Surgical mask

K211552 · Shandong Shengquan New Materials Co., Ltd. · FXX · Aug 11, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K211552
• Device Name: Surgical mask
• Applicant: Shandong Shengquan New Materials Co., Ltd.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Aug 11, 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 surgical 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, and provided non-sterile.

Device Story

Surgical mask (Model SMDP20608) is a non-sterile, single-use, flat-pleated face mask. Construction consists of three layers: inner polypropylene spunbond, middle melt-blown polypropylene filter, and outer polypropylene spunbond (with carbon black colorant). Features include malleable polyethylene nose clip and spandex/polyester elastic ear loops. Used in clinical settings for infection control to provide barrier protection against blood, body fluids, and particulates. Device is worn by healthcare personnel and patients; provides physical barrier to reduce cross-contamination.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing including fluid resistance (ASTM F1862/F1862M-17), particulate filtration efficiency (ASTM F2299-03), bacterial filtration efficiency (ASTM F2101-19), differential pressure (EN 14683:2019), and flammability (16 CFR 1610). Biocompatibility testing (ISO 10993-5:2009, ISO 10993-10:2010) confirmed no cytotoxicity, irritation, or sensitization.

Technological Characteristics

Three-layer construction: polypropylene spunbond (inner/outer), melt-blown polypropylene (middle). Nose clip: malleable polyethylene. Ear loops: spandex/polyester. Dimensions: 17.5cm x 9.5cm. Meets ASTM F2100 Level 3. Biocompatibility per ISO 10993-5 and ISO 10993-10. Non-sterile, single-use.

Indications for Use

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

Regulatory Classification

Identification

Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.

Special Controls

*Classification.* (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible. (ii) Analysis and nonclinical testing must: (A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and (B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device. (iii) NIOSH approved under its regulation. (2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.

Predicate Devices

• Medical Face Mask (K201629)

Submission Summary (Full Text)

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August 11, 2021

Shandong Shengquan New Materials Co., Ltd. % Daniel Qiu Project Manager Shanghai Qisheng Business Consulting Co., Ltd. Room 1301, Bld 46, Jing Gu Zhong Rd. No.58, Min Hang District Shanghai, Shanghai 200240 China

Re: K211552

Trade/Device Name: Surgical mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: May 19, 2021 Received: May 19, 2021

Dear Daniel Qiu:

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, Ph.D. 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) K211552

Device Name Surgical mask

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 surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, and 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: K211552

#### I. Submitter

Shandong Shengquan New Materials Co.,Ltd. Diaozhen Industrial Development Zone, Zhangqiu District, Jinan, Shandong Province, China.

Telephone: [phone] Fax: [phone]

Contact person: Xiumei Zhang Date prepared: August 03,2021

#### II. Device

Name of Device: Surgical mask Model name: SMDP20608 Classification Name: surgical apparel (21 CFR 878.4040) Regulatory Class: II Product Code: FXX

#### III. Predicative device

510(k) Number: K201629 Name of Device: Medical Face Mask Classification Name: surgical apparel (21 CFR 878.4040) Regulatory Class: II Product code: FXX

#### IV. Device description

The Surgical Mask is a non-sterile, single use, and flat pleated mask with ear loops and nose clip. The product is manufactured with three layers, the inner layer is made of white polypropylene spunbond, the outer layer is made of black polypropylene spunbond (a common colorant named carbon black was added) and the middle layer is made of melt blown polypropylene filter. The elastic ear loops are not made with natural rubber latex. The nose clip in the layers of facemask is to allow the user

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to fit the facemask around their nose, which is made of malleable polyethylene wire. The mask will be provided in black and white. The colour of outer layer is black. The colour of inner layer is white.

### V. 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 surgical 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, and provided non-sterile.

| Item | Subject device | Predicate device | Discussion |
|----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product Namew | Surgical Mask | Medial Face Mask | |
| Manufacturer | Shandong Shengquan New<br>Materials Co., Ltd. | Shandong Shengquan<br>New Material Co., Ltd. | N/A |
| 510(k) number | K211552 | K201629 | N/A |
| Product code | FXX | FXX | Same |
| Regulation No. | 21 CFR878.4040 | 21 CFR878.4040 | Same |
| Class | Class II | Class II | Same |
| Intended use | The surgical masks are<br>intended to be worn to<br>protect both the patient<br>and healthcare personnel<br>from transfer of<br>microorganisms, body<br>fluids and particulate<br>material. These surgical<br>masks are intended for use<br>in infection control<br>practices to reduce the<br>potential exposure to<br>blood and body fluids. This<br>is a single use, disposable<br>device, and provided non-<br>sterile. | The medical face Masks<br>are intended to be worn<br>to protect both the<br>patient and healthcare<br>personnel from transfer of<br>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<br>blood and body fluids.<br>This is a single use,<br>disposable device, and<br>provided non-sterile. | Same |
| Model | Ear Loops. Flat Pleated. 3 | Ear Loops. Flat Pleated. 3 | Same |

