Surgical Face Masks (Ear loops and Tie-on)

K160269 · San-M Package Co., Ltd. · FXX · Sep 6, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K160269
• 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 6, 2016
• Decision: SESE
• Submission Type: Abbreviated
• 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 the potential exposure to blood and body fluids. This is a single-use, disposable device, provided non-sterile.

Device Story

Four-layer, flat-pleated, non-sterile, single-use, disposable surgical face masks; constructed of nonwoven polypropylene; available with ear loops (polyester/polyurethane) or tie-on tapes (polypropylene/polyester); includes malleable nosepiece for fit; optional integrated polyester visor. Used in clinical settings by healthcare personnel to provide barrier protection against microorganisms, body fluids, and particulates; reduces potential exposure to blood and body fluids for both wearer and patient.

Clinical Evidence

Bench testing only. Performance evaluated against ASTM F2100-11 standards: fluid resistance (ASTM F1862), particulate filtration efficiency (ASTM F2299), bacterial filtration efficiency (ASTM F2101), differential pressure (MIL-M36945C), and flammability (16 CFR 1610). Biocompatibility testing performed per ISO 10993 (cytotoxicity, irritation, sensitization).

Technological Characteristics

Four-layer nonwoven polypropylene construction; flat-pleated design; ear loops (polyester/polyurethane) or tie-on tapes (polypropylene/polyester); malleable nosepiece. Conforms to ASTM F2100-11, ASTM F1862, ASTM F2299, ASTM F2101, MIL-M36945C, 16 CFR 1610, and ISO 10993. Non-sterile, single-use.

Indications for Use

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

• Kimberly-Clark KC100 Mask (K110455)
• Kimberly-Clark KC200 Face Mask (K111402)
• Kimberly-Clark KC300 Face Mask (K111402)

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines extending from the profiles.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 6, 2016

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

Re: K160269

Trade/Device Name: Surgical Face Masks (Ear loops and Tie-on) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: August 2, 2016 Received: August 4, 2016

Dear Mr. 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. 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 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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

the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

# Indications for Use

510(k) Number (if known) K160269

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 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 nonsterile.

Level 1 Face Mask Models: # EL 10000. EL 10010. TO 10000. TO 10010 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)

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) Owner/<br>Applicant | SAN-M PACKAGE CO., LTD.<br>1086-1 Ojiro<br>Shimada-City Sizuoka, JAPAN 428-8652 |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K160269 |
| US Correspondent | Takahiro Haruyama<br>Globizz Corporation<br>[phone]<br>[e-mail] |
| Date Prepared | August 30, 2016 |
| Trade Name | Surgical Face Masks (Ear loops and Tie-on) |
| Common Name | Surgical Mask |
| Classification Name | Masks, Surgical |
| Review Panel | General & Plastic Surgery |
| Product Code | FXX |
| Device Classification | Class II per 21 CFR §878.4040 |
| Predicate Device | The Surgical Face Masks (Ear loops and Tie-on) are substantially equivalent to the Kimberly-Clark KC100 Mask (K110455) and KC200 and KC300 Face Masks (K111402). A comparison between the proposed and predicate devices is shown in Table 5-A below. |

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

Table 5-A. Comparison of characteristics.

| Feature | (Proposed Device)<br>Surgical Face Masks<br>(Ear loops and Tie-on) | | | (Predicate Device) | | |
|------------------------|--------------------------------------------------------------------|------------|------------|--------------------------|-------------------------------|-------------------------------|
| | Level<br>1 | Level<br>2 | Level<br>3 | KC100 Mask<br>Level<br>1 | KC200 Face Mask<br>Level<br>2 | KC300 Face Mask<br>Level<br>3 |
| <b>510(k) #</b> | K160269 | | | K110455 | K111402 | |
| <b>Manufacturer</b> | San-M Package Co.,<br>Ltd. | | | Kimberly-Clark | | |
| <b>Common<br/>Name</b> | Surgical Mask | | | Surgical Mask | | |

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

| Classification | Class II | Class II | Class II | |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Product Code | FXX | FXX | FXX | |
| Intended Use | The 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 to<br>blood and body fluids.<br>This is a single-use,<br>disposable device,<br>provided non-sterile. | The Kimberly-<br>Clark KC100<br>Procedure<br>Mask(s) is<br>intended to be<br>worn to protect<br>both the patient<br>and healthcare<br>personnel from<br>transfer of<br>microorganisms,<br>body fluids, and<br>particulate<br>material. These<br>face masks are<br>intended for use<br>in infection<br>control practices<br>to reduce the<br>potential<br>exposure of the<br>wearer to blood<br>and body fluids.<br>The Kimberly-<br>Clark KC100<br>Procedure<br>Mask(s) is a<br>single use,<br>disposable<br>devices,<br>provided non-<br>sterile. | The Kimberly-Clark, KC200<br>and KC300 Face Mask(s) is<br>intended to be worn to protect<br>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 to<br>reduce the potential exposure<br>of the wearer to blood and<br>body fluids. The Kimberly-<br>Clark, KC200 and KC300<br>face mask(s) is a single use,<br>disposable device(s), provided<br>non-sterile. | |
| Materials | | | | |
| Outer<br>Material | Polypropylene | Polypropylene<br>spunbond | Polyester<br>cellulose | Polypropylene<br>spunbond |
| Inner<br>Material | Polypropylene | Polyethylene/<br>Polyester | Polyester cellulose | |
| Filter Media | 1. Polypropylene<br>spunbond<br>2. Polypropylene<br>meltblown | 1. Polypropy-<br>lene<br>meltblown | 1. Polypropylene spunbond<br>2. Polypropylene meltblown | |
| Nose Clamp | | N/A | N/A | |
| Ear Loops/<br>Tie Tapes | Ear loops: Polyester, polyurethane<br>Side tapes:<br>Polyester spunbond (ear loops mask only)<br><br>Tie tapes:<br>Polypropylene spunbond or polyester spunbond | Ear loops:<br>Polyester/lycra knitted<br><br>Tie tapes:<br>Polyester spunlace | Ear loops:<br>Polyester/lycra knitted<br><br>Tie tapes:<br>Polyester spunlace | |
| Design<br>Features | Colors: white or blue Visor option: polyester | Colors: variety Visor option | Colors: variety Visor option | |
| Specifications<br>and<br>Dimensions | Length: $90 \pm 3$ mm<br>Width: $175 \pm 5$ mm | Length: $90 \pm 3$ mm<br>Width: $180 \pm 5$ mm | Length: $102 \pm 19$ mm<br>Width: $165 \pm 19$ mm | |
| Mask Style | Flat-pleated | Flat-pleated | Flat-pleated | |
| Sterility | Non-sterile | Non-sterile | Non-sterile | |
| Performance<br>Testing<br>(ASTM<br>F2100-11) | Level 1 | Level 2 | Level 3 | |
| Fluid<br>Resistance | ASTM F1862 | ASTM F1862 | ASTM F1862 | |
| Particulate<br>Filtration<br>Efficiency | ASTM F2299 | ASTM F2299 | ASTM F2299 | |
| Bacterial<br>Filtration<br>Efficiency | ASTM F2101 | ASTM F2101 | ASTM F2101 | |
| Differential<br>Pressure | MIL-M36945C | MIL-M36945C | MIL-M36945C | |
| Flammability | 16 CFR 1610 | 16 CFR 1610 | 16 CFR 1610 | |
| Biocompat-<br>ibility | ISO 10993 | ISO 10993 | ISO 10993 | |

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

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

| 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 or blue and with the option for a visor. The surgical face masks are single-use, disposable devices, provided non-sterile. |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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

