Disposable Medical Mask

K203112 · Yangzhou Runyi Arts & Crafts Co., Ltd. · FXX · Sep 16, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K203112
• Device Name: Disposable Medical Mask
• Applicant: Yangzhou Runyi Arts & Crafts Co., Ltd.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Sep 16, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The Disposable Medical 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.

Device Story

Disposable, 3-layer, flat-pleated surgical mask; intended for infection control. Input: physical barrier against microorganisms, body fluids, and particulates. Operation: mechanical filtration via melt-blown polypropylene layer; ear loops (nylon/spandex) and polyethylene nose piece secure mask to user face. Output: physical protection for patient and healthcare personnel. Used in clinical settings; operated by healthcare personnel or patients. Benefits: reduces potential exposure to blood and body fluids.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against ASTM F1862 (synthetic blood penetration), ASTM F2299 (particulate filtration), ASTM F2101 (bacterial filtration), MIL-M-36954 (differential pressure), and 16 CFR 1610 (flammability). Biocompatibility confirmed via ISO 10993-5 and ISO 10993-10.

Technological Characteristics

3-layer construction: outer/inner layers spunbond polypropylene, middle layer melt-blown polypropylene filter. Nose piece: polyethylene. Ear loops: nylon/spandex. Dimensions: 14 cm x 9 cm. Non-sterile, single-use. Meets ASTM F2100 Level 2 requirements.

Indications for Use

Indicated for use by healthcare personnel and patients to reduce exposure to microorganisms, body fluids, and particulate material in infection control settings. Single-use, non-sterile, disposable device.

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

• Single-use Medical Face Mask (K203591)

Submission Summary (Full Text)

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September 16, 2021

Yangzhou Runyi Arts & Crafts CO., LTD. % Helen Nan General Manager Wenzhou Cytech Information Service Co., Ltd. Room302, Building3, Hangqian Mansion, Hangqian Street, Lucheng District Wenzhou, Zhejiang 32500 China

Re: K203112

Trade/Device Name: Disposable Medical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: September 13, 2021 Received: September 13, 2021

Dear Helen Nan:

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. Liqun Zhao -S

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) K203112

Device Name Disposable Medical Mask

Indications for Use (Describe)

The Disposable Medical 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.

| Type of Use (Select one or both, as applicable) | <table style="border:none;"><tr><td><div style="display:inline-block; vertical-align:middle;"><input type="checkbox"/></div>Prescription Use (Part 21 CFR 201 Subpart D)</td><td><div style="display:inline-block; vertical-align:middle;"><input checked="" type="checkbox"/></div>Over-The-Counter Use (21 CFR 201 Subpart C)</td></tr></table> | <div style="display:inline-block; vertical-align:middle;"><input type="checkbox"/></div> Prescription Use (Part 21 CFR 201 Subpart D) | <div style="display:inline-block; vertical-align:middle;"><input checked="" type="checkbox"/></div> Over-The-Counter Use (21 CFR 201 Subpart C) |
|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:inline-block; vertical-align:middle;"><input type="checkbox"/></div> Prescription Use (Part 21 CFR 201 Subpart D) | <div style="display:inline-block; vertical-align:middle;"><input checked="" type="checkbox"/></div> Over-The-Counter Use (21 CFR 201 Subpart C) | | |

|_ | Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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### YANGZHOU RUNYI ARTS & CRAFTS CO., LTD.

### K203112 510(k) Summary (As required by 21 CFR 807.92)

#### 1.0 Submitter Information

| Company: | YANGZHOU RUNYI ARTS & CRAFTS CO., LTD. |
|-------------------------------------------|---------------------------------------------------------------------------|
| Address: | 4.NO.87 West Heye Road HanJiang District<br>Yangzhou,Jiangsu,225008,CHINA |
| Phone: | 086-514-82082789 |
| Contact Person: | Li Yu |
| Title: | Legal Person |
| E-mail: | [e-mail] |
| • Date of Preparation: September 15, 2021 | |

#### 2.0 Device Information

| Trade/Device Name: | Disposable Medical Mask |
|-------------------------|-------------------------|
| Model: | RYSM001 |
| Regulation Description: | Surgical apparel |
| Device: | Mask, Surgical |
| Review Panel: | General Hospital |
| Product Code: | FXX |
| Regulation Number: | 21 CFR 878.4040 |
| Device Class: | Class II |

### 3.0 Predicate Device Information

| Trade/Device Name: | Single-use Medical Face Mask |
|--------------------|------------------------------|
| 510k Number: | K203591 |
| Submitter: | Conod Medical Co., Limited |

### 4.0 Device Description

The Disposable Medical Masks are non-sterile, single use, 3 layers, flat-pleated style surgical masks. Each mask contains ear loops made of nylon and spandex to secure the mask over the user's face and mouth with nose piece made of polypropylene to firmly fit over the nose. The size of the mask body is 14 cm×9 cm and the dimension of the ear loop is 8 cm × 0.3 cm, the dimension of nose piece is 9.4 cm×0.3 cm. The outer layer and inner facing layer of face mask consists of Spunbond Polypropylene. Color of the inner facing layer of the mask is white and color of the outer facing layer is blue. The middle layer consists of white Melt Blown Polypropylene Filter.

