TAIJI Professional Series Level 3 Surgical Face Mask

K211861 · Taiji Medical Supplies, Inc. · FXX · Jul 28, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K211861
• Device Name: TAIJI Professional Series Level 3 Surgical Face Mask
• Applicant: Taiji Medical Supplies, Inc.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Jul 28, 2021
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4040
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The TAIJI Professional Series Level 3 Surgical 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 intended for use in infection control practices to reduce the potential exposure to blood and body fluid. This is a single use, disposable device, provided non-sterile.

Device Story

Flat-pleated surgical face mask; three-layer construction (spunbond polypropylene outer/inner layers, meltblown polypropylene filter layer); secures via elastic ear loops; includes malleable nosepiece. Used in healthcare/surgical settings to protect patients and personnel from microorganisms, body fluids, and particulates. Single-use, disposable, non-sterile. Provides barrier protection against blood/body fluids; tested to ASTM F2100 Level 3 standards.

Clinical Evidence

Bench testing only. Performance verified against ASTM F2100-19, ASTM F1862 (synthetic blood penetration at 160 mmHg), ASTM F2101-19 (BFE ≥98%), and EN 14683:2019 (differential pressure <6.0 mm H2O/cm²). Safety testing included flammability (21 CFR 1610, Class 1) and biocompatibility (ISO 10993-5, -10, -11).

Technological Characteristics

Three-layer nonwoven polypropylene (spunbond outer/inner, meltblown filter). Malleable nosepiece (polyethylene/aluminum wire). Elastic ear loops (polyester/spandex). Dimensions: 17.5cm x 9.5cm. ASTM F2100 Level 3 performance. Non-sterile, single-use.

Indications for Use

Indicated for use by healthcare personnel and patients to reduce the transfer of microorganisms, body fluids, and particulate material, and to reduce potential exposure to blood and body fluids during 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

• Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask (K202595)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains 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. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 28,2021

Taiji Medical Supplies, Inc. % Abdel Halim President, Global and Regulatory Affairs Global Quality and Regulatory Services 10 Scenic Way Monroe, New Jersey 08831

Re: K211861

Trade/Device Name: TAIJI Professional Series Level 3 Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: July 21, 2021 Received: July 23, 2021

Dear Abdel Halim:

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

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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,

For 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 Ouality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K211861

Device Name

TAIJI Professional Series Level 3 Surgical Face Mask

Indications for Use (Describe)

The TAIJI Professional Series Level 3 Surgical 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 intended for use in infection control practices to reduce the potential exposure to blood and body fluid. This is a single use, disposable device, provided non-sterile.

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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Image /page/3/Picture/0 description: The image shows the logo for TAJI Medical Supplies. The logo consists of the letters "TMS" in blue, with the words "TAJI Medical Supplies" in a smaller font below. To the right of the letters is a red graphic that looks like two curved lines. The logo is simple and professional, and the colors are eye-catching.

# 510(k) Summary

This 510(k) Summary is being submitted in accordance with the requirements of Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submissions, Issued March 5, 2004 (corrected July 14, 2004).

## 1. Device and Company Details:

510(k) Number: K211861

| Submitter / Owner<br>Taiji Medical Supplies, Inc.<br>3211 Progress Drive<br>Lincolnton, NC 28092<br>T: [phone]<br>E: [e-mail] | Contact Person<br>Ms. Katherine L. Giannamore, Esq.<br>Shehadeh Giannamore, PLLC<br>396 Alhambra Circle, Suite 100A<br>Coral Gables, FL 33134<br>T: [phone]<br>E: [e-mail] |
|------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Preparation of this Summary: | June 10, 2021 |
| Device Trade or Proprietary Name: | TAIJI Professional Series Level 3 Surgical<br>Face Mask |
| Device Common/Usual Name: | Surgical Mask |
| Regulation Name/Device Class/<br>Product Code: | Surgical Apparel/Class II/FXX |
| Predicate Device Name/K Number: | Premier Guard USA 3 Layer Ear Loop<br>ASTM Level 3 Surgical Face Mask/K202595 |

2. Device Description: The TAIJI Professional Series Level 3 Surgical Face Mask is in accordance with the FDA Guidance Document, Surgical Masks - Premarket Notification [510K)] Submissions issued on March 5, 2004. TAIJI Professional Series Level 3 Surgical Face mask is a flat-pleated style mask with elastic ear loops to secure it over the users' mouth and face. The mask consists of three-layers. The inner facing layer is white and is manufactured from spunbond polypropylene (three layers of nonwoven polypropylene). The inner filter material is made of meltblown fiber. The outer facing layer is blue and is manufactured from spunbond polypropylene (three layers of nonwoven polypropylene).

The mask is a single use, disposable device, provided nonsterile.

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Image /page/4/Picture/0 description: The image contains the logo for TAJI Medical Supplies. The logo consists of the letters "TMS" in blue, with the words "TAJI Medical Supplies" in a smaller font below. To the right of the letters are two red curved lines that resemble a stylized heartbeat or wave pattern. The logo is simple and modern, with a clear emphasis on the company's name and medical focus.

