Surgical Masks

K203524 · Bain Medical Equipment (Guangzhou) Co., Ltd. · FXX · Feb 25, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K203524
• Device Name: Surgical Masks
• Applicant: Bain Medical Equipment (Guangzhou) Co., Ltd.
• 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 Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body 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.

Device Story

Surgical mask; three-layer, flat-pleated design; ear loops; nose clip. Input: physical barrier to microorganisms/fluids. Operation: mechanical filtration via meltblown polypropylene middle layer; spunbond polypropylene inner/outer layers. Output: physical protection for wearer and patient. Used in clinical/infection control settings; worn by healthcare personnel and patients. Benefit: reduces exposure to blood, body fluids, and particulates. User adjusts nose clip for fit.

Clinical Evidence

No clinical data. Bench testing only. Performance metrics: Synthetic blood penetration (pass at 120 mmHg), Bacterial Filtration Efficiency (99.9% avg), Particulate Filtration Efficiency (98.8% avg), Differential Pressure (4.5 mm H2O/cm²), Flammability (Class I). Biocompatibility testing per ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization/irritation) showed no adverse effects.

Technological Characteristics

Three-layer flat-pleated mask. Materials: Spunbond polypropylene (inner/outer), meltblown polypropylene (filter), polyester/spandex (ear loops), polyethylene/galvanized iron (nose clip). Dimensions: 17.5cm x 9.5cm. ASTM F2100-2019 Level 2 compliant. Non-sterile. Biocompatibility: ISO 10993-5, ISO 10993-10.

Indications for Use

Indicated for use by patients and healthcare personnel to protect against transfer of microorganisms, body fluids, and particulate material, and to reduce potential exposure to blood and body fluids in 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

• Disposable Surgical Face Mask (K153496)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 25, 2021

Bain Medical Equipment (Guangzhou) Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box. 120-119 Shanghai. 200120 China

Re: K203524

Trade/Device Name: Surgical Masks Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: November 10, 2020 Received: December 1, 2020

Dear Diana Hong:

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,

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) K203524

Device Name Surgical Masks

Indications for Use (Describe)

The Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body 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.

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

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

- 1. Date of Preparation: 01/29/2021
- 2. Sponsor Identification

### Bain Medical Equipment (Guangzhou) Co., Ltd.

No.10 Juncheng Road, Eastern Area, Economic & Technological Development District, Guangzhou, China, 510760

Establishment Registration Number: 3013217742.

Contact Person: Mu Fangzhen Position: Management Representative Tel: [phone] ext.287 Fax: [phone] Email: [e-mail]

- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)

### Mid-Link Consulting Co., Ltd.

P.O. Box 120-119, Shanghai, 200120, China

Tel: [phone], Fax: [phone] Email: [e-mail]

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#### 4. Identification of Proposed Device

Trade Name: Surgical Masks Common Name: Surgical Face Mask Size: 17.5cm×9.5cm

Regulatory Information Classification Name: Mask, Surgical Classification: II; Product Code: FXX; Regulation Number: 21CFR 878.4040 Review Panel: General Hospital

#### Indication for use:

The Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body 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.

#### Device Description:

The Surgical Masks are single use, three-layer, flat-pleated masks with ear loops and nose clip. The inner and outer layers of the mask are made of spunbond polypropylene, and the middle layer is made of meltblown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the mask by ultrasound. The ear loops are made of polyester and spandex. The nose clip is made of polyethylene and galvanized iron wire. Users can adjust the nose clip according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off.

The size of the proposed device is 17.5cm×9.5cm. The proposed device is a Level 2 mask based on ASTM F2100-2019. The Surgical Masks are blue and provided non-sterile.

- ર. Identification of Predicate Device
510(k) Number: K153496 Product Name: Disposable Surgical Face Mask

#### 6. Summary of Non-Clinical Testing

The following performance data has been provided to demonstrate that the subject device meet the acceptance criteria in the standard.

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# K203524

| Name of the Test<br>Methodology / Standard | Purpose | Acceptance Criteria | Results |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|---------------------------|
| Resistance to Penetration<br>by Synthetic blood<br>ASTM F1862/F1862M-<br>17 Standard Test Method<br>for Resistance of Medical<br>Face Masks to<br>Penetration by Synthetic<br>Blood (Horizontal<br>Projection of Fixed<br>Volume at a Known<br>Velocity) | The test was performed in<br>accordance with ASTM<br>F1862-17 Standard Test<br>Method for Resistance of<br>Medical Face Masks to<br>Penetration by Synthetic<br>Blood (Horizontal<br>Projection of Fixed Volume<br>at a Known Velocity) to<br>evaluate the effectiveness of<br>the test sample from<br>possible exposure to blood<br>and other body fluids | No penetration at<br>120 mmHg | Pass at<br>120mmHg |
| Bacterial Filtration<br>Efficiency<br>ASTM F2101-2019<br>Standard Test Method for<br>Evaluating the Bacterial<br>Filtration Efficiency<br>(BFE) of Medical Face<br>Mask Materials, Using a<br>Biological Aerosol of<br>Staphylococcus aureus | The test was performed in<br>accordance with ASTM<br>F2101-19 Standard Test<br>Method for Evaluating the<br>Bacterial Filtration<br>Efficiency (BFE) of Medical<br>Face Mask Materials, using<br>a Biological Aerosol of<br>Staphylococcus aureus to<br>determine the bacterial<br>filtration efficiency (BFE) of<br>the test article. | ≥98% | Average 99.9% |
| Particulate Filtration<br>Efficiency<br>ASTM F2299/F2299M-<br>03 (2017) Standard Test<br>Method for Determining<br>the Initial Efficiency of<br>Material Used in medical<br>Face Masks to<br>Penetration by<br>Particulates using Latex<br>Spheres | The test was performed in<br>accordance with ASTM<br>F2299-03 (Reapproved<br>2017) Standard Test Method<br>for Determining the Initial<br>Efficiency of Materials Used<br>in Medical Face Masks to<br>Penetration by Particulates<br>Using Latex Spheres, to<br>determine the Particle<br>Filtration Efficiency | ≥98% | Average 98.8% |
| Differential Pressure<br>EN 14683:2019 Medical<br>face masks-<br>Requirements and test<br>methods | The test was performed in<br>accordance with EN<br>14683:2019 Medical face<br>masks-Requirements and<br>test methods, to determine<br>the differential pressure. | <6.0 mm H2O/cm² | Average 4.5 mm<br>H2O/cm² |
| Flammability<br>16 CFR 1610 Standard<br>for the Flammability of<br>Clothing Textiles<br>Corrections | The test was performed in<br>accordance with 16 CFR<br>1610 STANDARD FOR<br>THE FLAMMABILITY OF<br>CLOTHING TEXTILES to<br>evaluate the flammability of<br>the test sample. | Class I | Class I |

