JianYu Surgical Mask

K201754 · Jiangsu Jianyu Health Medical Co., Ltd. · FXX · Dec 30, 2020 · General, Plastic Surgery

Device Facts

• Record ID: K201754
• Device Name: JianYu Surgical Mask
• Applicant: Jiangsu Jianyu Health Medical Co., Ltd.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Dec 30, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

JianYu surgical mask is intended to be worn to protect both patients and healthcare workers from transfer of microorganisms, body fluids, and particulate material. The surgical mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. The JianYu surgical mask is a single use, disposable device provided non-sterile.

Device Story

JianYu Surgical Mask; 3-layer flat-pleated disposable device; outer/inner layers spunbond polypropylene; filter layer meltblown polypropylene; ear loops; malleable nosepiece. Used in clinical settings for infection control; worn by healthcare personnel and patients. Provides physical barrier against microorganisms, body fluids, and particulates; reduces potential exposure to blood/fluids. Non-sterile; single-use.

Clinical Evidence

No clinical data. Bench testing only. Device met ASTM F2100-19 Level 3 criteria: BFE ≥99.9% (ASTM F2101), PFE ≥98% (ASTM F2299), synthetic blood penetration resistance at 160mmHg (ASTM F1862), and Class 1 flammability (16CFR Part 1610). Biocompatibility testing per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation/sensitization) showed no adverse reactions.

Technological Characteristics

3-layer flat-pleated mask; spunbond/meltblown polypropylene construction; spandex ear loops; malleable aluminum/PVC nosepiece. Dimensions 175x95mm. Non-sterile. Performance meets ASTM F2100-19 Level 3. Biocompatibility per ISO 10993-1, 10993-5, 10993-10.

Indications for Use

Indicated for patients and healthcare workers 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

• Surgical Face Mask (EL30000) (K160269)

Submission Summary (Full Text)

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December 30, 2020

Jiangsu JianYu Health Medical Co., Ltd. Andy Shu Regulatory Affairs Specialist No. 88 Longxi Avenue, Zhulin Town, Jintan District Changzhou, Jiangsu 213241 China

Re: K201754

Trade/Device Name: JianYu Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: December 16, 2020 Received: December 29, 2020

#### Dear Andy Shu:

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 (OS) 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)

K201754

Device Name

JianYu Surgical Mask

Indications for Use (Describe)

Jian Yu surgical mask is intended to be worn to protect both patients and healthcare workers from transfer of microorganisms, body fluids, and particulate material. The surgical mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. The JianYu surgical mask 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

(as requested by 21 CFR 807.92)

| 510K Number: | K201754 |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter / 510(k) owner: | Jiangsu JianYu Health Medical Co., Ltd.<br>Address: No. 88 Longxi Avenue, Zhulin Town, Jintan District,<br>Changzhou City, Jiangsu, CN 213241<br>Tel: [phone]<br>Fax: [phone] |
| Contact Person: | Andy Shu<br>Regulatory Affairs Specialist<br>E-mail: [e-mail] |
| Date of preparation: | June 15th, 2020 |
| Proposed device: | |
| Trade Name: | JianYu Surgical Mask |
| Common/Classification Name: | Surgical Mask Regulation |
| Name: | Surgical Apparel |
| Product Code: | FXX |
| Review Panel: | General Hospital |
| Device Class: | Class II |
| Regulation Number: | 878.4040 |
| Legally Marketed Predicate Device: | |
| Trade Name: | Surgical Face Mask (EL30000) |
| 510(k) Number: | K160269 |
| Submitter of 510(k)/holder: | SAN-M PACKAGE CO., LTD. |

#### Device Description:

The JianYu surgical mask is composed of 3-layers and is flat-pleated. The mask materials consist of an outer layer (spunbond polypropylene, blue), filter layer (meltblown polypropylene, white), and inner layer (spunbond polypropylene, white). The three layers of the mask body are collated and sonically welded around the edges. The surgical mask contains ear loops attached by welding to secure the mask over the user's mouth and face and includes a malleable nosepiece to provide a firm fit over the nose. The surgical mask is a single use, disposable device, provided non-sterile.

#### Intended Use:

JianYu surgical mask is intended to be worn to protect both patients and healthcare workers from transfer of microorganisms, body fluids, and particulate material. The surgical mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. The JianYu surgical mask is a single use, disposable device provided non-sterile.

