Medical surgical mask

K210380 · Shantou T&K Medical Equipment Factory Co.,Ltd · FXX · Jul 8, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K210380
• Device Name: Medical surgical mask
• Applicant: Shantou T&K Medical Equipment Factory Co.,Ltd
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Jul 8, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The Medical surgical 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 the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.

Device Story

Medical surgical mask is a flat-pleated, three-layer, single-use, disposable face mask. It features an outer layer of blue polypropylene (PP) non-woven fabric, a middle layer of PP melt-blown non-woven fabric for filtration, and an inner white PP non-woven layer. It includes ear loops and a nose piece for facial fit. Used in clinical settings by healthcare personnel and patients to provide a physical barrier against microorganisms, body fluids, and particulates. The device is provided non-sterile and is intended to reduce exposure to blood and body fluids during infection control practices.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against ASTM F2100-19 standards, including fluid resistance (ASTM F1862M-17), particulate filtration efficiency (ASTM F2299), bacterial filtration efficiency (ASTM F2101-19), differential pressure (EN 14683:2019), and flammability (16 CFR 1610). All tests passed.

Technological Characteristics

Three-layer flat-pleated mask. Materials: Polypropylene (PP) non-woven outer/inner layers, PP melt-blown middle layer. Nose piece: PP, PE, and galvanized wire. Ear loops: Spandex. Dimensions: 17.5cm x 9.5cm. Performance: ASTM F2100 Level 3. Biocompatibility: ISO 10993 compliant. Non-sterile, single-use.

Indications for Use

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

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)

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

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: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font size.

July 8. 2021

Shantou T&K Medical Equipment Factory Co.,Ltd % Stuart Situ Director Landlink Healthcare Technology (Shanghai) Co., Ltd. Room 1308, Baohua International Plaza, West Guangzhong Road 555 Shanghai, 200071 China

Re: K210380

Trade/Device Name: Medical surgical mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 26, 2021 Received: May 28, 2021

Dear Stuart Situ:

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.

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

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, Ph.D. 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) K210380

Device Name Medical surgical mask

Indications for Use (Describe)

The Medical surgical 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 the potential exposure to blood and body fluids. 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)

X Over-The-Counter Use (21 CFR 801 Subpart C)

#### 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 PRAStaff(@fda.hhs.gov

"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}------------------------------------------------

# 510(k) Summary K210380

## I. Submitter

Shantou T&K Medical Equipment Factory Co.,Ltd No.8 Workshop, Wanji South Second Street Shantou, Guangdong CN515065

Establishment Registration Number: 3016710550

Contact person: Wan Li Position: Manager Tel.: [phone] E-mail: [e-mail]

Preparation date: July.8, 2021

# II. Proposed Device

| Trade Name of Device: | Medical surgical mask |
|-----------------------|-----------------------|
| 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 Medical surgical mask is 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 Medical surgical mask is manufactured with three layers. The outer layer is made

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

of polypropylene (PP) non-woven fabric with blue color. The middle layer is filtration function and is made of polypropylene (PP) melt-blown non-woven fabric. The inner layer contact with face is made of polypropylene (PP) non-woven fabric with white color.

The Medical surgical mask is single use, disposable device, provided non-sterile.

# V. Indication for Use

The Medical surgical 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 the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.

# VI. Comparison of Technological Characteristics with the Predicate Devices

| Item | Proposed Device (K210380) | Predicate Device (K160269) | Comparison |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Trade Name | Medical surgical mask | Surgical Face masks (Ear loops and Tie-on) | Different |
| Product Code | FXX | FXX | Same |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Class | Class II | Class II | Same |
| Mask Style | Flat-pleated, ear loops, 3 layers | Flat-pleated, ear loops or tie-on, 4 layers | Different |
| Indication for Use | The Medical 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 | The Surgical face masks are intended to be worn to protect the patient and healthcare personnel from transfer of microorganisms, blood fluid, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluid. This is a single-use, disposable devices provided non-sterile. | Similar |

Table 10-1 General Comparison

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

| single use, disposable | |
|-------------------------------|--|
| device, provided non-sterile. | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |
| | |

| Material | Inner<br>layer | | Polypropylene | Different |
|---------------------|-----------------|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| | Middle<br>layer | Polypropylene melt-<br>blown<br>non-woven fabric | 1. Polypropylene spun-bond<br>2. Polypropylene melt blown | Similar |
| | Outer<br>layer | Polypropylene<br>nonwoven | Polypropylene | Similar |
| | Ear loops | Ear loops: Spandex<br>Tie bands:<br>Polypropylene<br>nonwoven | Ear loops: Polyester, polyurethane;<br>Side tapes: Polyester<br>spun-bond (ear loops mask<br>only)<br>Ties tapes: Polypropylene<br>spun-bond or polyester<br>spun-bond | Different |
| | Nose<br>piece | PP、PE, galvanized | Polyethylene coated<br>steel wire | Different |
| Color | | Blue | Blue ,white | Different |
| Dimension | | 17.5cmx9.5cm | 17.5cmx9.0cm<br>18.0cmx9.0cm | Similar |
| OTC Use | | Yes | Yes | Same |
| Sterile | | Non-sterile | Non-sterile | Same |
| For single Use | | Yes | Yes | Same |
| ASTM F2100<br>Level | | Level 3 | Level 1: Pass at 80mmHg<br>Level 2: Pass at 120mmHg<br>Level 3: Pass at 160mmHg | Similar |

{6}------------------------------------------------

| Biocompatibility | Confirm to the<br>requirements of<br>ISO 10993 series<br>standards | Confirm to the requirements of<br>ISO 10993 series standards | Same |
|------------------|--------------------------------------------------------------------|--------------------------------------------------------------|------|
|------------------|--------------------------------------------------------------------|--------------------------------------------------------------|------|

# V. 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 (3 Lots) |
|--------------------------|--------------------------------------|---------------------------------|------------------|
| ASTM F1862M-17 | Fluid Resistance<br>Performance | 29 out of 32 pass at<br>160mmHg | Pass |
| ASTM F2299 | Particulate Filtration<br>Efficiency | ≥98% | Pass |
| ASTM F2101-19 | Bacterial Filtration<br>Efficiency | ≥98% | Pass |
| EN 14683:2019<br>Annex C | Differential Pressure | < 6.0mmH2O/cm² | Pass |
| 16 CFR 1610 | Flammability | Class I non flammable | Pass |

## VI. Clinical Testing

No clinical study is included in this submission.

## VII.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).