Surgical Face Mask

K200847 · Mexpo International, Inc. · FXX · Apr 23, 2020 · General, Plastic Surgery

Device Facts

• Record ID: K200847
• Device Name: Surgical Face Mask
• Applicant: Mexpo International, Inc.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Apr 23, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

When properly worn, the surgical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and airborne particles. This device is non-sterile and for single use only.

Device Story

Avianz® Surgical Face Mask is a non-sterile, single-use, 3-layer flat-pleated mask with ear loops and a nose piece. Constructed with spunbond polypropylene outer/inner layers and a melt-blown polypropylene filter middle layer. Designed to be worn over the nose and mouth to provide a physical barrier against microorganisms, body fluids, and airborne particles. Used in clinical or general settings; operated by healthcare personnel or patients. Provides protection through mechanical filtration and fluid resistance; helps reduce cross-contamination risk between patients and healthcare workers.

Clinical Evidence

No clinical data. Bench testing only. Performance testing included fluid resistance (ASTM F1862), particulate filtration efficiency (ASTM F2299), bacterial filtration efficiency (ASTM F2101), differential pressure (MIL-M-36954C), and flammability (16 CFR 1610). Biocompatibility testing confirmed the device is non-cytotoxic, non-sensitizing, and non-irritating.

Technological Characteristics

3-layer flat-pleated design. Materials: Spunbond polypropylene (outer/inner), melt-blown polypropylene (filter), galvanized wire coated with PE (nose piece). Dimensions: 17.5cm x 9.0cm. ASTM F2100 Level 2 compliant. Non-sterile, single-use. No natural rubber latex.

Indications for Use

Indicated for use by patients and healthcare workers to protect against the transfer of microorganisms, body fluids, and airborne particles.

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

• Mask, Surgical Apparel (K911334)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 23, 2020

Mexpo International Inc. Tim Thai President 2828 Faber Street Union City, California 94587

Re: K200847

Trade/Device Name: Avianz® Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 2, 2020 Received: April 6, 2020

Dear Mr. Thai:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

{1}------------------------------------------------

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 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,

CAPT Elizabeth Claverie, MS 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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known)

K200847

Device Name

Avianz® Surgical Face Mask

Indications for Use (Describe)

When properly worn, the surgical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and airborne particles. This device is non sterile and for single use only.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><input type="checkbox"/>Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><input checked="checked" type="checkbox"/>Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

#### 510K SUMMARY

### Date of Summary Prepared: April 20, 2020

#### 510K Number: K200847

1. Applicant : MEXPO INTERNATIONAL INC. Address : 2828 Faber Street, Union City, CA 94587, U.S.A. Tel : 510 — 489 6800 : 510 - 489 3111 Fax E-mail : [e-mail]

Official Correspondence: Tim Thai (President)

### 2. Device Name: Avianz® Surgical Face Mask

#### 3. Regulatory Information

| Classification Name | : Surgical Face Mask, Apparel |
|---------------------|-------------------------------|
| Classification | : Class II |
| Product Code | : FXX |
| Regulation Number | : 21 CFR 878.4040 |

#### 4. Predicate Device

| 510K Number | : K911334 - Thai Hospital Products Co. Ltd |
|-------------|--------------------------------------------|
| Device Name | : Mask, Surgical Apparel |

#### 5. Intended Use

When properly worn, the surgical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and airborne particles. This device is non-sterile and for single use only.

#### 6. Device Description

The surgical face masks are non-sterile, single use, 3 layers, flat-pleated style with ear loops and nose piece. The outer layer and inner facing layer of face mask consist of Spunbond Polypropylene, and the middle layer consists of Melt Blown Polypropylene Filter. Each mask contains ear loops to secure the mask over the user's face and mouth with nose piece to firmly fit over the nose. This device is not made from any natural rubber latex.

{4}------------------------------------------------

# 7. Summary of Comparison and Technological Characteristics

### Table 1 - General Comparison

| Device | Proposed Device | Predicate Device | Result |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Manufacturer | MEXPO INTERNATIONAL<br>INC. | Thai Hospital Products Co. Ltd. | - |
| 510K Number | K200847 | K911334 | - |
| Product Common<br>Name | SURGICAL FACE MASK | SURGICAL FACE MASK | Same |
| Product Code | FXX | FXX | Same |
| Classification | Class II (21 CFR 878.4040) | Class II (21 CFR 878.4040) | Same |
| Intended Use | When properly worn, the<br>surgical face masks are<br>intended to protect both<br>patient and healthcare<br>workers from transfer of<br>microorganisms, body fluids<br>and airborne particles. This<br>device is non-sterile and for<br>single use only. | When properly worn, the<br>surgical face masks are<br>intended to protect both patient<br>and healthcare workers from<br>transfer of microorganisms,<br>body fluids and airborne<br>particles. This device is non-<br>sterile and for single use only. | Same |
| Model | 3 Ply, Ear Loops, Flat-Pleated<br>Style | 3 Ply, Ear Loops or Tie-On | Similar |

| Materials | | | |
|-----------------------|----------------------------------------|----------------------------------------------------------------------|---------|
| Outer Facing<br>Layer | Spunbond Polypropylene | Spunbond Polypropylene | Same |
| Middle Layer | Melt Blown Polypropylene<br>Filter | Melt Blown Polypropylene Filter | Same |
| Inner Facing Layer | Spunbond Polypropylene | Spunbond Polypropylene | Same |
| Nose Piece | Single Galvanize Wire, Coated<br>By PE | Single Galvanize Wire, Coated By<br>PE | Same |
| Ear Loops | not made with natural rubber latex | not made with natural rubber latex | Same |
| Color | White | Blue, Pink, Yellow, Green,<br>Orange, Purple, White & Multi<br>Color | Similar |
| Dimension (Width) | $9.0cm \pm 0.5cm$ | $9.0cm \pm 0.5cm$ | Same |
| Dimension<br>(Length) | $17.5cm \pm 0.5cm$ | $17.5cm \pm 0.5cm$ | Same |
| OTC Use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use | Single Use | Same |
| ASTM F2100 Level | Level 2 | Level 2 | Same |

{5}------------------------------------------------

### 8. Non-clinical Tests Performed on the Proposed Device

The proposed device was tested and conformed to 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.

#### Table 2 - Performance Testing

| Item | Proposed Device | Acceptance Criteria | Result |
|--------------------------------------------------------|----------------------------------|----------------------------------|--------|
| Fluid<br>Resistance<br>Performance<br>ASTM F1862 | 30 Out of 32 pass at 120<br>mmHg | 29 Out of 32 pass at 120<br>mmHg | Pass |
| Particulate<br>Filtration<br>Efficiency<br>ASTM F2299 | 99.9% | ≥ 98% | Pass |
| Bacterial<br>Filtration<br>Efficiency<br>ASTM F2101 | > 99.9% | ≥ 98% | Pass |
| Differential<br>Pressure<br>(Delta P) MIL-<br>M-36954C | 3.0 mmH20/cm² | < 5.0 mmH20/cm² | Pass |
| Flammability<br>16 CFR 1610 | Class 1 | Class 1 | Pass |

#### Table 3 - Biocompatibility Testing

| Item | Proposed Device | Acceptance Criteria | Result |
|---------|----------------------------------------------------|----------------------------------------------------|--------|
| Results | Non-Cytotoxic, Non-<br>Sensitizing, Non-Irritating | Non-Cytotoxic, Non-<br>Sensitizing, Non-Irritating | Pass |

#### 9. Conclusion

There is no clinical study included in this submission. 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.