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# Comparison of Technological Characteristics between the subject and predicate devices:

JianYu Surgical mask has the same technological characteristics as the predicate device. The design, material, form, fit, function and method of operation are similar.

| Element of<br>Comparison | Subject Device<br>K201754 | Predicate Device<br>K160269 | Comparison |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for<br>Use | JianYu surgical mask is intended to<br>be worn to protect both patients and<br>healthcare workers from transfer of<br>microorganisms, body fluids, and<br>particulate material. The surgical<br>mask is intended for use in infection<br>control practices to reduce the<br>potential exposure to blood and body<br>fluids. The JianYu surgical mask is a<br>single use, disposable device<br>provided non-sterile. | The surgical face masks are<br>intended to be worn to protect both<br>the 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<br>single-use, disposable device,<br>provided non-sterile. | Same |
| Material<br>Composition | Three-layer mask constructed of:<br>Outer layer: spunbond polypropylene<br>Filter layer: meltblown polypropylene<br>Inner layer: spunbond polypropylene<br>Ear loops: spandex<br>Nose clip: malleable aluminum<br>wire/PVC | Outer layer: Polypropylene<br>Filter media:<br>1. Polypropylene spunbond<br>2. Polypropylene meltblown Inner<br>layer: Polypropylene<br>Ear loop: Polyester, polyurethane<br>Nose lamps: Polyethylene coated<br>steel wire | Similar |
| Dimension | Length: 175±5mm, Width: 95±5mm | Length: 175±5mm, Width: 90±3mm | Similar |
| Mask style | Flat-pleated | Flat-pleated | Same |
| Design feature | Ear loops | Ear loops | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single use; Disposable | Single use; Disposable | Same |
| Color | Blue | White or blue | Same |
| Biocompatibility | The surgical mask was tested with<br>following standards:<br>• AAMI /ANSI/ ISO<br>10993-5:2009,<br>Under the testing conditions, the<br>subject surgical mask did not show<br>potential cytotoxicity<br>• AAMI /ANSI/ ISO<br>10993-10:2010,<br>Under the testing conditions, the<br>subject surgical mask did not cause<br>significant irritation or sensitization<br>reaction to the test animals | The surgical mask was tested in<br>accordance with ISO10993 and<br>passed acceptance<br>criteria. | Same |

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| Product performance specification per ASTM F2100-19 meets Level 3 | | | | |
|-------------------------------------------------------------------|----------------------------------------------------|--------------------------------------------------|------------------------------------------|------------------------------|
| | | | | |
| Bacterial<br>filtration<br>efficiency<br>(BFE) | Passed at ≥99.9% ASTM F2101 | Passed at ≥99% ASTM F2101 | Same | |
| | Differential<br>pressure | Passed at <6.0 mmH2O/cm²<br>EN14683:2019 Annex C | Passed at 2.5 mmH2O/cm² MIL-<br>M-36954C | Similar |
| | | Particulate filtration<br>efficiency (PFE) | Passed at ≥98% ASTM F2299 | Passed at 99.7% ASTM F2299 |
| | Resistance to<br>penetration by<br>synthetic blood | | Passed at 160mmHg ASTM F1862 | Passed at 160mmHg ASTM F1862 |
| Flammability | | | Class 1, 16CFR PART 1610 | Class 1, 16CFR PART 1610 |

## Summary of Non-Clinical Performance Testing

Performance tests have been conducted on Surgical mask per ASTM F2100-19, and all testing results met ASTM F2100-19 Level 3 acceptance criteria. Detailed testing conducted as below:

- Bacterial filtration efficiency (BFE) •
- Differential pressure
- Particulate filtration efficiency (PFE) •
- Resistance to penetration by synthetic blood •
- Flammability •

### Testing standards

| Standards No. | Standards Title |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ASTM F2100-19 | Standard Specification for Performance of Materials Used in<br>Medical Face Masks |
| ASTM F2101-19 | Standard Test Method for Evaluating the Bacteria Filtration Efficiency (BFE)<br>of Medical Face Mask Materials, Using a<br>Biological Aerosol of Staphylococcus Aureus |
| EN14683: 2019 | Medical Fask Masks—Requirements and Test Methods |
| ASTM F2299-17 | Standard Test Method for Determining the Initial Efficiency of<br>Materials Used in Medical Face Masks to Penetration by<br>Particulates Using Latex Spheres |
| F1862/F1862M-17 | Standard Test Method for Resistance of Medical Face Masks to Penetration<br>by Synthetic Blood (Horizontal Projection of Fixed<br>Volume at a Known Velocity) |
| 16CFR PART 1610 | Standard for the Flammability of Clothing Textiles |
| ISO 10993-1:2018 | Biological evaluation of medical devices - Part 1: Evaluation and<br>testing within a risk management process |
| AAMI /ANSI/ ISO<br>10993-10:2010 | Biological evaluation of medical devices - Part 10: Tests for<br>irritation and skin sensitization |
| AAMI /ANSI/ ISO<br>10993-5:2009 | Biological evaluation of medical devices - Part 5: Tests for in<br>vitro cytotoxicity |

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#### Summary of Clinical Performance Testing

Not applicable.

#### Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K201754, the JianYu Surgical Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K160269.