Surgical Face Mask

K212863 · Taiwan Comfort Champ Manufacturing Co., Ltd. · FXX · Feb 19, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K212863
• Device Name: Surgical Face Mask
• Applicant: Taiwan Comfort Champ Manufacturing Co., Ltd.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Feb 19, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The Surgical Face Mask is 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 potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.

Device Story

Surgical face mask; 4-ply flat pleated design; ear-loop attachment; integrated nose band. Construction: 4 layers of polypropylene non-woven fabric; melt-blown polypropylene filter layer; nylon ear loops; polyethylene-coated steel wire nose band. Used in clinical settings for infection control; worn by healthcare personnel and patients. Provides physical barrier against droplets, sprays, and particulates. Single-use; disposable; non-sterile. User manually adjusts nose band for facial fit; secures via ear loops. Benefits: reduces cross-contamination risk; protects against fluid/particulate exposure.

Clinical Evidence

Bench testing only. No clinical data. Performance testing conducted on 3 nonconsecutive lots (96 samples total) per ASTM F2100-20: Differential pressure < 5 mmH2O/cm²; synthetic blood penetration resistance (no penetration at 160 mmHg); particulate filtration efficiency (PFE) ≥ 99.8% at 0.1 micron; bacterial filtration efficiency (BFE) ≥ 99.8%; flammability Class 1. Biocompatibility testing performed per ISO 10993-1, ISO 10993-5, and ISO 10993-10 for cytotoxicity, sensitization, and irritation.

Technological Characteristics

4-ply non-woven polypropylene construction; melt-blown filtration layer; nylon ear loops; PE-coated steel wire nose band. Dimensions: 175mm x 95mm. Non-sterile; single-use. Complies with ASTM F2100-20, ASTM F1862, ASTM F2299, ASTM F2101, and 16 CFR Part 1610.

Indications for Use

Indicated for use by healthcare personnel and patients to reduce exposure to blood, body fluids, microorganisms, and particulate material 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

• Motex Anti-Fog Surgical Face Mask, type: Tie-on, Ear-loop (K201549)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

February 19, 2022

Taiwan Comfort Champ Manufacturing Co., Ltd. % Jen Ke-Min Contact Person Chinese-European Industrial Research Society No. 58. Fu-Chiun St Hsin-Chu City, Taiwan 30067 Taiwan

Re: K212863

Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 8, 2022 Received: February 14, 2022

### Dear Jen Ke-Min:

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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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K212863

Device Name Surgical Face Mask

Indications for Use (Describe)

The Surgical Face Mask is 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 potential exposure to blood and body fluids. The face mask is 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 Taiwan Champ. The logo consists of a purple circle with a horizontal line through the middle and a green leaf shape at the bottom. To the right of the circle are the words "Taiwan Champ" in gray text, with the word "Taiwan" above the word "Champ".

### Taiwan Comfort Champ Manufacturing Co., Ltd. No.55, Aly. 51, Ln. 50, Daren Rd., Taoyuan Dist., Taoyuan City, TAIWAN Tel: [phone], Fax: [phone] Website: https://taiwan-champ.com/

## 510(k) Summary (Per 21 CFR 807.92)

510(k) number: _K212863

#### ● Submitter's information

| Name | Taiwan Comfort Champ Manufacturing Co., Ltd. |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address | No.55, Aly. 51, Ln. 50, Daren Rd., Taoyuan Dist., Taoyuan<br>City, TAIWAN |
| Telephone | Tel:[phone] |
| Fax | Fax: [phone] |
| Contact Person | Dr. Jen, Ke-Min<br>No. 58, Fu Chiun Street, Hsin Chu City, 30067, Taiwan<br>TEL: [phone] FAX: [phone]<br>Email: [e-mail] |
| Date the Summary was prepared | February 11, 2022 |

#### ● Name of the Subject Device

| Trade or Proprietary name | Surgical Face Mask |
|---------------------------|------------------------------------|
| Common or Usual name | Surgical Mask |
| Classification name | Surgical Apparel (21 CFR 878.4040) |

#### ● Predicate Device

| Owner | Modern Healthcare Corp. |
|---------------|-----------------------------------------------------------|
| Product name | Motex Anti-Fog Surgical Face Mask, type: Tie-on, Ear-loop |
| 510(k) number | K201549 |

#### ● Device descriptions

### ● General description

The Surgical Face Mask is 4 ply Flat Pleated type mask, utilizing ear loops for wearing, and it has nose band design for fitting the face mask around the nose.

