Surgical Face Mask

K211899 · Hubei Yi-Ya Protective Products Co., Ltd. · FXX · Oct 4, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K211899
• Device Name: Surgical Face Mask
• Applicant: Hubei Yi-Ya Protective Products Co., Ltd.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Oct 4, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The 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. They 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.

Device Story

Surgical face mask; three-layer, flat-pleated design; ear loops; nose piece. Input: physical barrier to microorganisms, body fluids, and particulates. Operation: mechanical filtration via spun-bond polypropylene outer/inner layers and melt-blown polypropylene filter layer. Output: physical protection for wearer and patient. Used in clinical settings for infection control. Healthcare providers wear the mask to reduce exposure to blood and body fluids. Benefits: reduced risk of cross-contamination and exposure to infectious agents.

Clinical Evidence

No clinical data. Bench testing only. Testing included fluid resistance (ASTM F1862), particulate filtration efficiency (ASTM F2299), bacterial filtration efficiency (ASTM F2101), differential pressure, flammability (16 CFR 1610), and biocompatibility (ISO 10993-5, ISO 10993-10). All tests met ASTM F2100 Level 2 and 3 requirements.

Technological Characteristics

Three-layer, flat-pleated mask. Materials: Spun-bond polypropylene (inner/outer), melt-blown polypropylene (filter), iron bar coated with polyolefin (nose wire), spandex (ear loops). Dimensions: 17.5cm x 9.5cm. Non-sterile, single-use. Complies with ASTM F2100, ASTM F1862, ASTM F2101, ASTM F2299, ISO 10993-5/10, and 16 CFR 1610.

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 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

• Surgical Face Mask (K182515)

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). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

October 4, 2021

Hubei YI-YA PROTECTIVE PRODUCTS CO., LTD % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China

Re: K211899

Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: August 8, 2021 Received: August 30, 2021

Dear Ivy Wang:

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,

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 Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K211899

Device Name Surgical Face Mask

#### Indications for Use (Describe)

The 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. They are 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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# 510(K) Summary

### K211899

Date prepared: 2021-10-01

#### A. Applicant:

Hubei YI-YA PROTECTIVE PRODUCTS CO., LTD Address: Miandong Road,Hefeng Village, Xiliuhe Town, Xiantao City, Hubei Province, China Contact person: Feng Xiang Title: Legal Representative Tel: + 86-18771150610 Fax: + 86-0728-3326822 Email: [e-mail]

Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: [phone] Email: [e-mail] Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: [phone] Email: [e-mail]

#### B. Device:

Trade Name: Surgical Face Mask Common Name: SURGICAL MASK Model: Ear Loops

Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel

#### C. Predicate device:

K182515 Surgical Face Mask Wuhan Dymex Healthcare Co., Ltd.

#### D. Indications for use of the device:

The Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from

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transfer of microorganisms, body fluids and particulate material. They 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.

### E. Device Description:

The Surgical Face Masks are blue color, single use, three-layer, flat-folded masks with nose piece and ear loops. The blue colorant is polypropylene (PP) master batch.

The Surgical Face Masks are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.

The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex.

The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of iron bar coated with Polyolefin.

The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.

The proposed device will be provided in two models of level 3. The two models are totally the same, only distinguished by level 2 & level 3 for business purpose.

### F. Technological Characteristic Comparison

| Device | | Proposed Device | Predicate Device | Comparision |
|----------------|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| 510K # | | K211899 | K182515 | - |
| Manufacturer | | Hubei YI-YA PROTECTIVE PRODUCTS<br>CO., LTD | Wuhan Dymex Healthcare Co., Ltd. | - |
| Model Name | | SURGICAL FACE MASK<br>Ear loops | SURGICAL FACE MASK<br>Ear loops | Same |
| Classification | | Class II Device, FXX (21 CFR878.4040) | Class II Device, FXX (21 CFR878.4040) | Same |
| Intend use | | The Surgical Face Masks are intended<br>to be worn to protect both the<br>patient and healthcare personnel<br>from transfer of microorganisms,<br>body fluids and particulate material.<br>They are intended for use in infection<br>control practices to reduce the<br>potential exposure to blood and<br>body fluids. This is a single use,<br>disposable device(s), provided<br>non-sterile. | The Surgical Face Masks are intended<br>to be worn to protect both the<br>patient and healthcare personnel<br>from transfer of microorganisms,<br>body fluids and particulate material.<br>These face masks are intended for<br>use in infection control practices to<br>reduce the potential exposure to<br>blood and body fluids. This is a single<br>use, disposable device(s), provided<br>non-sterile. | Same |
| Materials | Design Features | Ear Loops, Flat-pleated, 3 layers | Ear Loops, Flat-pleated, 3 layers | Same |
| | Outer<br>layer | Spunbond Polypropylene | Spunbond Polypropylene | Same |
| | Inner layer | Spunbond Polypropylene | Spunbond Polypropylene | Same |
| | Filter layer | Melt-blown Polypropylene | Melt-blown Polypropylene | Same |
| | Nose wire | iron bar coated with polyolefin | Malleable polyethylene wire | Different |
| | Ear loops | Spandex | Spandex | Same |