#### VI. Comparison of technological characteristics with the predicate devices

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| | | layers | layers | |
|--------------------|--------------------------|------------------------------------|------------------------------------|-----------|
| Material | Outer layer | Polypropylene spunbond | Spunbond polypropylene | Same |
| | Middle<br>layer | Melt blown polypropylene<br>filter | Melt blown polypropylene<br>filter | Same |
| | Inner layer | Polypropylene spunbond | Spunbond polypropylene | Same |
| | Nose clip | Malleable polyethylene | Malleable polyethylene | Same |
| | Ear loops | Spandex, Polyester | Spandex, Polyester | Same |
| Color | | Black and White | White | Different |
| Dimension (Length) | | $17.5cm \pm 0.88cm$ | $17.5cm\pm0.88cm$ | Same |
| Dimension (Width) | | $9.5cm\pm0.48cm$ | $9.5cm\pm0.48cm$ | Same |
| OTC use | | Yes | Yes | Same |
| Sterility | | Non-sterile | Non-sterile | Same |
| Single-use | | Yes | Yes | Same |
| ASTM F2100 Level | | Level 3 | Level 2 | Different |
| Biocompatibility | In-vitro<br>cytotoxicity | Conform to ISO 10993-<br>5:2009 | Conform to ISO 10993-<br>05:2009 | Same |
| | Irritation | Conform to ISO 10993-<br>10:2010 | Conform to ISO 10993-<br>10:2010 | Same |
| | Skin<br>sensitization | Conform to ISO 10993-<br>10:2010 | Conform to ISO 10993-<br>10:2010 | Same |

The difference in the color and ASTM F2100 level does not raise additional questions for safety and effectiveness. Performance testing including biocompatibility evaluation was performed on the final finished device.

## VII. Summary of non-clinical testing

The test results demonstrated that the proposed device complies with the following standards:

- . ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity.
- . ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
- ASTM F2100-19, Standard Specification for Performance of Materials Used In . Medical Face Masks.
- . ASTM F1862M-17, Standard Test Method For Resistance Of Medical Face Masks To Penetration By Synthetic Blood (Horizontal Projection Of Fixed

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Volume At A Known Velocity).

- EN 14683:2019, Medical Face Mask-Requirements and Test Methods.
- . 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 F2299-03, Stand test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres.
- 16 CFR 1610, Standard for the Flammability of clothing textiles. .

| Performance<br>Characteristics | References for Test<br>Method | Acceptance Criteria | Results |
|---------------------------------------------------------|-------------------------------|----------------------------------|---------|
| Fluid Resistance<br>Performance<br>(mmHg) | ASTM<br>F1862/F1862M-17 | 29 out of 32 pass at<br>160 mmHg | Pass |
| Particulate Filtration<br>Efficiency (%) | ASTM F2299-03 | ≥ 98% | Pass |
| Bacterial Filtration<br>Efficiency (%) | ASTM F2101-19 | ≥ 98% | Pass |
| Differential Pressure<br>(Delta-P) Test (mm<br>H2O/cm2) | EN 14683:2019 | < 6 | Pass |
| Flammability | 16 CFR 1610 | Class I | Pass |

Table.1 Performance testing

#### Table.2 Biocompatibility Testing

| ltem | Test method | Results |
|--------------------------|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| In vitro<br>cytotoxicity | ISO 10993-5:2009 | Under the conditions of this study, the test article<br>extract did not show potential toxicity to L-929 cells. |
| Irritation | ISO 10993-<br>10:2010 | The test result showed that the extract of applied<br>sample did not induce skin irritation in rabbit skin. |
| Skin<br>sensitization | ISO 10993-<br>10:2010 | Under the conditions of this study, the test article<br>extract showed no significant evidence of causing skin<br>sensitization in the guinea pig. |

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#### VIII. Summary of clinical testing

Clinical testing was not required to demonstrate the substantial equivalence of Shengquan Surgical Mask to its predicate device.

#### 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 demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.