Surgical face mask

K203704 · Juntech(Jiaxing)Healthcare Materials Co,.Ltd · FXX · Jun 4, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K203704
• Device Name: Surgical face mask
• Applicant: Juntech(Jiaxing)Healthcare Materials Co,.Ltd
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Jun 4, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

Surgical Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.

Device Story

Surgical Face Mask is a single-use, multi-layer, flat-pleated mask. Construction includes an outer and inner layer of spun-bond polypropylene sandwiching a meltblown polypropylene filter. Features urethane elastic earloops and a steel wire nosepiece covered in polypropylene. Device is used in clinical settings (operating rooms, general healthcare) by personnel to provide a barrier against microorganisms, blood, body fluids, and particulates. It functions as a physical barrier; performance meets ASTM F2100-19 Level 3 requirements. Benefits include reduced risk of cross-contamination between patients and healthcare workers.

Clinical Evidence

Bench testing only. Performance evaluated against ASTM F2100-19 standards for Level 3 classification. Testing included fluid resistance (160 mmHg), particle filtration efficiency (>99.9% at 0.1µm), bacterial filtration efficiency (>99.9%), flammability (Class 1), and differential pressure (3.7–4.6 mmH2O/cm2). Biocompatibility confirmed per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and sensitization).

Technological Characteristics

Materials: Spun-bond polypropylene, meltblown polypropylene, urethane elastic fiber, steel wire with PP covering. Form factor: Flat-pleated mask with earloops, 17.5cm x 9cm. Performance: ASTM F2100-19 Level 3. Biocompatibility: ISO 10993-1 compliant. Single-use, non-sterile.

Indications for Use

Indicated for use by operating room personnel and general healthcare workers to protect patients and staff from transfer of microorganisms, blood, body fluids, and particulates.

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

• Face Mask, Surgical Mask, Surgical Face Mask (K173062)

Submission Summary (Full Text)

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June 4, 2021

Juntech(Jiaxing)Healthcare Materials Co,.Ltd % Gamma Zhang RA Manager Feiying Drug&Medical Consulting Technical Service Group Rm 218, Building 2, Yike Intelligent Innovation Park, No. 232 Kezhu Road, Huangpu, Guangzhou Guangzhou, Guangdong 510000 China

Re: K203704

Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 28, 2021 Received: May 5, 2021

Dear Gamma Zhang:

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.

Ryan Ortega, Ph.D. 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) K203704

Device Name Surgical Face Mask

Indications for Use (Describe)

Surgical Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.

| 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 submitted in accordance with requirements of Title 21, CFR Section 807.92.

#### (1) Applicant information

| 510 (k) owner's name: | Juntech (Jiaxing) Healthcare Materials Co,.Ltd |
|---------------------------|---------------------------------------------------------------------------------------------------------------------|
| Address: | No.4 Plant, No1 build of North of Yubei St, and Zhengdong Rd,<br>Yuxin Town Nanhu District, Jiaxing Zhejiang, China |
| Contact person: | Cam Sun |
| Phone number: | 86-573-83178618 |
| Fax number: | 86-573-83178620 |
| Email: | [e-mail] |
| Date of summary prepared: | 2021-04-27 |

#### (2) Proprietary name of the device

| Trade name: | Surgical Face Mask |
|--------------------|---------------------------|
| Regulation name: | Surgical apparel |
| Regulation number: | 21 CFR 878.4040 |
| Product code: | FXX |
| Review panel: | General & Plastic Surgery |
| Regulation class: | Class II |

#### (3) Predicate device

| Sponsor | V&Q Manufacturing Corporation |
|-------------------|----------------------------------------------|
| Device Name | Face Mask, Surgical Mask, Surgical Face Mask |
| 510(k) Number | K173062 |
| Product Code | FXX |
| Regulation Number | 21 CFR 878.4040 |
| Regulation Class | II |

### (4) Description/ Design of device

Surgical Face Mask is single use multi-layer mask with outer layer and inner layer (spun-bond polypropylene) that sandwich a meltblown polypropylene filter material. Earloops are of urethane elastic fiber and not made with natural rubber latex; The nose piece is a white aluminum strip covered by PP covering. All of the materials used in the construction of the surgical mask are being used in currently marketed devices.

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# (5) Indications for use

Surgical Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.