Intended Use: The TAIJI Professional Series Level 3 Surgical Face Mask is a non- sterile, single-use, disposable mask, intended to be worn in healthcare and surgical procedures.

## 3. Technological Characteristics Comparison:

The following is a summary of the technological characteristics of the TAIJI Professional Series Level 3 Surgical Face Mask as compared to the predicate device.

| Items | Subject Device<br>TAIJI<br>Professional<br>Series Level 3<br>Surgical Face<br>Mask | Predicate Device<br>K202595 | Comparison | | |
|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|
| Manufacturer | TAIJI Medical<br>Supplies, Inc. | Premier Guard<br>USA, LLC | N/A | | |
| 510(k) Number | K211861 | K202595 | N/A | | |
| FDA Product Code | FXX | FXX | Same | | |
| Indications for Use | The TAIJI<br>Professional<br>Series Level 3<br>Surgical Face<br>Masks are<br>intended to be<br>worn to protect<br>both the patient<br>and healthcare<br>personnel from<br>transfer of<br>microorganisms,<br>body fluids and<br>particulate<br>material. These<br>face masks are<br>intended for use<br>in infection<br>control practices<br>to reduce the<br>potential<br>exposure to<br>blood and body<br>fluid. This is a<br>single use,<br>disposable<br>device, provided<br>non-sterile | The Premier<br>Guard USA 3<br>Layer Ear Loop<br>ASTM Level 3<br>Surgical Face<br>Masks are<br>intended to be<br>worn to protect<br>both the patient<br>and healthcare<br>personnel from<br>transfer of<br>microorganisms,<br>body fluids and<br>particulate<br>material. These<br>face masks are<br>intended for use in<br>infection control<br>practices to<br>reduce the<br>potential exposure<br>to blood and body<br>fluid. This is a<br>single use,<br>disposable device,<br>provided non-<br>sterile | Same | | |
| | Inner and Outer<br>Layers | Spun-bond<br>polypropylene | Spun-bond<br>polypropylene | | |
| Materials | Middle Layer | Melt blown<br>polypropylene<br>filter | Melt blown<br>polypropylene<br>filter | Same | |
| | Ear Loops | Polyester with<br>Spandex inner-<br>core | Nylon and<br>Spandex | Similar | |
| | Nose Piece | Malleable<br>polyethylene<br>with aluminum<br>wire | Polyethylene<br>laminated soft<br>annealed carbon<br>steel wire | Similar | |
| | Dimensions | | 17.5cm length x<br>9.5cm height | 17.5cm length x<br>9.5cm height | Same |
| Mask Style | | Flat Pleated | Flat Pleated | Same | |
| Design Features | | Malleable<br>nosepiece, flat-<br>pleated elastic<br>ear loops | Malleable<br>nosepiece, flat-<br>pleated elastic ear<br>loops | Same | |
| Sterility | | Non-sterile | Non-sterile | Same | |
| Use | | Single Use,<br>Disposable | Single Use,<br>Disposable | Same | |
| Color | | Blue and White | Blue and White | Same | |
| ASTM F2100 Level | | Level 3 | Level 3 | Same | |
| Biocompatibility | | | | | |
| Cytotoxicity | | Under<br>conditions of the<br>study,<br>the<br>device<br>considered is<br>cytotoxic (neat<br>and 1:2 extracts<br>were scored 3) | Under conditions<br>of the study, the<br>device is Non-<br>cytotoxic | Fail -<br>Acute Systemic<br>Study was<br>recommended<br>by 3PR and<br>agreed upon by<br>FDA | |
| | | Systemic Study / Systemic<br>Injection Test / ISO GLP ISO<br>10993-11:<br>evaluation of medical devices<br>- Part 11: Tests for systemic<br>toxicity | Under<br>conditions of the<br>study,<br>the<br>device is non-<br>cytotoxic | N/A | Pass<br>No systemic<br>toxicity: device<br>is not toxic |
| | | Irritation | | Under<br>conditions of the<br>study,<br>the<br>device is Non-<br>irritating | Under conditions<br>of the study, the<br>device is Non-<br>irritating |
| Sensitization | Under<br>conditions of the<br>study, the<br>device is Non-<br>sensitizing | Under conditions of<br>the study, the<br>device is Non-<br>sensitizing | Same | | |
| Fluid Resistance Performance<br>(mmHg) | Pass at 160<br>mmHg | Pass at 160<br>mmHg | Same | | |
| Particulate Filtration Efficiency<br>Performance (%) | Pass at ≥98% | Pass at ≥98% | Same | | |
| Bacterial Filtration Efficiency<br>Performance (%) | Pass at ≥98% | Pass at ≥98% | Same | | |
| Differential Pressure (Delta-<br>P) (mm H O/cm ) | Pass at ≤6.0 | Pass at <6.0 | Same | | |
| Flammability class<br>Class 1 | Pass Class 1 | Pass Class 1 | Same | | |

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Image /page/5/Picture/0 description: The image shows the logo for TMS, which likely stands for TAUi Medical Supplies. The letters 'TMS' are in bold, blue font, with 'TAUi Medical Supplies' written in a smaller font underneath. To the right of the letters is a red graphic that resembles two curved lines, possibly representing a medical symbol or a stylized design element.

