Single-use Medical Face Mask

K203591 · Conod Medical Co., Limited · FXX · Jul 2, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K203591
• Device Name: Single-use Medical Face Mask
• Applicant: Conod Medical Co., Limited
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Jul 2, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The Single-use Medical Face 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

Single-use, non-sterile, flat-pleated medical face mask; three-layer construction (spun-bond polypropylene outer/inner layers; melt-blown polypropylene filter middle layer); includes malleable aluminum nose piece and either polyester ear loops or spun-bond polypropylene tie tapes. Device functions as self-inhalation filter; captures aerosolized particles/microorganisms during inhalation/exhalation. Used in clinical/general settings for infection control; reduces exposure to blood/body fluids. Healthcare providers/patients wear device to provide barrier protection. Benefits include reduced risk of cross-contamination and particulate exposure.

Clinical Evidence

Bench testing only. Performance evaluated against ASTM F2100-19 Level 2 criteria across 3 non-consecutive lots. Results: Bacterial Filtration Efficiency (BFE) average 99.77% (≥98% required); Sub-micron Particle Filtration Efficiency average 99.80% (≥98% required); Differential Pressure average 4.01 mmH2O/cm² (<6.0 required); Synthetic blood penetration resistance passed at 120 mmHg; Flammability Class 1. Biocompatibility testing (cytotoxicity, sensitization, irritation) confirmed non-cytotoxic, non-irritant, and non-sensitizing.

Technological Characteristics

Three-layer nonwoven construction: spun-bond polypropylene (outer/inner), melt-blown polypropylene (filter). Malleable aluminum nose piece. Polyester ear loops or spun-bond polypropylene tie tapes. ASTM F2100-19 Level 2 compliant. Non-sterile, single-use, disposable. Dimensions: 17.5x9.5cm, 16.5x9.0cm, 14.5x9.5cm (earloop); 17.5x9.5cm (tie).

Indications for Use

Indicated for use by patients and healthcare personnel to protect against transfer of microorganisms, body fluids, and particulate material 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

• Disposable Medical Face Masks (K202719)

Submission Summary (Full Text)

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July 2, 2021

Conod Medical Co., Limited % Olivia Meng Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technical Service Co., Ltd. 8-9th Floor, R&D Building, No.26 Qinglan Street, Panyu District Guangzhou, Guangdong 510006 China

Re: K203591

Trade/Device Name: Single-use Medical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: May 6, 2021 Received: May 12, 2021

Dear Olivia Meng:

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 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 Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K203591

Device Name Single-use Medical Face Mask

### Indications for Use (Describe)

The Single-use Medical Face 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) |
|-------------------------------------------------|
|-------------------------------------------------|

|--|--|

| | 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

In accordance with 21 CFR 807.92 the following summary of information is provided:

## 1. SUBMITTER

Conod Medical Co., Limited No.11 Hongfeng Road, Baimao Industrial Park, Guli Town, Changshu City, Jiangsu Province, China Phone: [phone] Fax: [phone]

| Primary Contact Person: | Olivia Meng |
|---------------------------|--------------------------------------------------------------|
| | Regulatory Affairs Manager |
| | Guangzhou Osmunda Medical Device Technical Service Co., Ltd. |
| | Tel: [phone] |
| | Fax: [phone] |
| Secondary Contact Person: | Ms. Carrie Wu |
| | Compliance Director |
| | Conod Medical Co., Limited |
| | Phone: [phone] |
| | Fax: [phone] |
| Date prepared | May 6th, 2021 |

2. DEVICE

| Device Name: | Single-use Medical Face Mask |
|-------------------|------------------------------|
| Common name: | Mask, Surgical |
| Model: | Earloop: ARR-DMM-175-50 |
| | ARR-DMM-165-50 |
| | ARR-DMM-145-50 |
| | Tie Coverall: ARR-DTM-175-50 |
| Regulation number | 21 CFR 878.4040 |
| Regulation Class: | II |
| Product Code: | FXX |

3. PREDICATE DEVICE
K202719, Disposable Medical Face MasksThis predicate has not been subject to a design-related recall.

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### DEVICE DESCRIPTION 4.

The Single-use Medical Face Mask is designed and manufactured by Conod Medical Co., Limited. It is non-sterile and for single use.

The Single-use Medical Face Mask has two models, Earloop and Tie Coverall. It is made of three-layer nonwovens, ear loops (for Earloop model)/ tie tapes (for Tie Coverall model) and nose piece. Inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops/ tie tapes are held in place over the users' mouth and nose by two elastic ear loops/ tie tapes welded to the mask. The ear loops are made of polyester, and the tie tapes are made of spun-bond polypropylene. The nose piece in the layers of mask is to allow the user to fit the mask around their nose, which is made of malleable aluminum wire.

It is a self-inhalation filter mask, which works by filtering the air containing harmful substances through the filter material of the mask before being inhaled or exhaled.

The product is level 2 according to ASTM F2100-19. The main parameters of the product are listed as followed:

- . Bacterial filtration efficiency (BFE) ≥ 98%
- . Sub-micron particle filtration efficiency ≥ 98%
- . Different pressure: < 6.0 mm H₂O/cm²
- י Flammability: class 1
- . Resistance to penetration by synthetic blood: 120 mmHg

### 5. INDICATIONS FOR USE

The Single-use Medical Face 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.

### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE 6. DEVICE

| Item | Proposed device | Predicate device | Comparison<br>result |
|--------------|----------------------------|---------------------------------|----------------------|
| Manufacturer | Conod Medical Co., Limited | Jiangxi Sanxin Medtec Co., Ltd. | NA |
| 510K Number | K203591 | K202719 | NA |

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K203591

| Product<br>Common<br>Name | Single-use Medical Face Mask | Disposable Medical Face Masks | NA |
|-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Intended Use | The Single-use Medical Face<br>Masks are intended to be worn to<br>protect both the patient and<br>healthcare personnel from<br>transfer of microorganisms, body<br>fluids and particulate material.<br>These face masks are intended for<br>use in infection control practices<br>to reduce the potential exposure<br>to blood and body fluids. This is a<br>single use, disposable device(s),<br>provided non-sterile. | The non-sterile disposable<br>medical 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<br>material. These face masks are<br>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, provided non-<br>sterile. | Same |
| Mask style | Flat pleated | Flat pleated | Same |
| Design feature | Earloop, Tie Coverall, 3 layers | Ear-loop, Tie-on, 3 layers | Same |
| Material of outer<br>facing layer | Spun-bond polypropylene | Polypropylene non-woven fabric | Similar |
| Material of middle<br>layer | Melt blown polypropylene filter | Melt-blown polypropylene | Same |
| Material of inner<br>facing layer | Spun-bond Polypropylene | Polypropylene non-woven fabric | Similar |
| Nose piece | Malleable aluminum wire | Galvanized iron wire coated with<br>polypropylene | Different |
| Attachment | Ear loops: Polyester<br><br>Tie tapes: Spun-bond<br>Polypropylene | Ear strap (ear-loop): Polyester<br>and spandex<br><br>Ear strap (tie-on): Polypropylene<br>non-woven fabric | Similar |
| Color | Blue | Blue | Same |
| Dimension (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><br>Tie Coverall:<br>17.5 cm × 9.5 cm | Ear-loop:<br>17.5 cm × 9.5 cm<br>16.0 cm × 9.5 cm<br>15.5 cm × 9.5 cm<br>14.5 cm × 9.5 cm<br>14.0 cm × 9.5 cm<br><br>Tie-on:<br>Same as above | Similar |
| OTC use | Yes | Yes | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Single use | Yes | Yes | Same |
| ASTM F 2100 level | Level 2 | Level 2 | Same |
| Fluid Resistance<br>Performance<br>ASTM F1862 | 32 out of 32 pass at 120<br>mmHg | Pass at 120 mmHg | Same |
| Particulate<br>Filtration<br>Efficiency ASTM<br>F2299 | Average 99.80% | 98.17% | Similar |
| Bacterial<br>Filtration<br>Efficiency ASTM<br>F2101 | Average 99.77% | 98.38% | Similar |
| Differential<br>Pressure (Delta<br>P) ASTM<br>F2100 | Average 4.01 mmH2O/cm² | 1.78 mmH2O/cm² | Similar |
| Flammability 16<br>CFR 1610 | Class 1<br>Non-Flammable | Class 1<br>Non-Flammable | Same |
| Biocompatibility | | | |
| Cytotoxicity | Under the conditions of the<br>study, not cytotoxic | Under the conditions of the<br>study, not cytotoxic | Same |
| Irritation | Under the conditions of the<br>study, not an irritant | Under the conditions of the<br>study, not an irritant | Same |
| Sensitization | Under conditions of the study,<br>not a sensitizer | Under conditions of the study,<br>not a sensitizer | Same |

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The proposed Single-use Medical Face Mask and the predicate device are identical in the intended use, mask style, design feature, material, ASTM F2100 level and biocompatibility, and similar only in dimension and some components material.

### 7. PERFORMANCE DATA

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.

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| | Test item | Test purpose | Acceptance criteria | Results |
|------------------|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|---------|
| Performance test | Flammability | Testing the characteristics of<br>a material that pertain to its<br>relative ease of ignition and<br>relative ability to sustain combustion. | Class 1<br>ASTM F2100<br>3 non-consecutive<br>lots, 32 samples<br>per lot | Pass |
| | Bacterial Filtration<br>Efficiency | Testing the effectiveness of<br>medical face mask material<br>in preventing the passage of<br>aerosolized bacteria. | Level 2: ≥ 98%<br>ASTM F2100<br>3 non-consecutive<br>lots, 32 samples<br>per lot | Pass |
| | Different Pressure,<br>mm H2O/cm² | Measuring the pressure of<br>dropping across a medical<br>face mask material. | Level 2: < 6.0<br>ASTM F2100<br>3 non-consecutive<br>lots, 32 samples<br>per lot | Pass |
| | Sub-Micron<br>Particle Filtration<br>Efficiency | Testing the efficiency of the<br>filter material in capturing<br>aerosolized particles smaller<br>than one micron. | Level 2: ≥ 98%<br>ASTM F2100<br>3 non-consecutive<br>lots, 32 samples<br>per lot | Pass |
| | Resistance to<br>Penetration by<br>synthetic blood | Testing the efficiency of<br>resistance to penetration by<br>synthetic blood. | Level 2: pass at<br>120 mmHg<br>ASTM F2100<br>3 non-consecutive<br>lots, 32 samples<br>per lot | Pass |
| Biocompatibility | Cytotoxicity | Determining the cytotoxicity<br>of proposed device. | Pass | Pass |
| | Sensitization | Determining whether the<br>proposed device has<br>sensitization potential. | Pass | Pass |
| | Skin Irritation | Determining whether the<br>proposed device has<br>irritation potential. | Pass | Pass |

## 8. CONCLUSION

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