#### (6) Materials

| Component of | Material of | Body Contact Category<br>(ISO 10993-1) | Contact Duration (ISO<br>10993-1) |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|------------------------------------------|
| Device Requiring | Component | | |
| Biocompatibility | | | |
| Surgical Face Mask | Spunbond<br>polypropylene,<br>meltblown<br>polypropylene,<br>urethane elastic<br>fiber, Steel wire<br>covered by PP<br>covering. | Surface-contacting<br>device: skin | Prolonged contact: 24 hours<br>to 30 day |

The body-contacting material used in the Surgical Face Mask have all passed biocompatibility test. Details can be seen in "Biocompatibility Discussion".

## (7) Technological Characteristics Comparison Table

| Item | Subject device | Predicate device | Comparison |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Trade name | Surgical Face Mask | Non Woven Face Mask | / |
| 510 (k) number | K203704 | K173062 | / |
| Regulation number | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Regulation description | Surgical apparel | Surgical apparel | Same |
| Product code | FXX | FXX | Same |
| Class | II | II | Same |
| Indications for use/ Intended use | Surgical Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood | Non Woven Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against | Same |

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| | | and body fluids, and | transfer of | | |
|-------------------------------------------|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | | particulate materials. | microorganisms,<br>blood and body fluids,<br>and<br>particulate materials. | | |
| | Inner<br>layer | Spun-bond<br>polypropylene | Spun-bond<br>polypropylene | Similar. All the materials of<br>Targeted device are used in<br>Predicate device. | |
| | Middle<br>layer | Meltblown<br>polypropylene | Meltblown<br>polypropylene | | |
| Materials | Outer<br>layer | Spun-bond<br>polypropylene | Spun-bond<br>polypropylene | | |
| | Nosepiece | Steel wire covered by<br>PP covering | White aluminum strip<br>with PP covering | | |
| | Headband | Urethane elastic fiber | Urethane elastic fiber<br>or spun-bond<br>polypropylene | | |
| Mask style | | Flat pleated | Flat pleated | Same | |
| Design feature | | Earloop | Earloop or tie-on | Same | |
| Dimensions | | 17.5cm*9cm | 175mm×95mm | Same | |
| Latex | | Not made with natural<br>rubber latex | Not made with natural<br>rubber latex | Same | |
| Color | | Blue (outer layer) and<br>white (inner layer) | Blue (outer layer) and<br>white (inner layer) | Same | |
| Performance test result | | | | | |
| Performance<br>Testing (ASTM<br>F2100-19) | | Level 3 | Level 2 | Different. Note 1 | |
| Fluid resistance | | 3 non-consecutive lots,<br>1st lot: 30 of 32<br>samples >99.9% at 0.1µm<br>pass at 160 mmHg;<br>2nd lot: 29 of 32 samples<br>pass at 160mmHg;<br>3rd lot: 29 of 32<br>samples >99.9% at 0.1µm<br>pass at 160mmHg | Pass at 120 mmHg | Similar. Targeted device meets<br>ASTM F2100-19<br>Requirements for Level<br>3 Classification and ISO 22609:<br>≥29 of 32 test articles pass at<br>160 mmHg | |
| Particle Filtration<br>Efficiency | | 3 non-consecutive lots,<br>1st lot: 32<br>samples >99.9% at<br>0.1 μm; | Average 99.74%<br>at 0.1 µm | Similar. Targeted device meets<br>ASTM F2100-19<br>Requirements for Level<br>3 Classification: ≥98% at 0.1µm | |

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| | samples >99.9% at<br>0.1μm;<br>3rd lot: 32<br>samples >99.9% at 0.1µm | | |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Bacterial<br>Filtration<br>Efficiency | 3 non-consecutive lots,<br>1st lot: 32<br>samples >99.9%;<br>2nd lot: 32<br>samples >99.9%;<br>3rd lot: 32<br>samples >99.9% | 99.4% | Similar. Targeted device meets<br>ASTM F2100-19<br>Requirements for Level<br>3 Classification: ≥98% |
| Flammability<br>Class | 3 non-consecutive lots,<br>Each lot: 32 samples:<br>Class 1 | Class 1 | Similar. Targeted device meets<br>ASTM F2100-19<br>Requirements for Level<br>3 Classification: Class 1 |
| Delta – P | 3 non-consecutive lots,<br>1st lot: 4.1 to 4.5 mmH2O/cm2;<br>2nd lot: 4.0 to 4.6 mmH2O/cm2;<br>3rd lot: 3.7 to 3.9 mmH2O/cm2 | Average mmH2O/cm2 | 2.7 Similar. Targeted device meets<br>ASTM F2100-19<br>Requirements for Level<br>3 Classification: <6 mmH2O/cm2 |
| Biocompatibility | Under the conditions of<br>the study, the device<br>was found non-<br>cytotoxic", "non-<br>irritating", or<br>"non-sensitizing | Under the conditions<br>of the study, the<br>device was found<br>non-cytotoxic",<br>"non-irritating", or<br>"non-sensitizing | Same |

#### A Note 1:

The surgical masks are divided into three levels against ASTM F2100-19 which Level 3 Barrier is the most demanding. Performance testing was provided in support of that the Surgical Face Mask meets ASTM F2100-19 Requirements for Level 3 Classification.

