N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12

K160271 · San-M Package Co., Ltd. · MSH · Jul 15, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K160271
• Device Name: N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12
• Applicant: San-M Package Co., Ltd.
• Product Code: MSH · General, Plastic Surgery
• Decision Date: Jul 15, 2016
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The N95 Particulate Respirator and Surgical Mask, Models TN01-12 are single-use, disposable devices, provided non-sterile, and are intended to be worn by operating room personnel or other healthcare workers to protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

Device Story

N95 Particulate Respirator and Surgical Mask (Models TN01-11, TN01-12) are single-use, non-sterile, disposable respiratory protective devices. Constructed of four layers: polypropylene spunbond outer, two layers of polypropylene meltblown filter media, and polypropylene/polyethylene inner layer. Features include ultrasonically welded polyurethane elastic headbands (latex-free) and polyethylene-coated steel wire nose clamp for facial contouring. Flat-folded design becomes pouch-shaped when worn. Used in operating rooms, dental, and isolation settings by healthcare personnel to provide barrier protection against microorganisms, body fluids, and particulates. NIOSH-certified (TC 84A-3348).

Clinical Evidence

Bench testing only. Performance validated via NIOSH certification (TC 84A-3348) for particulate filtration, bacterial filtration efficiency, and differential pressure. Fluid resistance tested per ASTM F1862 (pass at 160 mmHg). Flammability tested per 16 CFR 1610 (Class 1). Biocompatibility testing per ISO 10993-1, 10993-5, and 10993-10 confirmed device is non-cytotoxic, non-sensitizing, and non-irritating.

Technological Characteristics

Four-layer nonwoven construction: polypropylene spunbond outer, two polypropylene meltblown filter layers, polypropylene/polyethylene inner. Polyethylene-coated steel wire nose clamp. Polyurethane elastic headband. Flat-folded, pouch-style form factor. NIOSH-certified (TC 84A-3348). Tested to ASTM F1862 (fluid resistance), ASTM F2101 (BFE), and ISO 10993 (biocompatibility). Non-sterile.

Indications for Use

Indicated for operating room personnel or other healthcare workers to protect patient and personnel from transfer of microorganisms, body fluids, and particulate material.

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

• Prestige Ameritech Pro Gear N95 Particulate Filter Respirator and Surgical Mask (K102092)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a single abstract figure.

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

July 15, 2016

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

Re: K160271

Trade/Device Name: N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: MSH Dated: June 10, 2016 Received: June 15, 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 device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K160271

#### Device Name

N95 Particulate Respirator and Surgical Masks, Models TN01-11 and TN01-12

Indications for Use (Describe)

The N95 Particulate Respirator and Surgical Mask, Models TN01-12 are single-use, disposable devices, provided non-sterile, and are intended to be worn by operating room personnel or other healthcare workers to protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

| 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)

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## 510(k) Summary for N95 Particulate Respirator and Surgical Mask

| 510(k) Owner/<br>Applicant | SAN-M PACKAGE CO., LTD.<br>1086-1 Ojiro<br>Shimada-City Sizuoka, JAPAN 428-8652 |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| US Correspondent | Takahiro Haruyama<br>Globizz Corporation<br>[phone]<br>[e-mail] |
| Date Prepared | July 15, 2016 |
| Trade Name | N95 Particulate Respirator and Surgical Mask,<br>Models TN01-11 and TN01-12 |
| Common Name | N95 Surgical Respirator |
| Classification Name | Surgical apparel |
| Review Panel | General Hospital |
| Product Code | MSH |
| Device Classification | Class II per 21 CFR §878.4040 |
| Predicate Device | The N95 Particulate Respirator and Surgical Mask, Models TN01-11<br>and TN01-12 are substantially equivalent to the Prestige Ameritech<br>Pro Gear N95 Particulate Filter Respirator and Surgical Mask cleared<br>in K102092. A comparison between the proposed and predicate<br>device is shown in Table 5-A below. |

Table 5-A. Comparison of characteristics.