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Image /page/4/Picture/0 description: The image contains a logo for Taiwan Champ. The logo consists of a circular emblem with a stylized leaf inside, and the text "台灣康匠 TAIWAN CHAMP" to the right. The emblem is purple, while the leaf is green and the text is gray.

### Taiwan Comfort Champ Manufacturing Co., Ltd. No.55, Aly. 51, Ln. 50, Daren Rd., Taoyuan Dist., Taoyuan City, TAIWAN Tel: [phone], Fax: [phone] Website: https://taiwan-champ.com/

The Surgical Face Mask is manufactured with four layers. The first and second layers are made of polypropylene (PP) non-woven fabric with green coloration. The third layer has filtration function and is made of polypropylene (PP) melt-blown non-woven fabric. The fourth layer (inner layer) contacting with face is made of polypropylene (PP) non-woven fabric without color. The functions of the four layers are as follows,

1st Layer: Water-repelling, non-woven fabric. Prevents droplet and spray penetration.

2nd Layer: Water-repelling, non-woven fabric. Prevents droplet and spray penetration.

3rd Layer: Electrostatic-induced melt-blown polypropylene, blocks dust and microbes.

- 4th Layer: PP non-woven fabric, provides soft feel and reinforces spray and droplet protection.
The Surgical Face Mask is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Nylon.

The nose band, made of steel wire coated with Polyethylene resin, contained in the subject device is in the layers of face mask to allow the user to fit the face mask around their nose.

The Surgical Face Masks are sold non-sterile and are intended to be singleuse. The size of the face mask is 175 mm * 95 mm.

#### ● Device components and materials

| NO. | Device<br>Components | Materials | Specification Material |
|-----|------------------------------|------------------------|------------------------------------|
| 1. | Face masks<br>(First layer) | Polypropylene nonwoven | 40g/m², Green non-<br>woven fabric |
| 2. | Face masks<br>(Second layer) | Polypropylene nonwoven | 30g/m² Green non-<br>woven fabric |

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Image /page/5/Picture/0 description: The image contains a logo with a stylized letter "C" on the left and text on the right. The "C" is formed by two curved lines in purple, with a horizontal line across the middle and a green leaf shape inside. To the right of the logo, there are Chinese characters in gray, followed by the English text "TAIWAN CHAM" in a smaller font size, also in gray. The logo appears to represent a Taiwanese chamber of commerce or a similar organization.

No.55, Aly. 51, Ln. 50, Daren Rd., Taoyuan Dist., Taoyuan City, TAIWAN Tel: [phone], Fax: [phone]

| Website: https://taiwan-champ.com/ | | | |
|------------------------------------|--|--|--|
| | | | |

| 3. | Face masks<br>(Third layer) | Polypropylene melt-blown<br>non-woven fabric | 20g/m² melt-blown non-<br>woven fabric |
|----|------------------------------|----------------------------------------------|----------------------------------------|
| 4. | Face masks<br>(Fourth layer) | Polypropylene nonwoven | 20g/m² white non-<br>woven fabric |
| 5. | Elastic ear loops | Nylon | white round elastic string |
| 6. | Nose band | PE | white |

### . Indications for Use

The Surgical Face Mask is 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 potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile.

