Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and filtration capabilities of surgical face masks, with no mention of AI or ML.

Therapeutic

No
The device is a surgical face mask intended to protect against transferring microorganisms and fluids, not to treat a medical condition.

Diagnostic

No
A diagnostic device is used to identify a disease, condition, or injury. The provided text indicates the device (surgical face masks) is intended for protection from transfer of microorganisms and body fluids, not for diagnosis.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical product made of nonwoven polypropylene materials with ear loops or ties and a nosepiece. The performance studies and key metrics relate to the physical properties and performance of a face mask, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the masks are for protecting both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic function.
Device Description: The description details the physical construction of the mask, which is consistent with a barrier device.
Performance Studies and Key Metrics: The performance studies and metrics (Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability) are all related to the barrier and protective capabilities of the mask, not to the diagnosis of any condition.
Lack of Diagnostic Elements: There is no mention of analyzing samples (like blood, urine, tissue), detecting biomarkers, or providing information for diagnosis.

IVD devices are used to examine specimens taken from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This surgical face mask does not perform any of these functions.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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

Product codes

FXX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

healthcare personnel

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

The Surgical Face Masks (Ear loops and Tie-on) have been tested according to the Guidance for Industry and FDA Staff: Surgical Masks-Premarket Notifications [510(k)] Submissions, issued March 5, 2004. Performance tests include ASTM F1862 for Fluid Resistance, ASTM F2299 for Particulate Filtration Efficiency, ASTM F2101 for Bacterial Filtration Efficiency, MIL-M36945C for Differential Pressure, and 16 CFR 1610 for Flammability. Biocompatibility tests include Cytotoxicity (ISO 10993-5), Irritation (ISO 10993-10), and Sensitization (ISO 10993-10). All tests passed for Level 1, Level 2, and Level 3 masks.

Key Metrics

Fluid Resistance (ASTM F1862): Pass at 80 mmHg (Level 1), Pass at 120 mmHg (Level 2), Pass at 160 mmHg (Level 3)
Particulate Filtration Efficiency (ASTM F2299): Pass at 99.6% (Level 1), Pass at 99.6% (Level 2), Pass at 99.7% (Level 3)
Bacterial Filtration Efficiency (ASTM F2101): Pass at >98% (Level 1), Pass at >98% (Level 2), Pass at >99% (Level 3)
Differential Pressure (MIL-M36945C): Pass at 2.0 mmH2O/cm2 (Level 1), Pass at 1.6 mmH2O/cm2 (Level 2), Pass at 2.5 mmH2O/cm2 (Level 3)
Flammability (16 CFR 1610): Class 1 (all levels)
Cytotoxicity (ISO 10993-5): non-cytotoxic
Irritation (ISO 10993-10): non-irritating
Sensitization (ISO 10993-10): non-sensitizing

Predicate Device(s)

K110455, K111402

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 878.4040 Surgical apparel.

(a)
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.(b)
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.

Summary

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

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3

| 510(k) Owner/
Applicant | SAN-M PACKAGE CO., LTD.
1086-1 Ojiro
Shimada-City Sizuoka, JAPAN 428-8652 |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K160269 |
| US Correspondent | Takahiro Haruyama
Globizz Corporation
(310) 538-3860
register@globizz.net |
| 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)
Surgical Face Masks
(Ear loops and Tie-on) | | | (Predicate Device) | | |
|------------------------|--------------------------------------------------------------------|------------|------------|--------------------------|-------------------------------|-------------------------------|
| | Level
1 | Level
2 | Level
3 | KC100 Mask
Level
1 | KC200 Face Mask
Level
2 | KC300 Face Mask
Level
3 |
| 510(k) # | K160269 | | | K110455 | K111402 | |
| Manufacturer | San-M Package Co.,
Ltd. | | | Kimberly-Clark | | |
| Common
Name | Surgical Mask | | | Surgical Mask | | |