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Image /page/6/Picture/0 description: The image shows the logo for TAJI Medical Supplies. The logo has the letters "TMS" in blue, with the words "TAJI Medical Supplies" in a smaller font below the letters. To the right of the letters is a red graphic that looks like two curved lines, possibly representing a medical symbol. The logo is simple and professional, and the colors are eye-catching.

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Image /page/7/Picture/0 description: The image contains the logo for TMS, which stands for TAUI Medical Supplies. The letters "TMS" are in a bold, sans-serif font and are colored blue. Below the letters, the words "TAUI Medical Supplies" are written in a smaller, lighter font. To the right of the letters, there are two curved, red shapes that resemble waves or swooshes.

# 4. Summary of Non-Clinical Testing

Per FDA document Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submissions, the below testing has been completed on the subject device:

| Standard/Test Methodology | Purpose | Acceptance<br>Criteria | Results |
|----------------------------------------------------------------------------------------------------------------------------------------|------------------|------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| ASTM F1862: Standard Test<br>Method for Resistance of<br>Medical Face Masks to<br>Penetration by Synthetic<br>Blood | Barrier Testing | At least 29<br>out of 32 specimens<br>show passing<br>results at 160<br>mmHg | Samples met<br>the<br>predetermine<br>d acceptance<br>criteria |
| ASTM F2101-19: Standard<br>Specification for<br>Performance of Materials<br>Used in Medical Face<br>Masks | Barrier Testing | ≥98% | Samples met<br>the<br>predetermine<br>d acceptance<br>criteria<br>96 Samples,<br>3 non-<br>consecutive<br>lots of 32<br>each |
| EN 14683:2019 Annex C<br>and ASTM F2100-19:<br>Standard Specification for<br>Performance of Materials<br>Used in Medical Face<br>Masks | Physical Testing | <6.0 mm<br>H2O/cm² | Samples met<br>the<br>predetermine<br>d acceptance<br>criteria<br>96 Samples,<br>3 non-<br>consecutive<br>lots of 32<br>each |
| ASTM F2100-19: Standard<br>Specification for<br>Performance of Materials<br>Used in Medical Face<br>Masks | Barrier Testing | ≥98% | Samples met<br>the<br>predetermine<br>d acceptance<br>criteria<br>96 Samples,<br>3 non-<br>consecutive |
| | | | lots of 32<br>each |
| 21 CFR 1610 | Safety Testing | Class 1, Does not<br>ignite | Samples<br>met the<br>predetermin<br>ed<br>acceptance<br>criteria<br>96 Samples,<br>3 non-<br>consecutive<br>lots of 32<br>each |
| ISO 10993-5: Biological<br>evaluationofmedical<br>devices - Part 5: Tests<br>for in vitro cytotoxicity | Safety Testing | Non-cytotoxic | Fail |
| ISO 10993-11: Biological<br>evaluation of medical<br>devices - Part 11: Tests for<br>systemic toxicity | Safety Testing | Under conditions of<br>the study, the device<br>is non- cytotoxic | Pass<br>No systemic<br>toxicity: device<br>is not toxic |
| ISO 10993-10: Biological<br>evaluation of medical<br>devices - Part 10: Tests<br>for irritation and skin<br>sensitization | Safety Testing | Non-irritating | Pass |
| ISO 10993-10: Biological<br>evaluationofmedical<br>devices - Part 10: Tests<br>for irritation and<br>skin sensitization | Safety Testing | Non- sensitizing | Pass |

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Image /page/8/Picture/0 description: The image shows the logo for TAUI Medical Supplies. The logo consists of the letters "TMS" in blue, with the words "TAUI Medical Supplies" in a smaller font below. To the right of the letters is a red graphic that resembles two curved lines. The logo is simple and professional, and the colors are eye-catching.

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Image /page/9/Picture/0 description: The image shows the logo for TMS, which likely stands for TAUI Medical Supplies. The letters "TMS" are in bold, blue font, with the words "TAUI Medical Supplies" in a smaller font underneath. To the right of the letters is a red graphic that looks like two curved lines, possibly representing a flag or a medical symbol. The logo is simple and professional, suggesting a reliable and trustworthy company.

# 5. Conclusion:

The conclusions drawn from the nonclinical tests demonstrate that the subject device K211861 TAIJI Medical Professional Series Level 3 Surgical Face Mask is as safe, as effective and performs as well or better than the legally marketed predicate device, K202595 Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask.