Surgical Face Masks

K202708 · Intco Medical(Hk) Co., Ltd. · FXX · Mar 30, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K202708
• Device Name: Surgical Face Masks
• Applicant: Intco Medical(Hk) Co., Ltd.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Mar 30, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

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 masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

Device Story

Surgical Face Mask is a single-use, disposable, non-sterile, flat-pleated mask. Construction consists of multi-layer polypropylene (outer/inner spunbond layers sandwiching a meltblown filter layer), a malleable aluminum nosepiece, and polyester/Lycra ear loops. Worn by healthcare personnel and patients in clinical settings to provide a physical barrier against microorganisms, body fluids, and particulates. Device functions as a passive barrier; no active components or software. Performance verified via bench testing for fluid resistance, filtration efficiency (BFE/PFE), differential pressure, flammability, and biocompatibility.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against ASTM F2100, ASTM F1862 (fluid resistance at 80 mmHg), ASTM F2299 (PFE >99%), ASTM F2101 (BFE >99%), EN 14683 (differential pressure <5.0 mmH2O/cm²), 16 CFR 1610 (flammability Class 1), and ISO 10993 (biocompatibility).

Technological Characteristics

Multi-layer polypropylene (spunbond/meltblown/spunbond) construction. Malleable aluminum nosepiece. Polyester/Lycra ear loops. Flat-pleated style. Non-sterile. ASTM F2100 Level 1 compliant. Biocompatibility per ISO 10993-5 and ISO 10993-10.

Indications for Use

Indicated for use by patients and healthcare personnel to protect against transfer of microorganisms, body fluids, and particulate material, and to reduce 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

• Medical Mask (K201729)

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). 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.

March 30, 2021

Intco Medical(HK) Co., Ltd. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K202708

Trade/Device Name: Surgical Face Masks Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: March 19, 2021 Received: March 22, 2021

#### Dear Prithul Bom:

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 (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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For 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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K202708

Device Name Surgical Face Mask

Indications for Use (Describe)

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 masks are intended for use in infection control practices to reduce the potential exposure of the wearer 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)

#### 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}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo and address of INTCO Medical (HK) Co., Ltd. The logo features the company name in blue, with a stylized graphic of a sun or flower above it. The address is listed as Flat/RM 19c, Lockhart Centre 301-307 Lockhart road, Wan Chai, Hong Kong.

# K202708

# 510(K) SUMMARY

# 1. Submitter's Identification:

INTCO Medical (HK) Co., Ltd. Flat/RM 19c, Lockhart Centre 301-307 Lockhart road, Wan Chai, Hong Kong

### Contact Person:

Max Li Product Manager Phone number: 86-511-83174088 Fax: [phone] Email: [e-mail]

# Date summary prepared:

March 30, 2021

- 2. Device Name: Surgical Face Masks Trade Name: Surgical Face Mask
- 3. Device Classification Name: Mask, Surgical (21 CFR 878.4040) Device Classification Panel: General Hospital
- 4. Device Class: Class II
- 5. Product Code: FXX Mask, Surgical

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

#### 6. Predicate Device:

- Zhende Medical Co., Ltd. ● Medical Mask(K201729)
#### 7. Reason for 510(k) Submission:

New device.

### 8. Device Description:

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 masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

The surgical face masks are single use multi-laver masks with outer laver and inner laver of polypropylene spunbond that sandwich a meltblown polypropylene filter material. The surgical face mask includes malleable aluminum nosepiece that can be bent to contour the nose. The surgical face masks are held in place with ear loops made of polyester/Lycra.

# 9. Intended Use/Indications for Use:

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 masks are intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.