| Description | Subject Device | Predicate Device | Comparison |
|----------------------|--------------------------------------------------------------------|----------------------------------------------------------------------------|------------|
| Manufacturer | Taiwan Comfort Champ<br>Manufacturing Co., Ltd. | Modern Healthcare Corp. | -- |
| Product trade name | Taiwan Comfort Champ Surgical<br>Face Mask | Motex Anti-Fog Surgical Face<br>Mask, type: Tie-on, Ear-loop | -- |
| 510(k) number | K212863 | K201549 | -- |
| Classification name | Apparel, Surgical | Apparel, Surgical | Same |
| Product Code | FXX | FXX | Same |
| Device Class | 2 | 2 | Same |
| Regulation number | 878.4040 | 878.4040 | Same |
| Material composition | Inner (Fourth) layer:<br>Polypropylene non-woven fabric | Inner layer: Bicomponent<br>thermal-bonded nonwoven<br>(PP/PE) | Different |
| | Third (filter) layer: Polypropylene<br>melt-blown non-woven fabric | Filter layer: Polypropylene<br>Melt-blown | |
| | Second layer: Polypropylene<br>non-woven fabric | Outer layer: Polypropylene<br>Spunbond (blue, green, white,<br>pink color) | |
| | First layer: Polypropylene<br>non-woven fabric (green color) | Anti-Fog film: EP coated<br>Polyethylene | |
| | Nose band: Polyethylene resin | Nose band: Steel wire coated<br>with Polyethylene resin | |
| | Ear loop: Nylon | Ear loop: Spandex<br>Tie strip: Polypropylene<br>Spunbond | |

### ● Comparison Table

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Image /page/6/Picture/0 description: The image shows a logo for Taiwan Chamber. The logo consists of a circular design with a horizontal line through the middle and a green leaf shape in the center. To the right of the circular design, there is text in Chinese characters, followed by the words "TAIWAN CHAMB" in smaller, gray font.

No.55, Aly. 51, Ln. 50, Daren Rd., Taoyuan Dist., Taoyuan City, TAIWAN Tel: [phone], Fax: [phone]

| | | Website: https://taiwan-champ.com/ |
|--|--|------------------------------------|
|--|--|------------------------------------|

| Anti-Fog function | No | Yes | Different |
|----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|-----------|
| Dimensions | Length: 175±5 mm<br>Width: 95 ±5 mm | Length: 165±5 mm<br>Width: 95 ±2 mm | Similar |
| Mask style | Flat pleated | Flat pleated | Same |
| Design features | Ear-loop | Ear-loop & Tie-on | Similar |
| Differential Pressure<br>(Delta-P) Test (mm<br>H2O/cm2), complying<br>with<br>EN 14683:2019+<br>AC:2019 (E), Annex C | < 5 mmH2O/cm2<br><br>Per ASTM F2100-20, Section 9.2, criteria: < 6 mmH2O/cm2 | ≤ 2.8 mmH2O/cm2<br><br>Per ASTM F2100-20, Section 9.2, criteria: < 6 mmH2O/cm2 | Same |
| Resistance to<br>penetration by synthetic<br>blood (mm Hg),<br>complying with<br>ASTM F1862/F1862M-<br>17 | No penetration at 160 mmHg<br><br>Per ASTM F2100-20, Section 9.4, criteria: no penetration at 160 mmHg | No penetration at 160 mmHg<br><br>Per ASTM F2100-20, Section 9.4, criteria: no penetration at 160 mmHg | Same |

| Particulate Filtration Efficiency at 0.1 micron (%) complying with ASTM F2299/F2299M-03(2017) | ≥ 99.8%<br>Per ASTM F2100-20, section 9.3, criteria: ≥ 98% | ≥ 99.72%<br>Per ASTM F2100-20, section 9.3, criteria: ≥ 98% | Same |
|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------|---------|
| Flammability test, complying with 16 CFR Part 1610 | Class I (Did Not Ignite)<br>Per ASTM F2100-20, Section 9.5, criteria: Class 1 | Class 1 (Ignited but Extinguished)<br>Per 16 CFR Part 1610, criteria: Class 1 | Similar |
| Bacterial Filtration Efficiency (%), complying with ASTM F2101-19 | ≥ 99.8%<br>Per ASTM F2100-20, Section 9.1, criteria: ≥ 98% | ≥ 99.5 %<br>Per ASTM F2100-20, Section 9.1, criteria: ≥ 98% | Same |

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Image /page/7/Picture/0 description: The image shows the logo for Taiwan Champ. The logo consists of a stylized letter "C" in purple, with a green leaf-like shape inside. To the right of the "C" is the text "台灣康匠 TAIWAN CHAMP" in gray. The text is stacked, with "台灣康匠" on top and "TAIWAN CHAMP" below.

