Master-Frank N95 Particulate Respirator

K172963 · Master & Frank Enterprise Co., Ltd. · MSH · Apr 4, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K172963
• Device Name: Master-Frank N95 Particulate Respirator
• Applicant: Master & Frank Enterprise Co., Ltd.
• Product Code: MSH · General, Plastic Surgery
• Decision Date: Apr 4, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

The N95 Particulate Respirator (MF01) is single-use, disposable device, 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

Master-Frank N95 Particulate Respirator (MF-01) is a single-use, non-sterile, flat-folded, pouch-style respirator. Device consists of four layers (inner, two filter layers, outer) of polypropylene non-woven fabric, ultrasonically welded. Includes nose-piece (polyethylene/steel wire) and synthetic rubber head straps. Worn by healthcare personnel to provide barrier protection against microorganisms, body fluids, and particulates. NIOSH-certified (TC-84A-7697).

Clinical Evidence

Bench testing only. Biocompatibility testing per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation, sensitization) confirmed non-cytotoxic, non-irritating, and non-sensitizing. Physical performance testing included fluid resistance (ASTM F1862, pass at 160 mmHg), flammability (16 CFR 1610, Class 1), and NIOSH certification (TC-84A-7697) for particulate filtration efficiency, bacterial filtration efficiency, and differential pressure.

Technological Characteristics

Four-layer polypropylene non-woven fabric construction; ultrasonically welded; polyethylene/steel wire nose-piece; synthetic rubber straps. Flat-folded, pouch-style form factor. Non-sterile. NIOSH-certified. Complies with ASTM F1862 (fluid resistance) and 16 CFR 1610 (flammability).

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

• N95 Particulate Respirator and Surgical Mask (K160271)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, and the FDA logo is on the right. The FDA logo includes the agency's name, "U.S. Food & Drug Administration," in blue text.

April 4, 2018

Master & Frank Enterprise Co., Ltd % Field Fu Official Correspondent Shenzhen Joyantech Consulting Co., Ltd Room 1122, No.55 Shizhou Middle Road, Nanshan District Shenzhen, gd755 Cn

Re: K172963

Trade/Device Name: Master-Frank N95 Particulate Respirator Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: MSH Dated: March 5, 2018 Received: March 13, 2018

Dear Field Fu:

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

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801); medical device reporting of medical device-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.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Geeta K. Pamidimukkala -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

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## Indications for Use

510(k) Number (if known) K172963

Device Name

Master-Frank N95 Particulate Respirator

#### Indications for Use (Describe)

The N95 Particulate Respirator (MF01) is single-use, disposable device, provided non-sterile, and are intended to be worn by operating room personnel or other healthcare workers to protect 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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# K172963

# 510(k) Summary

# 1. Submission Sponsor

| Applicant Name | Master & Frank Enterprise Co., Ltd |
|----------------|--------------------------------------------------------------------------------------|
| Address | Banhu Industrial District, Huang Jiang,Dong Guan<br>City, Guang Dong Province, CHINA |
| Phone No. | [phone] |
| Fax No. | [phone] |
| Contact Person | Ms. Shuge Zhao |
| Email | [e-mail] |
| Date Prepared | 04/03/2018 |

# 2. Submission correspondent

| Name | Shenzhen Joyantech Consulting Co., Ltd |
|----------------|----------------------------------------------------------------------------------------------------|
| Address | Room 1122, No.55 Shizhou Middle Road, Nanshan<br>District,<br>Shenzhen,<br>Guangdong,<br>P.R.China |
| Image | Image: logo |
| Post Code | 518000 |
| Phone No. | 86-755-86069197 |
| Contact Person | Mr. Field Fu; Ms. Jessie You |
| Email | [e-mail]; [e-mail] |

# 3. Device Identification

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| Trade / Proprietary Name | Master-Frank N95 Particulate respirator |
|---------------------------|-----------------------------------------|
| Common / Usual Name | N95 Surgical Respirator |
| Classification Name | Surgical apparel |
| Classification Regulation | 21 CFR 878.4040 |
| Product Code | MSH |
| Classification Panel | General Hospital |

### 4. Legally Marketed Predicate Devices

| | Trade Name N95 Particulate Respirator and Surgical Mask | |
|-------------------------|-----------------------------------------------------------|--|
| 510(k) Number K160271 | | |
| Product Code MSH | | |
| Manufacturer | San-M Package Co., Ltd. | |

## 5. Device Description

-

The N95 particulate respirator (Model MF-01) is NIOSH certified (TC-84A-7697), pouched-shaped respirators when worn. The flat-folded respirator is composed of four layers-inner layer, filter (2 layers) and outer layer. The four layers are combined via ultrasonically welded. The respirator also contains a nose-piece enclosed in a binding tape welding the top edge to conform to the contours of the face. The respirator contains straps to secure the respirator in place on the wearer. The respirator is offered in white. The respirator is provided non-sterile and for single use only.

## 6. Indications for Use Statement

The N95 Particulate Respirator (MF01) is single-use, disposable device, 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.