| Feature | N95 Particulate Respirator and<br>Surgical Mask (Proposed Device) | Pro Gear N95 Particulate Filter<br>Respirator and Surgical mask<br>(Predicate Device) |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) # | K160271 | K102092 |
| Manufacturer | San-M Package Co., Ltd. | Prestige Ameritech |
| Common Name | N95 Surgical Respirator | N95 Surgical Respirator |
| Classification # | Class II | Class II |
| Product Code | MSH | MSH |
| Intended Use | The N95 Particulate Respirator and<br>Surgical Mask, Models TN01-11 | The Prestige Ameritech N95<br>Respirator and Surgical Mask |
| | and TN01-12 are single-use, non-<br>sterile, disposable devices intended<br>to be worn by operating room<br>personnel or other healthcare<br>workers to protect both the patient<br>and operating room personnel from<br>the transfer of microorganisms,<br>body fluids, and particulate<br>material. | RP88020 is a single use non-sterile<br>disposable device intended to be<br>worn in the operating room as well<br>as dental, isolation and other<br>medical procedures to protect both<br>the patient and healthcare personnel<br>from transfer of microorganisms,<br>body fluids, and particulate<br>material. |
| Materials | | |
| Outer Material | Polypropylene spunbond | Polypropylene spunbond |
| Inner Material | Polypropylene and polyethylene | Biocomponent nonwoven |
| Filter Media | Two layers of polypropylene<br>meltblown | Two layers of polypropylene<br>meltblown |
| Nose Clamp | Polyethylene coated steel wire | Malleable aluminum |
| Headband | Polyurethane, not made with natural<br>rubber latex | Elastic not made with natural<br>rubber latex |
| Design Features | Manufactured by ultrasonic<br>bonding, composed of four layers<br>of materials, trapezoid-shaped when<br>flat-folded, pouched-shaped when<br>worn, single-use, disposable<br>respirator, and nose clamp to<br>contour to the wearer. | Manufactured by ultrasonic<br>bonding, composed of four layers<br>of materials pouched and pleated to<br>form the mask. Held on wearer with<br>an elastic headband and contains a<br>malleable aluminum nosepiece<br>strip. |
| Specifications<br>and Dimensions | • Colors: orange or white<br>TN01-12 (Small):<br>• Length: 205 ± 5 mm<br>• Width: 75 ± 5 mm<br>• Band length: 205 ± 5 mm<br>TN01-11 (Medium):<br>• Length: 240 ± 5 mm<br>• Width: 75 ± 5 mm<br>• Band length: 240 ± 5 mm | N/A |
| Mask Style | Flat-folded, Pouch | Pouch |
| Sterility | Non-sterile | Non-sterile |
| Performance | | |
| Testing | | |
| Fluid Resistance | Pass at 160 mmHg (ASTM F1862) | Pass at 160 mmHg (ASTM F1862) |
| Particulate | NIOSH Certification #<br>TC 84A-3348 | NIOSH Certification #<br>TC 84A-5216 |
| Filtration<br>Efficiency(PFE) | (includes TN01-11 & TN01-12) | |
| Bacterial<br>Filtration<br>Efficiency(BFE) | NIOSH Certification #<br>TC 84A-3348<br>(includes TN01-11 & TN01-12) | NIOSH Certification #<br>TC 84A-5216 |
| Differential<br>Pressure (△ P) | NIOSH Certification #<br>TC 84A-3348<br>(includes TN01-11 & TN01-12) | NIOSH Certification #<br>TC 84A-5216 |
| Flammability | Class 1 (16 CFR 1610) | Class 1 (16 CFR 1610) |
| Biocompatibility | Under the conditions of the study,<br>the device was non-cytotoxic, non-<br>sensitizing, and non-irritating.<br>(ISO 10993) | (ISO 10993) |

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Device Description The N95 Particulate Respirator and Surgical Mask, Models #TN01-11 and #TN01-12 are NIOSH certified (TC 84A-3348), pouchedshaped respirators when worn. The flat-folded masks are composed of four layers of materials consisting of polypropylene and polyethylene (inner layer), polypropylene meltblown (two filter layers), and polypropylene spunbond (outer layer). The masks contain a conformable nose clamp enclosed in a binding tape welding the top edge to conform to the contours of the face. In addition, the masks contain an ultrasonically welded, polyurethane elastic headband not made with natural rubber latex, to secure the masks in place on the wearer. The masks are offered in orange or white.

The N95 Particulate Respirator and Surgical Mask, Models TN01-11 Intended Use and TN01-12 are single-use, disposable devices, provided non-sterile and are intended to be worn by operating room personnel or other healthcare workers to protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

- Model Numbers # TN01-11: N95 Particulate Respirator and Surgical Mask (Medium Size)
- # TN01-12: N95 Particulate Respirator and Surgical Mask (Small Size)

Technological The N95 Particulate Respirator and Surgical Mask is substantially equivalent to the current legally marketed. NIOSH-certified Pro Gear Characteristics N95 Particulate Filter Respirator and Surgical Mask (K102092). The product was tested according to the recognized standards ASTM F1862, ASTM F2101, and ISO 10993 in addition to the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks

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

The N95 Particulate Respirator and Surgical Mask, Models TN01-11 Performance Testing and TN01-12 have been tested according to the Guidance for Industry and FDA Staff: Surgical Masks-Premarket Notifications [510(k)] Submissions, issued March 5, 2004. Where applicable, NIOSH certification number is provided in lieu of performance testing data as noted in the guidance document:

| Criteria | N95 Particulate Respirator and Surgical<br>Mask Standard Test Results |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Fluid Resistance | Models TN01-11 and TN01-12 meet the<br>requirements of ASTM F1862. |
| Particulate<br>Filtration<br>Efficiency | NIOSH Certification Number: TC 84A-3348<br>(Models TN01-11 and TN01-12) |
| Bacterial<br>Filtration<br>Efficiency | NIOSH Certification Number: TC 84A-3348<br>(Models TN01-11 and TN01-12) |
| Differential<br>Pressure | NIOSH Certification Number: TC 84A-3348<br>(Models TN01-11 and TN01-12) |
| Flammability | Meets 16 CFR 1610 Standard for class 1<br>flammability. |
| Biocompatibility | Referenced ISO 10993-1 to determine<br>standard tests required for surface devices<br>with limited contact (≤ 24 hours), contacting<br>intact skin. |
| Cytotoxicity | Under the conditions of the study, the<br>subject device was non-cytotoxic.<br>(ISO 10993-5) |
| Irritation | Under the conditions of the study, the<br>subject device was non-irritating.<br>(ISO 10993-10) |
| Sensitization | Under the conditions of the study, the<br>subject device was non-sensitizing.<br>(ISO 10993-10) |

Table 5-B. Conformance to performance testing requirements.

### 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

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has the same or similar performance characteristics and are both fluid resistant with the flammability of Class 1. Both products are NIOSH certified and the N95 Particulate Respirator and Surgical Mask, Models TN01-11 and TN01-12 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 device K102092.