Surgical Masks, Model:FE-1

K210767 · Hunan Triplex Precision Medical Devices Co., Ltd. · FXX · Jun 10, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K210767
• Device Name: Surgical Masks, Model:FE-1
• Applicant: Hunan Triplex Precision Medical Devices Co., Ltd.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Jun 10, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The Surgical 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

Flat-pleated surgical mask; three-layer construction; ear-loop design; integrated nose piece for facial fit. Outer/inner layers: double spun-bonded polypropylene; middle layer: melt-blown polypropylene filter. Single-use, disposable, non-sterile. Used in clinical settings or general use for infection control. Protects wearer and patient from fluid/particulate transfer. No electronic components or software.

Clinical Evidence

No clinical data. Bench testing only: ASTM F1862M-17 (fluid resistance), ASTM F2299 (particulate filtration), ASTM F2101-19 (bacterial filtration), EN 14683:2019 (differential pressure), and 16 CFR 1610 (flammability). All tests passed.

Technological Characteristics

Three-layer flat-pleated mask. Materials: Spun-bonded polypropylene (inner/outer), melt-blown polypropylene (filter). Ear loops: Polyester/spandex. Nose piece: Iron wire covered by polypropylene. Dimensions: 17.5cm x 9.5cm. Biocompatibility per ISO 10993. Performance meets ASTM F2100-19 Level 3.

Indications for Use

Indicated for use by patients and healthcare personnel to protect against transfer of microorganisms, body fluids, and particulate material; intended for infection control to reduce exposure to blood and body fluids.

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

• Surgical Face masks (Ear loops and Tie-on) (K160269)

Submission Summary (Full Text)

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June 10, 2021

Hunan Triplex Precision Medical Devices Co., Ltd % Amber Pang Director Landlink Healthcare Technology (Shanghai) Co., Ltd. Room 703, 705, Building 1, West Guangzhong Road 555, Shanghai, 200072 China

Re: K210767

Trade/Device Name: Surgical Masks, Model:FE-1 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: March 9, 2021 Received: March 15, 2021

Dear Amber Pang:

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 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.

Ryan Ortega, PhD Acting 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) K210767

Device Name Surgical Masks

#### Indications for Use (Describe)

The Surgical 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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# Section 3-510(k) Summary

### l. Submitter

Hunan Triplex Precision Medical Devices Co., Ltd. Room 612 & 613, Building No.5~8, SUNVO Health & Medicine Industrial Park, No.1048 Zhongqing Road, Kaifu District, Changsha, Hunan, China

Establishment Registration Number: 3017420299

Contact person: Huangkai Position: Manager Tel.: [phone] Fax: [phone] E-mail: [e-mail]

Preparation date: Jun. 01, 2021

### II. Proposed Device

| Trade Name of Device: | Surgical Masks |
|-----------------------|------------------|
| Common name: | Surgical Mask |
| Regulation Number: | 21 CFR 878.4040 |
| Regulatory Class: | Class II |
| Product code: | FXX |
| Review Panel | General Hospital |

### III. Predicate Devices

| 510(k) Number: | K160269 |
|-----------------|--------------------------------------------|
| Trade name: | Surgical Face masks (Ear loops and Tie-on) |
| Common name: | Surgical Mask |
| Classification: | Class II |
| Product Code: | FXX |
| Manufacturer | San-M Package Co., Ltd. |

### IV. Device Description

The Surgical Masks are Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all have Nose Piece design for fitting the face mask around the nose. The

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Medical Procedure Masks are manufactured with three layers. The outer layer is made of double spun-bonded polypropylene (PP) non-woven fabric. The middle layer with filtration function is made of melt blown polypropylene (PP) non-woven fabric. The inner layer which contacts with face is made of double spun-bonded polypropylene (PP) non-woven fabric.

The Surgical Masks are single use, disposable device, provided non-sterile.

### V. Indication for Use

The Surgical 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.

## VI. Comparison of Technological Characteristics with the Predicate Devices

| Item | Proposed Device | Predicate Device<br>(K160269) |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Surgical Masks | Surgical Face masks (Ear<br>loops and Tie-on) |
| Product Code | FXX | FXX |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 |
| Class | Class II | Class II |
| Mask Style | Flat-pleated, ear loops,<br>3 layers | Flat-pleated, ear loops or<br>tie-on, 4 layers |
| Indication for<br>Use | The Surgical Masks are<br>intended to be worn to protect<br>both the patient and healthcare<br>personnel from transfer of<br>microorganisms, body fluids<br>and particulate material. These<br>face masks are intended for<br>use in infection control<br>practices to reduce the<br>potential exposure to blood<br>and body fluids. This is a single<br>use, disposable device(s), | The Surgical facemasks are<br>intended to be worn to protect<br>the patient and healthcare<br>personnel from transfer of<br>microorganisms, blood fluid,<br>and particulate material. These<br>face masks are intended for<br>use in infection control<br>practices to reduce the<br>potential exposure to blood<br>and body fluid. This is a<br>single-use, disposable devices |

Table 10-1 General Comparison

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| | | provided non-sterile. | provided non-sterile. |
|--------------|---------------------|----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Mat<br>erial | Inner<br>layer | White double spun-bond<br>polypropylene | Polypropylene |
| | Middle<br>layer | Melt blown polypropylene filter | 1. Polypropylene spun-bond<br>2. Polypropylene melt blown |
| | Outer<br>layer | Blue double spun-bond<br>polypropylene | Polypropylene |
| | Ear loops | 85% Polyester +15% Spandex<br>3.0 Latex – free white elastic<br>band | Ear loops: Polyester, polyurethane;<br>Side tapes: Polyester spun-bond (ear loops mask only)<br>Ties tapes: Polypropylene spun-bond or polyester spun-bond |
| | Nose<br>piece | Iron wire covered by<br>polypropylene | Polyethylene coated<br>steel wire |
| | Color | Blue | Blue ,white |
| | Dimension | 17.5cmx9.5cm | 17.5cmx9.0cm<br>18.0cmx9.0cm |
| | OTC Use | Yes | Yes |
| | Sterile | Non-sterile | Non-sterile |
| | For single Use | Yes | Yes |
| | ASTM F2100<br>Level | Level 3 | Level 1, Level 2, Level 3 |
| | Biocompatibility | Confirm to the requirements of<br>ISO 10993 series standards | Confirm to the requirements of<br>ISO 10993 series standards |

# VII. Non-Clinical Testing

Non clinical performance tests were conducted to verify that the proposed device met all design specifications. The below table shows the test results of test article, which demonstrated that the proposed device complies with the standards of ASTM F2100-19:

| Methodology | Purpose | Acceptance Criteria | Results |
|----------------|---------------------------------|---------------------------------|-----------------|
| ASTM F1862M-17 | Fluid Resistance<br>Performance | 29 out of 32 pass<br>at 160mmHg | Pass at 160mmHg |
| ASTM F2299 | Particulate Filtration | $\geq$ 98% | Pass |

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| | | Efficiency | | |
|---------------|------------------------------------|--------------------------|----------------|------|
| ASTM F2101-19 | Bacterial Filtration<br>Efficiency | ≥98% | | Pass |
| EN<br>Annex C | 14683:2019 | Differential<br>Pressure | < 6.0mmH2O/cm² | Pass |
| 16 CFR 1610 | Flammability | Class I non<br>flammable | | Pass |

### VIII. Clinical Testing

No clinical study is included in this submission.

### IX. Conclusion

The conclusion drawn from the non-clinical performance testing data demonstrates that the subject device is as safe, as effective, and performs as well as or better than the predicate device, Surgical Face masks (K160269).