4

Classification	Class II	Class II	Class II
Product Code	FXX	FXX	FXX
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.	The Kimberly-
Clark KC100
Procedure
Mask(s) 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 of the
wearer to blood
and body fluids.
The Kimberly-
Clark KC100
Procedure
Mask(s) is a
single use,
disposable
devices,
provided non-
sterile.	The Kimberly-Clark, KC200
and KC300 Face Mask(s) 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
of the wearer to blood and
body fluids. The Kimberly-
Clark, KC200 and KC300
face mask(s) is a single use,
disposable device(s), provided
non-sterile.
Materials
Outer
Material	Polypropylene	Polypropylene
spunbond	Polyester
cellulose	Polypropylene
spunbond
Inner
Material	Polypropylene	Polyethylene/
Polyester	Polyester cellulose
Filter Media	1. Polypropylene
spunbond

Polypropylene
meltblown | 1. Polypropy-
lene
meltblown | 1. Polypropylene spunbond
Polypropylene meltblown | |
| Nose Clamp | | N/A | N/A | |
| Ear Loops/
Tie Tapes | Ear loops: Polyester, polyurethane
Side tapes:
Polyester spunbond (ear loops mask only)

Tie tapes:
Polypropylene spunbond or polyester spunbond | Ear loops:
Polyester/lycra knitted

Tie tapes:
Polyester spunlace | Ear loops:
Polyester/lycra knitted

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.
--------------------	-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

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
Characteristics	The Surgical Face Masks (Ear loops and Tie-on) are substantially
equivalent to the current legally marketed predicated devices
cleared in K110455 and K111402. The product conforms to the
recognized standards ASTM F2100-11, ASTM F1862, ASTM
F2101, and ISO 10993 in addition to the requirements stated in the
Guidance for Industry and FDA Staff: Surgical Masks-Premarket
Notifications [510(k)] Submissions, issued March 5, 2004.
Performance &
Biocompatibility	The Surgical Face Masks (Ear loops and Tie-on) have been tested
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)
Surgical Face Masks (Ear loops and
Tie-on) | | | (K110455)
KC100
Mask | (K111402)
KC 200
Face Mask
KC 300
Face Mask | |
|----------------------------------|-------------------------------------------------------------------------------|------------------------------|------------------------------|------------------------------------------------------------------------------------|--------------------------------------------------------------------------|------------------------------|
| TEST | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 |
| ASTM
F2100-11 | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 |
| 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 |
| ASTM
F2299 | Pass at
99.6% | Pass at
99.6% | Pass at
99.7% | Pass at
98.4% | Pass at
98.4% | Pass at
98.4% |
| ASTM
F2101 | Pass at

98% | Pass at
98% | Pass at
99% | Pass at
99.7% | Pass at
99.7% | Pass at
99.7% |
| MIL-
M36945C | Pass at 2.0
mmH2O/cm
2 | Pass at 1.6
mmH2O/cm
2 | Pass at 2.5
mmH2O/cm
2 | Pass at 3.0
mmH2O/cm
2 | Pass at 4.5
mmH2O/cm
2 | Pass at 3.2
mmH2O/cm
2 |
| 16 CFR
1610 | Class 1 | Class 1 | Class 1 | Class 1 | Class 1 | Class 1 |
| Cytotoxicity
ISO
10993-5 | Under the conditions of the study, the
subject device was non-cytotoxic. | | | Under the
conditions
of the study,
the device
was non-
cytotoxic. | Under the conditions of
the study, the device was
non-cytotoxic. | |
| Irritation
ISO
10993-10 | Under the conditions of the study, the
subject device was non-irritating. | | | Under the
conditions
of the study,
the device
was non-
irritating. | Under the conditions of
the study, the device was
non-irritating. | |
| Sensitization
ISO
10993-10 | Under the conditions of the study, the
subject device was non-sensitizing. | | | Under the
conditions
of the study,
the device
was non-
sensitizing. | Under the conditions of
the study, the device was
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.