Surgical Face Masks (Ear Loops And Tie-On)

K221534 · San-M Package Co., Ltd. · FXX · Sep 16, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K221534
• Device Name: Surgical Face Masks (Ear Loops And Tie-On)
• Applicant: San-M Package Co., Ltd.
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Sep 16, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The 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 potential exposure to blood and body fluids. this is a single-use, disposable device, provided non-sterile. This mask is safe for use in the MR environment.

Device Story

Surgical face masks (ear loop and tie-on styles) designed for infection control; worn by healthcare personnel and patients. Four-layer, flat-folded construction using nonwoven polypropylene; includes malleable polyethylene nose clamp, polyester/polyurethane ear loops or polypropylene/polyester ties. Optional features include cup keeper (polypropylene) or visor (polyester). Single-use, disposable, non-sterile. Safe for use in MR environments. Protects against transfer of microorganisms, body fluids, and particulates. No electronic components or software.

Clinical Evidence

Bench testing only. Performance evaluated per ASTM F2100-11 standards: Fluid Resistance (ASTM F1862), Particulate Filtration Efficiency (ASTM F2299), Bacterial Filtration Efficiency (ASTM F2101), Differential Pressure (MIL-M-36954C), and Flammability (16 CFR 1610). Biocompatibility assessed per ISO 10993 (cytotoxicity, irritation, sensitization). All tests passed and demonstrated equivalence to the predicate.

Technological Characteristics

Four-layer nonwoven polypropylene construction; polyethylene nose clamp; polyester/polyurethane ear loops or polypropylene/polyester ties. Flat-pleated form factor. Non-sterile. MR safe. Performance standards: ASTM F2100-11, ASTM F1862, ASTM F2299, ASTM F2101, MIL-M-36954C, 16 CFR 1610. Biocompatibility: ISO 10993.

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 in 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

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

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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 16, 2022

San-M Package Co., Ltd. % Takahiro Haruyama President Globizz Corporation 1411 W 190th St. Toyota Plaza #200 Gardena, California 90248

Re: K221534

Trade/Device Name: Surgical Face Masks (Ear Loops And Tie-On) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: May 24, 2022 Received: May 27, 2022

Dear Takahiro Haruyama:

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 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,

Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic 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) K221534

Device Name Surgical Face Masks (Ear Loops and Tie-On)

#### Indications for Use (Describe)

The 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 potential exposure to blood and body fluids. this is a single-use, disposable device, provided non-sterile. This mask is safe for use in the MR environment.

Level 1 Face Mask Models: # EL 10000, EL 10010, TO 10000, TO10010 Level 2 Face Mask Models: # EL 20000, EL 20010, TO 20000, TO 20010 Level 3 Face Mask Models: # EL 30000, EL 30010, TO 30000, TO 30010

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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# 510(k) SUMMARY for Surgical Face Masks (Ear loops and Tie-on)

# 1. Submission Sponsor

SAN-M PACKAGE CO., LTD. 1086-1 Ojiro Shimada-City Sizuoka, Japan 428-8652

# 2. Submission Correspondent

| Name : | Takahiro Haruyama |
|----------|-------------------------------------------------|
| Title : | President, Globizz Corporation |
| Address: | 1411 W. 190th St., Ste. 200, Gardena, CA, 90248 |
| Phone: | [phone] |
| Email: | [e-mail] |

#### 3. Date Prepared

Aug 11th, 2022

### 4. Device Identification

| Type of 510(k) : | Traditional 510(k) |
|----------------------|--------------------------------------------|
| Trade Name : | Surgical Face Masks (Ear loops and Tie-on) |
| Product Code : | FXX |
| Classification Name: | Surgical Mask |
| Regulation Number : | 21 CFR §878.4040 |
| Device Class: | Class II |
| Review Panel : | General & Plastic Surgery |

#### 5. Legally Marketed Predicate Device

| Trade Name: | Surgical Face Masks (Ear loops and Tie-on) |
|----------------|--------------------------------------------|
| 510(k) Number: | K160269 |
| Manufacturer: | SAN-M PACKAGE CO., LTD. |

### 6. Indication for Use

The 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

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potential exposure to blood and body fluids. this is a single-use, disposable device, provided non-sterile. This mask is safe for use in the MR environment.

Level 1 Face Mask Models: # EL 10000, EL 10010, TO 10000, TO10010 Level 2 Face Mask Models: # EL 20000, EL 20010, TO 20000, TO 20010 Level 3 Face Mask Models: # EL 30000, EL 30010, TO 30000, TO 30010

# 7. Device Description

The Surgical Face Masks (Ear Loops and Tie-On) are four-layer, flat-folded masks constructed of nonwoven polypropylene materials. The mask is provided with ear loops (polyester and polyurethane) or ties (polypropylene/polyester). A malleable nosepiece is placed within the binding for comfort and individualized fit. The surgical face masks will be provided in white and blue, and options for added cup keeper (polypropylene), visor (polyester), or both. The surgical face masks are single-use, disposable devices, provided non-sterile. This mask is safe for use in the MR environment.