Table 1 Performance Testing

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- 7. Clinical Test Conclusion
No clinical study is included in this submission.

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- Summary of Technological characteristics 8.

| ITEM | Proposed Device K203524 | Predicate Device K153496 | Remark |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Product Code | FXX | FXX | Same |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Class | II | II | Same |
| Indication for Use | The Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body 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. | The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body 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(s), provided non-sterile. | Same |
| Mask style | Flat-pleated | Flat-pleated | Same |
| Design feature | Ear loop | Ear loop/Tie-on | Different 1 |
| Layers | Three | Three | Same |
| Color | Blue | Blue | Same |
| Dimension (cm) | 17.5cm×9.5cm | 17.5cm×9.5cm | Same |
| Level | Level 2 | Level 2 | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| Shelf life | 2 years | Unknown | Different 2 |
| Fluid resistance<br>ASTM F1862 | Pass at 120mmHg | Pass at 120mmHg | Same |
| Particulate filtration efficiency<br>ASTM F2299 | ≥98% | ≥98% | Same |
| Bacterial filtration efficiency<br>ASTM F2101 | ≥98% | ≥98% | Same |
| Differential pressure | <6.0mmH2O/cm2<br>EN 14683 | 4.0 mmH2O/cm2<br>MIL-M-36954C | Different 3 |
| Flammability<br>16 CFR Part 1610 | Class 1 | Class 1 | Same |
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |
| Patient Contacting Material | | | |
| Outer facing layer | Spunbond Polypropylene | Spun-bond polypropylene | |
| Middle layer | Melt-blown<br>Polypropylene<br>Filter | Melt blown polypropylene filter | |
| Inner facing layer | Spunbond Polypropylene | Spun-bond polypropylene | Different 4 |
| Nose clip | Polyethylene and<br>Galvanized<br>Iron | Malleable aluminum wire | |
| Ear loop | Polyester and Spandex | Polyester | |
| Biocompatibility | | | |
| Cytotoxicity | Comply with ISO 10993-5;<br>Under the conditions of<br>the<br>study, not cytotoxicity effect. | Under the conditions of the study,<br>not cytotoxicity effect. | Same |
| Sensitization | Comply with ISO 10993-10;<br>Under the conditions of the<br>study, not an irritant. | Under the conditions of the study,<br>not an irritant. | Same |
| Irritation | Comply with ISO 10993-10;<br>Under conditions of the study,<br>not a sensitizer. | Under conditions of the study, not<br>a sensitizer. | Same |

Table 2 Comparison of Technology Characteristics

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#### Different 1 - Design feature

The predicate devices are available in two types, ear loop type and tie-on type. The proposed device is only an ear loop mask and its type is included in the predicate device. Thus, this difference will not affect the safety and effectiveness of the proposed device.

#### Different 2 - Shelf life

Shelf life will affect the safety and effectiveness of mask. However, the performance testing of the proposed device after two years of aging has been conducted and the test results show that the proposed device after two years of aging meets the requirements of ASTM F2100-2019. Therefore, this difference will not affect the safety and effectiveness of the proposed device.

#### Different 3 - Differential pressure

The differential pressure test standards used for the proposed device and predicate device are different. The differential pressure testing for the proposed device was conducted according to Annex C of EN 14683. While the differential pressure testing for the predicate device was conducted according to MIL-M-36954C. The differential pressure test standard specified in ASTM F2100-19 standard is Annex C of EN 14683. In addition, the proposed device has been tested for differential pressure using EN 14683 test method, and the test results meet the requirements of ASTM F2100-19 standard. Thus, this difference will not affect the safety and effectiveness of the proposed devices.

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## Different 4 - Patient Contacting Material

The patient contacting material for the proposed device is different from predicate device. However, biocompatibility test has been performed on the proposed device and the results does not show any adverse effect. Thus, this difference in materials will not affect the safety and effectiveness of the proposed device.

- 9. Conclusion
The conclusions drawn from the non-clinical tests demonstrate that the subject device is as safe as effective, and performs as well as or better than the legally marketed predicate device K153496.