#### (8) Summary for Non-clinical Studies

The performance tests of Non Woven Face Mask were conducted.

- A 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 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 ASTM F 2101-14 Standard Test Method For Evaluating The Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus.

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Juntech (Jiaxing) Healthcare Materials Co,. Ltd - K203704

- > MIL-M-36954C Military Specification - Mask, Surgical, Disposable
- 16 CFR Part 1610 STANDARD FOR THE FLAMMABILITY OF CLOTHING TEXTILES >

During use, the Non Woven Face Mask will directly contact with user's skin, so we have it tested to demonstrate conformance to the following standards.

- A ISO 10993-5, Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- > ISO 10993-10, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization

| Test Methodology | Purpose | Acceptance<br>Criteria | Results | |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Testing<br>(ASTM<br>F2100-19) | To test the fluid<br>resistance, particle<br>filtration efficiency,<br>bacterial filtration<br>efficiency, flammability<br>class, Differential<br>Pressure of Surgical Face<br>Mask | Level 3 | Level 3 | |
| Fluid resistance | To evaluate surgical<br>facemasks and other types<br>of protective clothing<br>materials designed to<br>protect against fluid<br>penetration, as well as<br>simulate an arterial spray<br>and evaluate the<br>effectiveness of the test<br>article in protecting the<br>user from possible<br>exposure to blood and<br>other body fluids. | Per ASTM F1862<br>and ISO 22609, an<br>acceptable quality<br>limit of 4.0% is<br>met for a normal<br>single<br>sampling plan<br>when ≥29 of 32<br>test articles show<br>passing results. | 3 non-consecutive lots,<br>1st lot: 30 of 32 samples<br>>99.9% at 0.1μm pass at<br>160 mmHg;<br>2nd lot: 29 of 32 samples<br>pass at 160mmHg;<br>3rd lot: 29 of 32 samples<br>>99.9% at 0.1μm pass at<br>160mmHg | |
| Particle Filtration<br>Efficiency | To evaluate the non-viable<br>particle filtration<br>efficiency (PFE) of the<br>test article | ≥98% at 0.1μm | 3 non-consecutive lots,<br>1st lot: 32 samples<br>>99.9% at 0.1μm;<br>2nd lot: 32 samples<br>>99.9% at 0.1μm;<br>3rd lot: 32 samples<br>>99.9% at 0.1μm | |
| Bacterial Filtration<br>Efficiency | To determine the filtration<br>efficiency of test articles<br>by comparing<br>the bacterial control<br>counts upstream of the<br>test article to the bacterial<br>counts downstream. | ≥98% | 3 non-consecutive lots,<br>1st lot: 32 samples<br>>99.9% at 0.1μm;<br>2nd lot: 32 samples<br>>99.9% at 0.1μm;<br>3rd lot: 32 samples<br>>99.9% at 0.1μm | |
| Flammability Class | To evaluate the<br>flammability of plain<br>surface clothing textiles<br>by measuring the ease of<br>ignition and the speed of<br>flame spread. | Class 1 | 3 non-consecutive lots,<br>Each lot: 32 samples:<br>Class 1 | |
| Delta - P | To determine the | <6 mmH2O/cm2 | 3 non-consecutive lots, | |
| Biocompatibility<br>ISO 10993-5 and ISO<br>10993-10 | breathability of test<br>articles by measuring the<br>differential air pressure on<br>either side of the test<br>article using a manometer,<br>at a constant flow rate. | To test In Vitro<br>Cytotoxicity, Irritation<br>and Skin Sensitization of<br>Surgical Medical Mask | non-cytotoxic",<br>"non-irritating", or<br>“non-sensitizing | 1st lot: 4.1 to 4.5 mmH2O/cm2;<br>2nd lot: 4.0 to 4.6 mmH2O/cm2;<br>3rd lot: 3.7 to 3.9 mmH2O/cm2<br>Under the conditions of<br>the study, the device was<br>found non-cytotoxic",<br>"non-irritating", or<br>"non-sensitizing |

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## (9) Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K203704, Surgical Face Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K173062.