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

| Feature | (Proposed Device)<br>Surgical Face Masks | (Predicate Device)<br>K201729 | Remarks |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| 510(K) # | Proposed Device<br>K202708 | K201729 | Proposed device is<br>same as or similar to<br>the primary predicate |
| Manufacturer | INTCO Medical<br>(HK) Co., Ltd. | Zhende Medical Co<br>Ltd. | NA |
| Common Name | Surgical Face Mask | Medical Mask | Common name of the<br>proposed device is<br>similar to the predicate<br>device |
| Classification | Class II | Class II | Device class of the<br>proposed device is the<br>same as the predicate<br>device |
| Product Code | FXX | FXX | Product code of the<br>proposed device is the<br>same as the predicate<br>device |
| Intended Use | Surgical Face Masks<br>are intended to be worn<br>to protect both the<br>patient and healthcare<br>personnel from transfer<br>of microorganisms,<br>body fluids and<br>particulate material.<br>These face masks are<br>intended for use in<br>infection control<br>practices to reduce the<br>potential exposure of<br>the wearer to blood and | The Medical Masks are<br>intended to be worn to<br>protect both the patient<br>and healthcare<br>personnel from transfer<br>of microorganisms,<br>body fluids and<br>particulate material.<br>These face masks are<br>intended for use in<br>infection control<br>practices to reduce the<br>potential exposure of<br>the wearer to blood and<br>body fluids. This is a | The intended use of the<br>proposed device is the<br>same as the predicate<br>device. |
| | body fluids. This is a<br>single use, disposable<br>device(s), provided<br>non-sterile. | single use, disposable<br>device(s), provided<br>non-sterile. | |
| Materials | | | |
| Outer Layer | Polypropylene<br>Spunbond<br>Color: Blue | Spun-bond<br>Polypropylene<br>Color: Blue | Materials of the<br>proposed device are the<br>same as or similar to<br>the predicate device |
| Inner Layer | Polypropylene<br>Spunbond | Spun-bond<br>Polypropylene | |
| Filter Media Layer | Polypropylene<br>Meltblown | Melt Blown<br>Polypropylene filter | |
| Ear Loops | Ear loops:<br>Polyester/lycra knitted<br>Diameter: 0.3 cm<br>Length: 17.5 cm. | Ear loops:<br>Polyester/Spandex | |
| Nosepiece | Malleable aluminum<br>strip<br>Width: 0.3 cm<br>Length: 10 cm | Malleable<br>polypropylene with iron<br>wire | |
| Specifications and<br>Dimensions | Length: 165 ± 19 mm<br>Width: 102 ± 19 mm | Length: 180 ± 10 mm<br>Width: 95 ± 10 mm | Specifications and<br>dimensions of the<br>proposed device are<br>similar to the predicate<br>device |
| Mask Style | Flat pleated | Flat pleated | The mask style of the<br>proposed device is the<br>same as the predicate<br>device |
| Sterility | Non-sterile | Non-sterile | The proposed product<br>and predicate device are<br>non-sterile. |
| ASTM F2100<br>Level | Level 1 | Level 1 | The proposed product<br>and predicate device<br>have the same ASTM<br>F2100 Level |
| Performance<br>Testing<br>(Completed) | | | |
| Fluid Resistance | Fluid Resistant at 80<br>mmHg<br>Lot 20201013 31/32<br>Passed 80 mmHg<br>Lot 20201022 32/32<br>Passed 80 mmHg<br>Lot 20201105 32/32<br>Passed 80 mmHg<br>ASTM F1862 | Fluid Resistant at 80<br>mmHg<br>ASTM F1862 | Fluid resistant<br>performance of the<br>proposed device is the<br>same as the predicate<br>device |
| Particulate Filtration<br>Efficiency (PFE) | Lot 20201013 32/32<br>PASSED 99.866%<br>Lot 20201022 32/32<br>PASSED 99.9784%<br>Lot 20201105 32/32<br>PASSED 99.9879%<br>ASTM F2299 | ≥ 95%<br>ASTM F2299 | Particulate Filtration<br>Efficiency performance<br>of the proposed device<br>is similar to the<br>predicate device |
| Bacterial Filtration<br>Efficiency (BFE) | Lot 20201013 32/32<br>PASSED 99.9%<br>Lot 20201022 32/32<br>PASSED 99.9%<br>Lot 20201105 32/32<br>PASSED 99.9%<br>ASTM F2101 | ≥ 95%<br>ASTM F2101 | Bacterial Filtration<br>Efficiency performance<br>of the proposed device<br>is similar to the<br>predicate device |
| Differential Pressure | < 5.0mmH2O/cm²<br>Lot 20201013<br>Average 3.9<br>mmH2O/cm²<br>Lot 20201022 | < 5.0mmH2O/cm²<br>EN 14683 Annex C | Differential Pressure<br>performance of the<br>proposed device is the<br>same as the predicate<br>device |
| | | | |
| | Average 3.9<br>mmH2O/cm²<br>Lot 20201105<br>Average 4.2<br>mmH2O/cm²<br>EN 14683 Annex C | | |
| Flammability | Class 1<br>Lot 20201013 IBE<br>Lot 20201022 IBE<br>Lot 20201105 IBE<br>16 CFR 1610 | Class 1<br>16 CFR 1610 | Flammability<br>performance of the<br>proposed device is the<br>same as the predicate<br>device |
| | | | |
| | | | |
| | | | |
| Biocompatibility | Under the conditions of<br>the study, the device is<br>non-cytotoxic<br>ISO 10993-5<br>Under the conditions of<br>the study, the device is<br>non-sensitizing<br>ISO 10993-10<br>Under the conditions of<br>the study, the device is<br>non-irritating<br>ISO 10993-10 | No cytotoxicity<br>ISO 10993-5<br>No sensitization<br>ISO 10993-10<br>No Irritation<br>ISO 10993-10 | Biocompatibility<br>performance of the<br>proposed device is the<br>same as the predicate<br>device |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |
| | | | |

10. Comparison between the device and predicate device:

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

{7}------------------------------------------------

{8}------------------------------------------------

# 11. Non-Clinical Tests Performed

ASTM 2100, Standard Specification for Performance of Materials Used in Medical Face Masks

ASTM F1862, Standard Test Method for Resistance of Medical Face Masks To Penetration by Syntehtic Blood (Horizontal Projection of Fixed Volume At A Known Velocity);

ASTM F2299, Standard test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres;

ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus Aureus;

EN 14683 Annex C, Medical Face Masks - Requirements and Test Methods;

16 CFR 1610, Standard for Flammability of clothing textiles;

ISO 10993-5: 2009 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity

ISO 10993-10: 2010 Biological Evaluation of Medical Devices – Part 10: Tests for Irritation And Skin Sensitization

#### 12. Clinical Test Performed

No clinical testing was performed.

{9}------------------------------------------------

#### 13. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K202708, FXX, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K201729.