#### 8. Model Numbers

| Mask Feature | Subject Device | Predicate Device(K160269) |
|--------------------|----------------|---------------------------|
| Mask Style | Ear Loops | Ear Loops |
| Level 1 | EL 10000 | EL 10000 |
| Level 1 with Visor | EL 10010 | EL 10010 |
| Level 2 | EL 20000 | EL 20000 |
| Level 2 with Visor | EL 20010 | EL 20010 |
| Level 3 | EL 30000 | EL 30000 |
| Level 3 with Visor | EL 30010 | EL 30010 |
| Mask Style | Tie-On | Tie-On |

Table 1. Surgical Face Mask Model Comparison Table

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| Level 1 | TO 10000 | TO 10000 |
|--------------------|----------|----------|
| Level 1 with Visor | TO 10010 | TO 10010 |
| Level 2 | TO 20000 | TO 20000 |
| Level 2 with Visor | TO 20010 | TO 20010 |
| Level 3 | TO 30000 | TO 30000 |
| Level 3 with Visor | TO 30010 | TO 30010 |

#### 9. Technological Characteristics

The subject device, Surgical Face Masks (Ear Loops And Tie-On) is substantially equivalent to the legally marketed predicate device, K160269 Surgical Face Masks (Ear Loops And Tie-On). There is one major difference between these devices, which is the material of the nose clamp from polyethylene coated steel wire to just polyethylene which allows for use in MRI environments.

#### 10. Substantial Equivalence Discussion

## Table 2: Comparison of Predicate and Subject Device, Surgical Face Masks (Ear Loops and Tie-On).

| Feature | Subject Device | | | Predicate Device (160269) | | | Comparison |
|--------------|-----------------------------------------------------|---------|---------|----------------------------------------------------------------------|---------|---------|----------------------------------------------------------------------------------|
| | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | |
| Product Name | (New) Surgical Face Masks<br>(Ear Loops And Tie-On) | | | (Our approved product)<br>Surgical Face Masks (Ear loops And Tie-On) | | | Surgical Face Masks<br><br>(Ear Loops and Tie-On) is San-M's previously approved |

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| | | | product under<br>K160269. |
|------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| 510(k) Clearance | -- | K160269 | -- |
| Manufacturer | San-M Package Co., Ltd. | San-M Package Co., Ltd. | Equivalent. |
| Common Name | Surgical Mask | Surgical Mask | Equivalent. |
| Classification | Class II | Class II | Equivalent. |
| Product Code | FXX | FXX | Equivalent. |
| Intended Use | The surgical face masks are<br>intended to be worn to<br>protect both the patient and<br>healthcare personnel from<br>transfer of microorganisms,<br>body fluids, and particulate<br>material. These face masks<br>are intended for use in<br>infection control practices<br>to reduce the potential<br>exposure to blood and body<br>fluids. This is a single-use,<br>disposable device, provided<br>non-sterile. This mask is<br>safe for use in the MR<br>environment. | The surgical face masks are<br>intended to be worn to<br>protect both the patient and<br>healthcare personnel from<br>transfer of microorganisms,<br>body fluids, and particulate<br>material. These face<br>masks are intended for use<br>in infection control<br>practices to reduce the<br>potential exposure to blood<br>and body fluids. This is a<br>single-use, disposable<br>device, provided non-<br>sterile. | Additional<br>function of MR<br>safe.<br>Rest is<br>equivalent. |
| Materials | | | |
| Outer Material | Polypropylene | Polypropylene | Equivalent. |
| Inner Material | Polypropylene | Polypropylene | Equivalent. |
| Filter Media | 1.Polypropylene<br>2.Polypropylene meltblown | 1.Polypropylene<br>2.Polypropylene meltblown | Equivalent. |
| Nose Clamp | Polyethylene | Polyethylene coated steel<br>wire | Different. Steel<br>wire is removed<br>from nose<br>clamp. New |