| | Table 5-B. Surgical Face Mask Model Numbers | | |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|----------|
| | Mask Style | Ear Loops | Tie-On |
| | Level 1 | EL 10000 | T0 10000 |
| | Level 1 with Visor | EL 10010 | T0 10010 |
| | Level 2 | EL 20000 | T0 20000 |
| | Level 2 with Visor | EL 20010 | T0 20010 |
| | Level 3 | EL 30000 | T0 30000 |
| | Level 3 with Visor | EL 30010 | T0 30010 |
| Technological<br>Characteristics | The Surgical Face Masks (Ear loops and Tie-on) are substantially<br>equivalent to the current legally marketed predicated devices<br>cleared in K110455 and K111402. The product conforms to the<br>recognized standards ASTM F2100-11, ASTM F1862, ASTM<br>F2101, and ISO 10993 in addition to the requirements stated in the<br>Guidance for Industry and FDA Staff: Surgical Masks-Premarket<br>Notifications [510(k)] Submissions, issued March 5, 2004. | | |
| Performance &<br>Biocompatibility | The Surgical Face Masks (Ear loops and Tie-on) have been tested<br>according to the Guidance for Industry and FDA Staff: Surgical | | |

Testing

Masks-Premarket Notifications [510(k)] Submissions, issued March 5, 2004.

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

## Performance & Biocompatibility Testing (continued)

| | (Proposed Device)<br>Surgical Face Masks (Ear loops and<br>Tie-on) | | | (K110455)<br>KC100<br>Mask | (K111402)<br>KC 200<br>Face Mask<br>KC 300<br>Face Mask | |
|----------------------------------|-------------------------------------------------------------------------------|------------------------------|------------------------------|------------------------------------------------------------------------------------|--------------------------------------------------------------------------|------------------------------|
| TEST | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 |
| ASTM<br>F2100-11 | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 |
| ASTM<br>F1862 | Pass at 80<br>mmHg | Pass at 120<br>mmHg | Pass at 160<br>mmHg | Pass at 80<br>mmHg | Pass at 120<br>mmHg | Pass at 160<br>mmHg |
| ASTM<br>F2299 | Pass at<br>99.6% | Pass at<br>99.6% | Pass at<br>99.7% | Pass at<br>98.4% | Pass at<br>98.4% | Pass at<br>98.4% |
| ASTM<br>F2101 | Pass at<br>>98% | Pass at<br>>98% | Pass at<br>>99% | Pass at<br>99.7% | Pass at<br>99.7% | Pass at<br>99.7% |
| MIL-<br>M36945C | Pass at 2.0<br>mmH2O/cm<br>2 | Pass at 1.6<br>mmH2O/cm<br>2 | Pass at 2.5<br>mmH2O/cm<br>2 | Pass at 3.0<br>mmH2O/cm<br>2 | Pass at 4.5<br>mmH2O/cm<br>2 | Pass at 3.2<br>mmH2O/cm<br>2 |
| 16 CFR<br>1610 | Class 1 | Class 1 | Class 1 | Class 1 | Class 1 | Class 1 |
| Cytotoxicity<br>ISO<br>10993-5 | Under the conditions of the study, the<br>subject device was non-cytotoxic. | | | Under the<br>conditions<br>of the study,<br>the device<br>was non-<br>cytotoxic. | Under the conditions of<br>the study, the device was<br>non-cytotoxic. | |
| Irritation<br>ISO<br>10993-10 | Under the conditions of the study, the<br>subject device was non-irritating. | | | Under the<br>conditions<br>of the study,<br>the device<br>was non-<br>irritating. | Under the conditions of<br>the study, the device was<br>non-irritating. | |
| Sensitization<br>ISO<br>10993-10 | Under the conditions of the study, the<br>subject device was non-sensitizing. | | | Under the<br>conditions<br>of the study,<br>the device<br>was non-<br>sensitizing. | Under the conditions of<br>the study, the device was<br>non-sensitizing. | |

| | | Table 5-C. Comparison of performance and biocompatibility testing. | | |
|--|--|--------------------------------------------------------------------|--|--|
|--|--|--------------------------------------------------------------------|--|--|

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

### Conclusions

The product proposed under this premarket notification submission is similar in design, intended use, technological characteristics, and is composed of the same or similar components as the predicate device. The product proposed under this premarket notification submission has the same or similar performance characteristics and conform to the same or similar standards. Differences between the Surgical Face Masks (Ear loops and Tie-on) and predicate devices did not raise any new concerns regarding safety and effectiveness. The conclusions drawn from the non-clinical tests demonstrate that the device is substantially equivalent to the predicate devices K110455 and K111402.