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| Item | Proposed Device: | Predicate Device: | Comments |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Master-Frank N95<br>Particulate<br>respirator | N95 Particulate<br>Respirator and<br>Surgical Mask | |
| 510 (k)<br>number | K172963 | K160271 | None |
| Manufacturer | Master & Frank<br>Enterprise Co., Ltd | SAN-M PACKAGE<br>CO., LTD. | None |
| Common<br>name | N95 Surgical<br>Respirator | N95 Surgical<br>Respirator | Same |
| Classification<br>name | Surgical apparel | Surgical apparel | Same |
| Classification | II | II | Same |
| Product code | MSH | MSH | Same |
| Indications<br>for use | OTC:<br>The N95 Particulate<br>Respirator (MF01) is<br>single-use,<br>disposable device,<br>provided non-sterile,<br>and are intended to<br>be worn by operating<br>room personnel or<br>other healthcare<br>workers to protect | OTC:<br>The N95 Particulate<br>Respirator and Surgical<br>Mask, Models TN01-11<br>and TN01-12 are<br>single-use, disposable<br>devices, provided<br>non-sterile, and are<br>intended to be worn by<br>operating room<br>personnel or other | Same |
| | | | |
| | both the patient and | healthcare workers to | |
| | operating room | protect both the patient | |
| | personnel from the | and operating room | |
| | transfer of | personnel from the | |
| | microorganisms, body | transfer of | |
| | fluids, and particulate | microorganisms, body | |
| | material. | fluids, and particulate | |
| | | material. | |
| Materials | | | |
| Outer material | Polypropylene | Polypropylene | Same |
| | spunbond non-woven | spunbond | |
| | fabric | | |
| Inner material | Polypropylene | Polypropylene and | All of the |
| | spunbond non-woven | polyethylene | materials |
| | fabric | | are common |
| | | | fabric |
| | | | material for |
| | | | making a |
| | | | respirator. |
| | | | Safety of the |
| | | | materials |
| | | | has been |
| | | | proved by |
| | | | biocompatibi |
| | | | lity testing. |
| Filter media | Two layers of | Two layers of | Same |
| | melt-blown | polypropylene | |
| | polypropylene fabric | meltblown | |
| Nose-piece<br>(Nose clamp) | Polyethylene + steel<br>wire | Polyethylene coated<br>steel wire | Same |
| Straps<br>(Headband) | Synthetic rubber | Polyurethane, not<br>made with natural<br>rubber latex | The allergy<br>reaction to<br>rubber has<br>been<br>mentioned<br>as a warning<br>in the<br>labeling, and<br>safety of the<br>materials<br>has been<br>proved by<br>biocompatibility testing. |
| Design<br>features | Manufactured by<br>ultrasonic bonding,<br>composed of four<br>layers of materials,<br>trapezoid-shaped<br>when flat-folded,<br>pouched-shaped<br>when worn,<br>single-use,<br>disposable respirator,<br>and nose-piece to<br>contour to the wearer. | Manufactured by<br>ultrasonic bonding,<br>composed of four<br>layers<br>of materials,<br>trapezoid-shaped when<br>flat-folded,<br>pouched-shaped when<br>worn, single-use,<br>disposable respirator,<br>and nose clamp to<br>contour to the wearer. | Same |
| Specification | MF-01 | TN01-12 (Small):<br>A | Similar |
| s and | The upper side length | Length: 205 ± 5 mm | (Size of |
| dimensions | of trapezoid: 98mm | Width: 75 ± 5 mm | MF-01 is |
| | The bottom side | Band length: 205 ± 5 | similar with |
| | length of trapezoid: | mm | Medium) |
| | 240mm | TN01-11<br>> | |
| | Width: 90mm | (Medium): | |
| | Straps: | Length: 240 ± 5 mm | |
| | Length: 580mm | Width: 75 ± 5 mm | |
| | Width: 5mm | Band length: 240 ± 5 | |
| | | mm | |
| Mask style | Flat-folded, Pouch | Flat-folded, Pouch | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Biocompatibi | The biocompatibility | Referenced ISO | Same |
| lity | testing items were | 10993-1 to determine | |
| | determined in | standard tests required | |
| | accordance with the | for surface devices | |
| | FDA guidance | with limited contact ([] | |
| | "Use of International | 24 hours), contacting | |
| | Standard ISO | intact skin: | |
| | 10993-1" and ISO | Cytotoxicity (ISO<br>A | |
| | 10993-1, the product | 10993-5): the | |
| | is surface device with | device was | |
| | limited contact (within | non-cytotoxic; | |
| | 24 hours) and | Irritation (ISO<br>A | |
| | contacting intact skin: | 10993-10): the | |
| | Cytotoxicity (ISO<br>A | device was | |
| | 10993-5): the | non-irritating; | |
| | device was | Sensitization (ISO | |
| | non-cytotoxic; | 10993-10): the | |
| | Irritation (ISO | device was | |
| | 10993-10): the | non-sensitizing. | |
| | device was | | |
| | non-irritating; | | |
| | Sensitization | | |
| | (ISO 10993-10): | | |
| | the device was | | |
| | non-sensitizing. | | |
| Performance | | | |
| testing | | | |
| Fluid | Pass at 160 mmHg | Pass at 160 mmHg | Same |
| resistance | (ASTM F1862) | (ASTM F1862) | Same |
| | | | |
| | | | |
| Flammability | Class 1 (16 CFR | Class 1 (16 CFR | Same |
| | 1610) | 1610) | Same |
| | | | |
| Particulate | NIOSH Certification # | NIOSH Certification | Same |
| filtration | TC-84A-7697 | #TC 84A-3348 | Same |
| efficiency | | (includes TN01-11 & | Same |
| (PFE) | | TN01-12) | Same |
| Bacterial<br>filtration<br>efficiency<br>(BFE) | NIOSH Certification # | NIOSH Certification | Same |
| | TC-84A-7697 | #TC 84A-3348<br>(includes TN01-11 &<br>TN01-12) | |
| Differential<br>Pressure ( $\triangle$ P) | NIOSH Certification # |…