(23 days)
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.
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.
The provided document is a 510(k) summary for the Avianz® Surgical Face Mask. It details the device's characteristics, intended use, and conformance to performance standards.
Here's the breakdown of the acceptance criteria and study information:
1. Acceptance Criteria and Reported Device Performance
| Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Fluid Resistance Performance (ASTM F1862) | 29 Out of 32 pass at 120 mmHg | 30 Out of 32 pass at 120 mmHg |
| Particulate Filtration Efficiency (ASTM F2299) | ≥ 98% | 99.9% |
| Bacterial Filtration Efficiency (ASTM F2101) | ≥ 98% | > 99.9% |
| Differential Pressure (Delta P) MIL-M-36954C | < 5.0 mmH2O/cm² | 3.0 mmH2O/cm² |
| Flammability (16 CFR 1610) | Class 1 | Class 1 |
| Biocompatibility Results | Non-Cytotoxic, Non-Sensitizing, Non-Irritating | Non-Cytotoxic, Non-Sensitizing, Non-Irritating |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for all tests. For the Fluid Resistance Performance, the test involved 32 samples (30 out of 32 passed). The document does not specify the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided. The studies are laboratory performance tests against established standards, not human-read clinical studies.
4. Adjudication Method for the Test Set
Not applicable. The tests are based on objective laboratory measurements against defined standards, not subjective assessments requiring expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The device is a surgical face mask, and its performance is evaluated through laboratory tests rather than through human reader interpretation of data.
6. Standalone Performance Study (Algorithm Only)
Not applicable, as this is a physical medical device (surgical face mask), not an algorithm or AI-powered device. The "performance" refers to the physical properties of the mask.
7. Type of Ground Truth Used
The ground truth for the device's performance is established by validated laboratory test standards. These standards (e.g., ASTM F1862, ASTM F2299, ASTM F2101, MIL-M-36954C, 16 CFR 1610) define the methodologies and criteria for evaluating the physical and biological barrier properties of surgical masks.
8. Sample Size for the Training Set
Not applicable. There is no training set mentioned in the context of this device, as it is not an AI/ML-driven device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
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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
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
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Indications for Use
510(k) Number (if known)
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510K SUMMARY
Date of Summary Prepared: April 20, 2020
510K Number: K200847
- 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 : mexpoglove@aol.com
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.
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7. Summary of Comparison and Technological Characteristics
Table 1 - General Comparison
| Device | Proposed Device | Predicate Device | Result |
|---|---|---|---|
| Manufacturer | MEXPO INTERNATIONALINC. | Thai Hospital Products Co. Ltd. | - |
| 510K Number | K200847 | K911334 | - |
| Product CommonName | 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, thesurgical face masks areintended to protect bothpatient and healthcareworkers from transfer ofmicroorganisms, body fluidsand airborne particles. Thisdevice is non-sterile and forsingle use only. | When properly worn, thesurgical face masks areintended to protect both patientand healthcare workers fromtransfer of microorganisms,body fluids and airborneparticles. This device is non-sterile and for single use only. | Same |
| Model | 3 Ply, Ear Loops, Flat-PleatedStyle | 3 Ply, Ear Loops or Tie-On | Similar |
| Materials | |||
|---|---|---|---|
| Outer FacingLayer | Spunbond Polypropylene | Spunbond Polypropylene | Same |
| Middle Layer | Melt Blown PolypropyleneFilter | Melt Blown Polypropylene Filter | Same |
| Inner Facing Layer | Spunbond Polypropylene | Spunbond Polypropylene | Same |
| Nose Piece | Single Galvanize Wire, CoatedBy PE | Single Galvanize Wire, Coated ByPE | Same |
| Ear Loops | not made with natural rubber latex | not made with natural rubber latex | Same |
| Color | White | Blue, Pink, Yellow, Green,Orange, Purple, White & MultiColor | Similar |
| Dimension (Width) | $9.0cm \pm 0.5cm$ | $9.0cm \pm 0.5cm$ | Same |
| Dimension(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 |
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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 |
|---|---|---|---|
| FluidResistancePerformanceASTM F1862 | 30 Out of 32 pass at 120mmHg | 29 Out of 32 pass at 120mmHg | Pass |
| ParticulateFiltrationEfficiencyASTM F2299 | 99.9% | ≥ 98% | Pass |
| BacterialFiltrationEfficiencyASTM F2101 | > 99.9% | ≥ 98% | Pass |
| DifferentialPressure(Delta P) MIL-M-36954C | 3.0 mmH20/cm² | < 5.0 mmH20/cm² | Pass |
| Flammability16 CFR 1610 | Class 1 | Class 1 | Pass |
Table 3 - Biocompatibility Testing
| Item | Proposed Device | Acceptance Criteria | Result |
|---|---|---|---|
| Results | Non-Cytotoxic, Non-Sensitizing, Non-Irritating | Non-Cytotoxic, Non-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.
§ 878.4040 Surgical apparel.
(a)
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.(b)
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.