(164 days)
Not Found
No
The device is a physical mask and the description focuses on its materials, construction, and performance characteristics related to filtration and fluid resistance, with no mention of AI/ML.
No.
The device is a mask intended to protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material, which is a protective function, not a therapeutic one.
No
A diagnostic device is used to detect, diagnose, or monitor a medical condition. This device, an N95 Particulate Respirator and Surgical Mask, is designed to protect users from the transfer of microorganisms, body fluids, and particulate material, which is a protective function, not a diagnostic one.
No
The device description clearly outlines a physical product made of multiple layers of materials (polypropylene, polyethylene) with physical components like a nose clamp and headband, and the performance studies focus on physical properties like fluid resistance, filtration efficiency, and flammability. There is no mention of software as part of the device's function or description.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "Particulate Respirator and Surgical Mask" intended to protect healthcare workers and patients from the transfer of microorganisms, body fluids, and particulate material. This is a barrier device for personal protection and infection control.
- Device Description: The description details the physical construction and materials of a mask, not a device used to examine specimens from the human body.
- Lack of IVD Characteristics: The document does not mention any of the key characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
- Measuring biomarkers or analytes
IVDs are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a physical barrier.
N/A
Intended Use / Indications for 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.
Product codes
MSH
Device Description
The N95 Particulate Respirator and Surgical Mask, Models #TN01-11 and #TN01-12 are NIOSH certified (TC 84A-3348), pouched-shaped 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.
- Model Numbers # TN01-11: N95 Particulate Respirator and Surgical Mask (Medium Size)
-
TN01-12: N95 Particulate Respirator and Surgical Mask (Small Size)
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
Operating room personnel or other healthcare workers
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 N95 Particulate Respirator and Surgical Mask, Models TN01-11 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:
- Fluid Resistance: Models TN01-11 and TN01-12 meet the requirements of ASTM F1862.
- Particulate Filtration Efficiency: NIOSH Certification Number: TC 84A-3348 (Models TN01-11 and TN01-12)
- Bacterial Filtration Efficiency: NIOSH Certification Number: TC 84A-3348 (Models TN01-11 and TN01-12)
- Differential Pressure: NIOSH Certification Number: TC 84A-3348 (Models TN01-11 and TN01-12)
- Flammability: Meets 16 CFR 1610 Standard for class 1 flammability.
- Biocompatibility: Referenced ISO 10993-1 to determine standard tests required for surface devices with limited contact (≤ 24 hours), contacting intact skin.
- Cytotoxicity: Under the conditions of the study, the subject device was non-cytotoxic. (ISO 10993-5)
- Irritation: Under the conditions of the study, the subject device was non-irritating. (ISO 10993-10)
- Sensitization: Under the conditions of the study, the subject device was non-sensitizing. (ISO 10993-10)
The conclusions drawn from the non-clinical tests demonstrate that the device is substantially equivalent to the predicate device K102092.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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 (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,
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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3
510(k) Summary for N95 Particulate Respirator and Surgical Mask
| 510(k) Owner/
Applicant | SAN-M PACKAGE CO., LTD.
1086-1 Ojiro
Shimada-City Sizuoka, JAPAN 428-8652 |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| US Correspondent | Takahiro Haruyama
Globizz Corporation
(310) 538-3860
register@globizz.net |
| Date Prepared | July 15, 2016 |
| Trade Name | N95 Particulate Respirator and Surgical Mask,
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
and TN01-12 are substantially equivalent to the Prestige Ameritech
Pro Gear N95 Particulate Filter Respirator and Surgical Mask cleared
in K102092. A comparison between the proposed and predicate
device is shown in Table 5-A below. |
Table 5-A. Comparison of characteristics.
| Feature | N95 Particulate Respirator and
Surgical Mask (Proposed Device) | Pro Gear N95 Particulate Filter
Respirator and Surgical mask
(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
Surgical Mask, Models TN01-11 | The Prestige Ameritech N95
Respirator and Surgical Mask |
| | and TN01-12 are single-use, non-
sterile, disposable devices 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. | RP88020 is a single use non-sterile
disposable device intended to be
worn in the operating room as well
as dental, isolation and other
medical procedures to protect both
the patient and healthcare personnel
from transfer of microorganisms,
body fluids, and particulate
material. |
| Materials | | |
| Outer Material | Polypropylene spunbond | Polypropylene spunbond |
| Inner Material | Polypropylene and polyethylene | Biocomponent nonwoven |
| Filter Media | Two layers of polypropylene
meltblown | Two layers of polypropylene
meltblown |
| Nose Clamp | Polyethylene coated steel wire | Malleable aluminum |
| Headband | Polyurethane, not made with natural
rubber latex | Elastic not made with natural
rubber latex |
| Design Features | Manufactured by ultrasonic
bonding, composed of four layers
of materials, trapezoid-shaped when
flat-folded, pouched-shaped when
worn, single-use, disposable
respirator, and nose clamp to
contour to the wearer. | Manufactured by ultrasonic
bonding, composed of four layers
of materials pouched and pleated to
form the mask. Held on wearer with
an elastic headband and contains a
malleable aluminum nosepiece
strip. |
| Specifications
and Dimensions | • Colors: orange or white
TN01-12 (Small):
• Length: 205 ± 5 mm
• Width: 75 ± 5 mm
• Band length: 205 ± 5 mm
TN01-11 (Medium):
• Length: 240 ± 5 mm
• Width: 75 ± 5 mm
• 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 #
TC 84A-3348 | NIOSH Certification #
TC 84A-5216 |
| Filtration
Efficiency(PFE) | (includes TN01-11 & TN01-12) | |
| Bacterial
Filtration
Efficiency(BFE) | NIOSH Certification #
TC 84A-3348
(includes TN01-11 & TN01-12) | NIOSH Certification #
TC 84A-5216 |
| Differential
Pressure (△ P) | NIOSH Certification #
TC 84A-3348
(includes TN01-11 & TN01-12) | NIOSH Certification #
TC 84A-5216 |
| Flammability | Class 1 (16 CFR 1610) | Class 1 (16 CFR 1610) |
| Biocompatibility | Under the conditions of the study,
the device was non-cytotoxic, non-
sensitizing, and non-irritating.
(ISO 10993) | (ISO 10993) |
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5
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
6
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
Mask Standard Test Results |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Fluid Resistance | Models TN01-11 and TN01-12 meet the
requirements of ASTM F1862. |
| Particulate
Filtration
Efficiency | NIOSH Certification Number: TC 84A-3348
(Models TN01-11 and TN01-12) |
| Bacterial
Filtration
Efficiency | NIOSH Certification Number: TC 84A-3348
(Models TN01-11 and TN01-12) |
| Differential
Pressure | NIOSH Certification Number: TC 84A-3348
(Models TN01-11 and TN01-12) |
| Flammability | Meets 16 CFR 1610 Standard for class 1
flammability. |
| Biocompatibility | Referenced ISO 10993-1 to determine
standard tests required for surface devices
with limited contact (≤ 24 hours), contacting
intact skin. |
| Cytotoxicity | Under the conditions of the study, the
subject device was non-cytotoxic.
(ISO 10993-5) |
| Irritation | Under the conditions of the study, the
subject device was non-irritating.
(ISO 10993-10) |
| Sensitization | Under the conditions of the study, the
subject device was non-sensitizing.
(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
7
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.