50 masks are packed in a polyethylene plastic bag and placed in the package box made of white cardboard. Outside the package box there is also a PE plastic film cover on the box. This device is not made from any natural rubber latex.

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## YANGZHOU RUNYI ARTS & CRAFTS CO., LTD.

### 5.0 Indications for Use

The Disposable Medical 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.

| Device | Predicate Device | Proposed Device | Compariso<br>n |
|----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Manufacturer | Conod Medical Co.,<br>Limited | YANGZHOU RUNYI<br>ARTS & CRAFTS<br>CO., LTD. | N/A |
| 510K Number | K203591 | K203112 | N/A |
| Trade/Device<br>Name | Single-use Medical<br>Face Mask | Disposable Medical<br>Mask | N/A |
| Product Code | FXX | FXX | Same |
| Classification | Class II<br>(21 CFR 878.4040) | Class II<br>(21 CFR 878.4040) | Same |
| Indications<br>for Use | The Single-use<br>Medical Face Masks<br>are intended to be<br>worn to protect both<br>the patient and<br>healthcare personnel<br>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(s),<br>provided non-sterile. | The Disposable<br>Medical Masks are<br>intended to be worn to<br>protect both the patient<br>and<br>healthcare<br>personnel<br>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(s),<br>provided non-sterile. | Same |
| | Material | | |
| Outer Facing<br>Layer | Spunbond<br>Polypropylene | Spunbond<br>Polypropylene | Same |
| Middle Layer | Melt Blown | Melt Blown | Same |
| YANGZHOU RUNYU ARTS & CRAFTS CO., LTD. | | | |
| | Polypropylene<br>Filter | Polypropylene<br>Filter | |
| Inner Facing<br>Layer | Spunbond<br>Polypropylene | Spunbond<br>Polypropylene | Same |
| Nose Piece | Malleable aluminum<br>wire | Polyethylene | Different |
| Mask Style | Flat pleated | Flat pleated | Same |
| Design feature | Earloop, Tie Coverall,<br>3 layers | Earloop, 3 layers | Same |
| Ear loops/Ties | Ear loops: Polyester<br>Tie tapes: Spun-bond<br>Polypropylene | Ear loops: Spandex<br>and nylon | Different |
| Color | Blue | Blue | Same |
| Dimension<br>(Length ×<br>Width) | Earloop:<br>17.5 cm × 9.5 cm<br>16.5 cm × 9.0 cm<br>14.5 cm × 9.5 cm<br>Tie Coverall:<br>17.5 cm × 9.5 cm | Earloop:<br>14 cm × 9 cm | Similar |
| OTC Use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use | Single Use | Same |
| ASTM F2100<br>Level | Level 2 | Level 2 | Same |
| | Non-Clinical Performance Testing | | |
| Fluid<br>Resistance<br>Performance<br>ASTM F1862 | 32 Out of 32 pass at<br>120 mmHg<br>(Level 2 Fluid<br>Resistance) | 32 Out of 32 pass at<br>120 mmHg<br>(Level 2 Fluid<br>Resistance) | Same |
| Particulate<br>Filtration<br>Efficiency<br>ASTM<br>F2299 | Average 99.80% | ≥99% | Similar |
| Bacterial<br>Filtration<br>Efficiency | Average 99.77% | ≥99% | Similar |

#### 6.0 Summary of Comparison and Technological Characteristics

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# YANGZHOU RUNYI ARTS & CRAFTS CO., LTD.

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| YANGZHOU RUNYI ARTS & CRAFTS CO., LTD. | | | | | | | |
|----------------------------------------|--|--|--|--|--|--|--|
|----------------------------------------|--|--|--|--|--|--|--|

| ASTM<br>F2101 | | | |
|-----------------------------------------------------------|--------------------------------------|----------------------------|---------|
| Differential<br>Pressure<br>(Delta P)<br>MIL-M-<br>36954C | Average<br>$4.01 \text{ mmH2O/cm}^2$ | $< 6.0 \text{ mmH2O/cm}^2$ | Similar |
| Flammability<br>16 CFR 1610 | Class 1 | Class 1 | Same |
| Biocompatibility | | | |
| Cytotoxicity<br>ISO 10993-5 | Non-Cytotoxic | Non-Cytotoxic | Same |
| Sensitization<br>ISO 10993-<br>10 | Non- Sensitizing | Non- Sensitizing | Same |
| Irritation<br>ISO 10993- | Non-Irritating | Non-Irritating | Same |

#### Discussion:

First, the subject device shares the same intended use with the predicate device.

