mm Hg | Passed at 160mm Hg | Same |
| Particulate<br>Filtration<br>Efficiency | ≥98% | For Level 3:<br>Pass at 99.7% | Passed at ≥98% @<br>0.1micron | Same |
| Bacterial<br>Filtration<br>Efficiency | ≥ 98% | For Level 3:<br>Pass at >99% | Passed at ≥98% | Same |
| Differential<br>Pressure | <6.0 mm H2O/cm2 | For Level 3:<br>Pass at 2.5 mm H2O/cm2 | Passed at <5 mm<br>H2O/cm2 | Different<br>Note 3 |
| Flammability | Class 1 | Class 1 | Class 1 | Same |
| Biocompatibility | | | | |
| Cytotoxicity | Under the<br>conditions of the<br>study, the subject<br>device was<br>non-cytotoxic. | Under the conditions of<br>the study, the subject<br>device was<br>non-cytotoxic. | Non-cytotoxic | Same |
| Irritation | Under the<br>conditions of the<br>study, the subject<br>device was<br>non-irritating. | Under the conditions of<br>the study, the subject<br>device was<br>non-irritating. | Non-irritating | Same |
| Sensitization | Under the<br>conditions of the<br>study, the subject<br>device was non-<br>sensitizing. | Under the conditions of<br>the study, the subject<br>device was non-<br>sensitizing. | Non-sensitizing | Same |

Comparison in Detail(s):

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| Sponsor: | Guangdong Bida Medical Technology Co., Ltd. |
|-----------------|----------------------------------------------|
| Subject Device: | Disposable Surgical Face Mask (Model: MS001) |
| 510(k) Number | K202387 |

## Note 1:

Although the "Nose piece" and "Ear loop" of subject device is a little different from the predicate devices, but they all met the ASTM F2100 and ISO 10993 standards required. So, the differences between the subject device and the predicate devices will not affect the safety and effectiveness.

## Note 2:

Although the "Design features" and "Dimensions" of subject device is a little different from predicate devices, but they all met the ASTM F2100 and ISO 10993 standards required. So, the differences between the subject device and predicate devices will not affect the safety and effectiveness.

## Note 3:

Although the "Differential Pressure" of subject device is a little different from predicate devices, but they all met the ASTM F2100 standard required. So, the differences between the subject device and predicate devices will not affect the safety and effectiveness.

## Note 4:

Although the materials in "Outer facing layer", "Middle filter layer" and "Nose piece" of subject device is a little different from predicate devices, but they all met the ISO 10993 series standard requirements. So, the differences between the subject device and predicate devices will not affect the safety and effectiveness.

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

## Performance Testing summary:

| Performance<br>Characteristics | Test Method | Acceptance<br>Criteria | Test<br>Results<br>/Verdict |
|---------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|-----------------------------|
| Fluid Resistance<br>Performance<br>(mmHg) | ASTM F1862/F1862M-17 Standard<br>Test Method for Resistance of<br>Medical Face Masks to Penetration<br>by Synthetic Blood (Horizontal<br>Projection of Fixed Volume at a<br>Known Velocity) according to ASTM<br>F2100: 2019 | Fluid resistant<br>claimed at 160<br>mm Hg | PASS |
| Particulate<br>Filtration Efficiency<br>Performance (%) | ASTM F2299-03 Standard Test<br>Method for Determining the Initial<br>Efficiency of Materials Used in<br>Medical Face Masks to Penetration<br>by Particulates Using Latex | ≥ 98% | PASS |

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| Sponsor: | Guangdong Bida Medical Technology Co., Ltd. |
|-----------------|----------------------------------------------|
| Subject Device: | Disposable Surgical Face Mask (Model: MS001) |
| 510(k) Number | K202387 |

| | Spheres according to ASTM<br>F2100: 2019 | | |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|------|
| Bacterial Filtration<br>Efficiency<br>Performance (%) | ASTM F2101-14 Standard Test<br>Method for Evaluating the Bacterial<br>Filtration Efficiency (BFE) of<br>Medical Face Mask Materials,<br>Using a Biological Aerosol of<br>Staphylococcus aureus according<br>to ASTM F2100: 2019 | ≥ 98% | PASS |
| Differential<br>Pressure (Delta-P)<br>(mm H2O/cm²) | EN 14683: 2019, Annex C Medical<br>face masks - Requirements and<br>test methods according to ASTM<br>F2100: 2019 | <6.0 mm<br>H2O/cm² | PASS |
| Flammability class<br>Class 1 | 16 CFR Part 1610 Standard for the<br>Flammability of Clothing according<br>to ASTM F2100: 2019 | Class 1 | PASS |

## Biocompatibility Testing Summary:

According to ISO 10993-1: 2018, the nature of body contact for the subject device is the Surface Device category, Skin Contact, and duration of the contact is Prolonged (>24 h to 30 d). The following tests for the subject device were conducted to demonstrate that the subject device is biocompatible and safe for its intended use:

| Test Item | Test Method | Proposed device | Result |
|---------------|---------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|--------|
| Cytotoxicity | ISO 10993-5: 2009 Biological<br>evaluation of medical devices-<br>Part 5: Tests for in vitro<br>cytotoxicity | Under the conditions of the study, the<br>subject device extract was<br>determined to be non-cytotoxic. | PASS |
| Irritation | ISO 10993-10: 2010 Biological<br>evaluation of medical<br>devices-Part 10: Tests for<br>irritation and skin sensitization | Under the conditions of the study, the<br>subject device non-polar and polar<br>extracts were determined to be<br>non-irritating. | PASS |
| Sensitization | ISO 10993-10: 2010 Biological<br>evaluation of medical<br>devices-Part 10: Tests for<br>irritation and skin sensitization | Under the conditions of the study, the<br>subject device non-polar and polar<br>extracts were determined to be<br>non-sensitizing. | PASS |

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#### Summary of Clinical Performance Test 9.

No clinical study is included in this submission.

### 10. Conclusion:

The conclusions drawn from the nonclinical tests demonstrate that the proposed device K202387 is as safe, as effective, and performs as well as or better than the legally marketed predicate devices K160269 and K191355.