## Table 1 General Comparison

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| Color | Blue | Yellow | Different |
|-----------------------|------------------------|------------------------|-----------|
| Dimension<br>(Length) | $17.5cm\pm0.2cm$ | $17.5cm\pm0.2cm$ | Same |
| Dimension<br>(Width) | $9.5cm\pm0.2cm$ | $9.5cm\pm0.2cm$ | Same |
| OTC use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| ASTM F2100<br>Level | Level 2 & 3 | Level 2 | Similar |

## G. Summary of Non-Clinical Test

Non-clinical tests were conducted using 3 nonconsecutive lots with 32 samples for each model of surgical mask to verify that the proposed device met all design specifications as was same to the predicate device. The test results demonstrated that the proposed device complies with the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submission issued on March 5, 2004:

- A ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- A ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
- > ASTM F2100, Standard Specification for Performance of Materials Used In Medical Face Masks
- > ASTM F1862, Standard Test Method for Resistance of Medical Face Masks To Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume At A Known Velocity);
- A EN 14683, Medical Face Masks—Requirements and Test Methods;
- A ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol of Staphylococcus Aureus;
- > ASTM F2299, Standard test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres;
- A 16 CFR 1610, Standard for the Flammability of clothing textiles;

| Test Methodology | Purpose | Acceptance Criteria:<br>ASTM F2100 Level 2 & 3 | Result |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Fluid Resistance | The purpose of the test is to<br>evaluate the Resistance to<br>penetration by synthetic blood,<br>Minimum pressure in mmHg | 29 out of 32 pass at 120<br>mmHg for level 2<br>29 out of 32 pass at 160<br>mmHg for level 3 | PASS<br>32 out of 32 pass at<br>160 mmHg for level 2 &<br>3 |
| Particulate Filtration<br>Efficiency | The purpose of the test is to<br>evaluate the Sub-micron<br>particulate filtration efficiency<br>at 0.1 micron, % (PFE) | ≥ 98% | PASS<br>98.7%; 98.72%; 99.28% |
| Bacterial Filtration<br>Efficiency | The purpose of the test is to<br>evaluate the Bacterial filtration<br>efficiency (BFE) (%) | ≥ 98% | PASS<br>99.88%; 99.89%;<br>99.83% |
| Differential Pressure | The purpose of the test is to | < 6.0mmH2O/cm² | PASS |

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| | evaluate the Different pressure<br>(Delta-P) | | 3.94mmH2O/cm²;<br>4.01mmH2O/cm²;<br>3.55mmH2O/cm² |
|---------------|----------------------------------------------------------------------------------------------------------|-----------------|--------------------------------------------------------------------------------|
| Flammability | The purpose of the test is to<br>evaluate the Flame spread | Class 1 | PASS<br>Class 1 |
| Cytotoxicity | The purpose of the testing is to<br>demonstrate the<br>biocompatibility safety of the<br>subject device. | Non-cytotoxic | PASS<br>Under the conditions of<br>the study, the device is<br>non-cytotoxic. |
| Irritation | The purpose of the testing is to<br>demonstrate the<br>biocompatibility safety of the<br>subject device. | Non-irritating | PASS<br>Under the conditions of<br>the study, the device is<br>non-irritating. |
| Sensitization | The purpose of the testing is to<br>demonstrate the<br>biocompatibility safety of the<br>subject device. | Non-sensitizing | PASS<br>Under the conditions of<br>the study, the device is<br>non-sensitizing |

## H. Summary of Clinical Test Conclusion

No clinical study is included in this submission.

#### l. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device K182515.