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K221534
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| | | | | | | | material passed<br>the<br>biocompatibility tests. No<br>differences in<br>performance. |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|---------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|---------|----------------------------------------------------------------------------------------|
| Ear Loops/Tie<br>Tapes | Ear loops: Polyester,<br>polyurethane<br><br>Side tapes: Polyester<br>spunbond (ear loops mask<br>only)<br><br>Tie tapes: Polypropylene<br>spunbond or polyester<br>spunbond | | | Ear loops: Polyester,<br>polyurethane<br><br>Side tapes: Polyester<br>spunbond (ear loops mask<br>only)<br><br>Tie tapes: Polypropylene<br>spunbond or polyester<br>spunbond | | | Equivalent. |
| Design Features | •Colors: white or blue<br>•Cup keeper option:<br>polypropylene<br>•Visor option: polyester | | | •Colors: white or blue<br>•Cup keeper option:<br>polypropylene<br>•Visor option: polyester | | | Equivalent. |
| Specifications and<br>Dimensions | Length: 175<br>± 5mm<br><br>Width:<br>90 ± 3mm | Length: 180<br>± 5mm<br><br>Width:<br>90 ± 3mm | | Length: 175<br>± 5mm<br><br>Width:<br>90 ± 3mm | Length: 180<br>± 5mm<br><br>Width:<br>90 ± 3mm | | Equivalent. |
| Mask Style | Flat-pleated | | | Flat-pleated | | | Equivalent. |
| Sterility | Non-sterile | | | Non-sterile | | | Equivalent. |
| Performance<br>Testing (ASTM<br>F2100-11) | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | Equivalent. |
| Fluid Resistance | ASTM F1862 | | | ASTM F1862 | | | Equivalent. |

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| Particulate<br>Filtration<br>Efficiency | ASTM F2299 | ASTM F2299 | Equivalent. |
|-----------------------------------------|-------------|-------------|-------------|
| Bacterial Filtration<br>Efficiency | ASTM F2101 | ASTM F2101 | Equivalent. |
| Differential<br>Pressure | MIL-M36945C | MIL-M36945C | Equivalent. |
| Flammability | 16 CFR 1610 | 16 CFR 1610 | Equivalent. |
| Biocompatibility | ISO 10993 | ISO 10993 | Equivalent. |

Performance Testing:

The San-M Surgical Masks have been tested according to ASTM F2101-11.

Table 3: Comparison of performance and biocompatibility testing

| ASTM F2100-11 | Subject Device<br>San-M Surgical Masks | | | K160269 | Comparison | | |
|----------------------------------------------|----------------------------------------|--------------------------------------------------------------------------------------|------------------------------|------------------------------|----------------------------------------------------------------------------------|---------------------------------|------------|
| | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | |
| Fluid Resistance<br>(ASTM F1862) | Pass at 80 mmHg | Pass at 120 mmHg | Pass at 160 mmHg | Pass at 80 mmHg | Pass at 120 mmHg | Pass at 160 mmHg | Equivalent |
| PFE<br>(ASTM F2299):<br>$\ge 98%$ | Pass at 99.6% | Pass at 99.6% | Pass at 99.6% | Pass at 99.6% | Pass at 99.6% | Pass at 99.6 % | Equivalent |
| BFE<br>(ASTM F2101): | Pass at<br>>98% | Pass at<br>>98% | Pass at<br>>99.9 % | Pass at<br>>98% | Pass at<br>>98% | Pass<br>at<br>>99% | Equivalent |
| ≥ 98% | | | | | | | |
| Δ P<br>(MIL-M-36954C):<br><5.0 mm<br>H2O/cm² | Pass at<br>2.0 mm<br>H2O/cm² | Pass at<br>1.6 mm<br>H2O/cm² | Pass at<br>2.5 mm<br>H2O/cm² | Pass at<br>2.0 mm<br>H2O/cm² | Pass at<br>1.6 mm<br>H2O/cm² | Pass<br>at 2.5<br>mm<br>H2O/cm² | Equivalent |
| Flammability<br>(16 CFR 1610):<br>Class 1 | Class 1 | | | | Class 1 | | Equivalent |
| Cytotoxicity .<br>ISO 10993-5 | | Under the conditions of<br>the study, the subject<br>device was non-cytotoxic. | | | Under the conditions of the<br>study, the subject device was<br>non-cytotoxic. | | Equivalent |
| Irritation ISO<br>10993-10 | | Under the conditions of<br>the study, the subject<br>device was non-irritating. | | | Under the conditions of the<br>study, the subject device was<br>non-irritating. | | Equivalent |
| Sensitization ISO<br>10993-10 | | Under the conditions of<br>the study, the subject<br>device was non-<br>sensitizing. | | | Under the conditions of the<br>study, the subject device was<br>non-sensitizing. | | Equivalent |

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#### 11. Substantial Equivalence Conclusion

The subject device, Surgical Face Masks (Ear Loops and Tie-On) is substantially equivalent to the legally marketed predicate device, K160269 Surgical Face Masks (Ear Loops And Tie-On). There is one major difference between these devices, which is the material of the nose clamp from polyethylene coated steel wire to just polyethylene which allows for use in MRI environments. Therefore, we believe this device is regulated under the same regulation as K160269 Surgical Face Masks (Ear Loops and Tie-On): 21 CFR 878.4040 (Class II, Product code FXX for Masks, Surgical). The conclusions drawn for the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the identified predicate device.