Secondly, the subject device enjoys similar technological characteristics with the predicate device. For example, they enjoy the same fluid resistance level, they are both for OTC use. Although there are differences in physical specifications such as the smaller mask dimensions, it's still similar. Therefore such differences will not affect the core usage of the subject device as a single use surgical mask and the usage effectiveness of the subject device has been verified by the performance tests listed in the comparison table.

Thirdly, the subject device enjoys same mask body materials, but the nose piece and earloop materials are different with the predicate device, the material safety of the subject device have been evaluated by relevant ISO 10993 standards, which further proves that the subject device will be as safe for use as the predicate device.

### 7.0 Non-Clinical Performance Testing

The following performance data demonstrated in 3 non-consecutive lots were provided demonstrate that the subject device met the specification found in the standard. The results demonstrated that the subject device meets the acceptance criteria found in the standard.

### 7.1 Conformity to Standards

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# YANGZHOU RUNYI ARTS & CRAFTS CO., LTD.

| Standards | Name |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ASTM<br>F1862/F1862M-17 | Standard Test Method for Resistance of Medical Face<br>Masks to Penetration by Synthetic Blood (Horizontal<br>Projection of Fixed Volume at a Known Velocity) |
| ASTM F2100-19 | Standard Specification for Performance of Materials Used<br>in Medical Face Masks |
| ASTM F2101-19 | Standard Test Method for Evaluating the Bacterial<br>Filtration Efficiency (BFE) of Medical Face Mask<br>Materials Using a Biological Aerosol of Staphylococcus<br>aureus |
| MIL-M-36945C | Differential Pressure (Delta-P) |
| ASTM<br>F2299/F2299M-03 | Standard Test Method for Determining the Initial<br>Efficiency of Materials Used in Medical Face Masks to<br>Penetration by Particulates Using Latex Spheres |
| 16 CFR PART<br>1610 | Standard for the flammability of clothing textiles |
| ISO 10993-5 | Biological evaluation of medical devices - Part 5: Tests for<br>in vitro cytotoxicity |
| ISO 10993-10 | Biological evaluation of medical devices - Part 10: Tests<br>for Irritation and skin sensitization |

### 7.2 Performance Testing-Bench

| Standards | Test purpose | Acceptance Criteria | Result |
|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|--------|
| Resistance to<br>penetration by<br>synthetic blood<br><b>ASTM F1862</b> | Testing the efficiency<br>of resistance to<br>penetration by<br>synthetic blood. | Level 2: 29 out of 32<br>passed in 120 mmHg<br><br>3 non-consecutive<br>lots, 32 samples<br>per lot, AQL 4% | Pass |
| Sub-micron<br>particulate filtration<br>efficiency at<br>0.1 micron<br><b>ASTM F2299</b> | Testing the efficiency<br>of the filter material in<br>capturing aerosolized<br>particles smaller than<br>one micron. | Level 2: ≥ 98%<br><br>3 non-consecutive<br>lots, 32 samples<br>per lot, AQL 4% | Pass |
| Bacterial filtration<br>efficiency<br><b>ASTM F2101-19</b> | Testing the<br>effectiveness of<br>medical face mask<br>material in preventing | Level 2: ≥ 98%<br><br>3 non-consecutive<br>lots, 32 samples | Pass |

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| | the passage of<br>aerosolized bacteria. | per lot, AQL 4% | |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|------|
| Differential<br>pressure MIL-M-<br>36954 | Measuring the<br>pressure of dropping<br>across a medical face<br>mask material. | Level 2:<br>< 6.0mmH2O/cm²<br><br>3 non-consecutive<br>lots, 32 samples<br>per lot, AQL 4% | Pass |
| Flame spread<br>16 CFR 1610 | Testing the<br>characteristics of a<br>material that pertain<br>to its relative ease of<br>ignition and relative<br>ability to sustain co<br>mbustion. | Class 1<br>Non-Flammable<br><br>3 non-consecutive<br>lots, 32 samples<br>per lot, AQL 4% | Pass |

### YANGZHOU RUNYI ARTS & CRAFTS CO., LTD.

### 7.3 Biocompatibility Testing

| Standards | Proposed Device | Result |
|-----------------------------------------|----------------------------------------------------------------------|--------|
| Cytotoxicity<br>ISO 10993-5 | Under the conditions of the study, the<br>device is non-cytotoxic. | Pass |
| Skin Sensitization Test<br>ISO 10993-10 | Under the conditions of the study, the<br>device is non-sensitizing. | Pass |
| Skin Irritation Test<br>ISO 10993-10 | Under the conditions of the study, the<br>device is non-irritating. | Pass |

### 8.0 Clinical Performance Testing

No clinical study is included in this submission.

### 9.0 Conclusion

The conclusion drawn from the non-clinical tests demonstrates that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.