No.55, Aly. 51, Ln. 50, Daren Rd., Taoyuan Dist., Taoyuan City, TAIWAN Tel: [phone], Fax: [phone] Website: https://taiwan-champ.com/

#### ● Nonclinical performance testing

Provided below is a summary of the nonclinical testing that was performed with the subject devices to demonstrate that the device met the acceptance criteria of the standard and test methodology listed below. Each test was performed using 3 nonconsecutive lots of 32 for a total of 96 samples.

| Item | Test method<br>(Performance Level 3) | Purpose | Acceptance criteria | Test results /<br>Verdict |
|------|-----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|-----------------------------------------|
| 1 | EN<br>14683:2019+AC:<br>2019(E), Annex C | Evaluate the mask's<br>resistance to airflow<br>across the face mask<br>Differential pressure<br>(Delta-P) | ASTM F2100-20,<br>Section 9.2: < 6 mm<br>H₂O/cm² | < 5 mm H₂O/cm² /<br>Pass |
| 2 | ASTM F1862/F1862M-<br>17 | Evaluate the<br>mask's resistance<br>to penetration by<br>synthetic blood | ASTM F2100-20,<br>Section 9.4, No<br>penetration at 160<br>mmHg | No penetration at<br>160 mmHg /<br>Pass |
| 3 | ASTM<br>F2299/F2299M-03<br>(2017) | Evaluate the<br>efficiency of material<br>used in medical face<br>masks to penetration<br>by<br>particulates using<br>latex spheres | ASTM F2100-20,<br>Section 9.3, ≥ 98% | ≥ 99.8 % /<br>Pass |
| 4 | 16 CFR Part 1610<br>(as amended in 2008) | Evaluate the mask's<br>flammability when<br>exposed to a direct source<br>of ignition | ASTM F2100-20,<br>Section 9.5, Class 1 | Class 1 /<br>Pass |
| 5 | ASTM F2101-19<br>Bacterial filtration<br>efficiency (BFE) | Evaluate the<br>efficiency of material<br>used in medical face<br>masks to penetration<br>by bacterial<br>organisms | ASTM F2100-20,<br>Section 9.1, ≥ 98% | $\ge$ 99.8 % /<br>Pass |

#### ● Biocompatibility Testing

According to ISO 10993-1:2018, Table A.1, the nature of body contact for the subject device is Surface Device category, Skin Intact Contact, and duration of contact is A-Limited duration (less than 24 hours). Under these categorizations, it is necessary to conduct the following testing to address the Cytotoxicity, Sensitization and Irritation effects. Thus, we provide the following test reports for the subject device to demonstrate that it is biocompatible with human body and safe for its intended use,

- In vitro Cytotoxicity Test per ISO 10993-5:2009 Biological evaluation of 1)

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Image /page/8/Picture/0 description: The image contains a logo with a circular design on the left and text on the right. The circular design features a purple outline with a horizontal purple line across the middle and a green leaf shape inside. To the right of the logo, there is text in Chinese characters above the words "TAIWAN CHAM". The text and logo appear to represent a Taiwanese organization or company.

No.55, Aly. 51, Ln. 50, Daren Rd., Taoyuan Dist., Taoyuan City, TAIWAN Tel: [phone], Fax: [phone] Website: https://taiwan-champ.com/ medical devices- Part 5: Tests for in vitro cytotoxicity,

- Irritation Test per ISO 10993-10:2010 Biological evaluation of medical 2) devices-Part 10: Tests for irritation and skin sensitization,
- 3) Skin Sensitization Test per ISO 10993-10:2010 Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization,

### ● Conclusions

The conclusions drawn from the nonclinical tests demonstrate that the subject device, Taiwan Comfort Champ Surgical Face Mask (K212863), is as safe, as effective, and performs as well as or better than the legally marketed (predicate) device, Modern Healthcare Corp Motex Anti-Fog Surgical Face Mask, (K201549)