MEDICAL SURGICAL MASK (HH1001), RESPIRATORY MASK (HH1002)

K093179 · H&H Research Company · FXX · Jul 14, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K093179
• Device Name: MEDICAL SURGICAL MASK (HH1001), RESPIRATORY MASK (HH1002)
• Applicant: H&H Research Company
• Product Code: FXX · General, Plastic Surgery
• Decision Date: Jul 14, 2010
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4040
• Device Class: Class 2

Intended Use

This product is indicated for infection control practices in the health care industry. When worn properly, The New Medical Mask is intended to protect both patient and wearer from the transfer of microorganisms, body fluids and particulate material.

Device Story

The New Medical Mask is a single-use, flat-style surgical mask designed for infection control in healthcare settings. It features a polypropylene filter and covering, with non-latex elastic ear bands for attachment and adhesive tape for nose positioning. The device acts as a physical barrier to reduce the transfer of microorganisms, body fluids, and particulate material between the wearer and the patient. It is intended for use by healthcare personnel during procedures. The mask is evaluated for performance against ASTM F 2100-07 standards, including bacterial filtration efficiency, differential pressure, sub-micron particulate filtration, and synthetic blood penetration resistance.

Clinical Evidence

Bench testing only. Performance evaluated against ASTM F 2100-07 standards. Results: Bacterial Filtration Efficiency >99.9%; Differential Pressure 2.7 mm H2O/cm²; Sub-micron Particulate Filtration (0.1 micron) 99.9%; Synthetic blood penetration resistance passed at 160 mmHg; Flammability Class 1.

Technological Characteristics

Materials: Polypropylene filter and covering. Design: Flat style, non-latex elastic ear bands, adhesive tape nose-piece. Dimensions: 18 cm x 10 cm. Performance standards: ASTM F 2100-07, ASTM F 2101, ASTM F 2299, ASTM F 1862, 16 CFR Part 1610. Single-use, non-sterile.

Indications for Use

Indicated for infection control in healthcare settings; intended to protect both patient and wearer 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

• TIDI Facemask (K092580)
• Spunguard Mask (K823078)
• 3M Particulate Respirator and Surgical Mask Model 1870 (K063023)

Submission Summary (Full Text)

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## JUL 1 4 2010

#### 510(k) SUMMAR Y

510(k) Number:

K093179

Submitted by Owner:

Jong T. Huang, MD, FACP President H & H Research Company 1245 Wilshire Blvd., No. 501 Los Angeles, CA 90017 Fax: [phone] Tel: [phone] Email: [e-mail]

June 9, 2010 Date of Preparation:

Name of Device:

The New Medical Mask

Classification Name and Product Code: Medical Mask; Surgical Apparel (21CFR878.4040) Product Code: FXX

## SUMMARY STATEMENT:

Predicate Products: TIDI™ Facemask, Tidi Products, LLC: K092580 Spunguard Mask, Kimberly-Clark: K823078 3M Particulate Respirator and Surgical Mask Model 1870: K063023

Comparison of Intended Use:

This product is indicated for infection control practices in the health care industry.

When worn properly. The New Medical Mask is intended to protect both patient and wearer from the transfer of microorganisms. body fluids and particulate material.

#### Predicates:

TIDI Facemask - The TIDI Facemasks by Tidi Products, LLC, are surgical masks intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating personnel from transfer of microorganisms, body. fluids and particulate material.

Spunguard - The Spunguard mask is intended to protect both the patient and the wearer from transfer of microorganisms, body fluids, and particulate material.

3M Particulate Respirator and Surgical Mask Model 1870 - As a respirator, it is intended to help reduce wearer exposure to certain airborne particles including those generated by

510(k) K093179 The New Medical Mask

H & H Research Company

13

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electrocautery, laser surgery, and other powered medical instruments. As a surgical mask, it is designed to be fluid resistant to splash and spatter of blood and other infectious materials.

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510(k) K093179 The New Medical Mask

H & H Research Company

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| | | Comparison of Design Characteristics: Predicate = TIDI Facemask | | | |
|--|--|-----------------------------------------------------------------|--|--|--|
|--|--|-----------------------------------------------------------------|--|--|--|

| Feature | The New Medical Mask | Predicate (K092580) |
|-----------------|-----------------------------|-----------------------------|
| Style | flat | flat pleated |
| Attachment | non-latex elastic ear bands | non-latex elastic ear loops |
| Nose | adhesive tape | malleable aluminum |
| Filter Material | polypropylene | polypropylene |
| Covering | polypropylene | polypropylene |
| Length | 7.1 inches (18 cm) | 7.0 inches |
| Width | 3.9 inches (10 cm) | 3.5 inches |
| Sterile | No | No |
| Single Use | Yes | Yes |

Comparison of Performance Characteristics: Predicate = TIDI Facemask

Both products meet the requirements of ASTM F 2100 - 07, Standard Specification for Performance of Materials Used in Medical Face Mask, as demonstrated below:

| Performance Characteristics | The New Medical<br>Mask | Predicate<br>K092580 |
|--------------------------------------------------------------------------------------------------------------|-------------------------------|-------------------------------|
| Bacterial Filtration Efficiency<br>Performance (%) (ASTM F 2101) | >99.9%<br>High Barrier | >99.9%<br>High Barrier |
| Differential Pressure (Delta-P) (mm<br>H2O/cm²) (MIL-M-36954C) | 2.7 mm H2O/cm²<br>Low Barrier | 3.4 mm H2O/cm²<br>Low Barrier |
| Sub-micron Particulate Filtration<br>Efficiency at 0.1 micron Performance<br>(%) (ASTM F 2299) | 99.9%<br>High Barrier | 99.6%<br>High Barrier |
| Resistance to penetration by synthetic<br>blood, Minimum pressure in mmHg for<br>pass results. (ASTM F 1862) | Pass at 160 mmHg | Pass at<br>80<br>mmHg |
| Flammability Class<br>(16 CFR Part 1610) | Class 1 | Class 1 |

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## Conclusion:

The New Medical Mask has the same intended use as the predicate devices. It has the same design and performance characteristics as the TIDI Facemask and presumably of any other mask that meets the Standard Specification, ASTM F 2100 and which followed the FDA Guidance - Surgical Mask Premarket Notification [510(k)] Submission; Guidance for Industry and FDA (3/5/05, 9/14/07) during development.

510(k) K093179 The New Medical Mask

H & H Research Company

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Image /page/4/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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes, creating a sense of unity and connection.

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

Mr. Jong Huang President H & H Research Company 1245 Wilshire Boulevard #501 Los Angeles, California 90017

JUL 1 4 2010

Re: K093179

Trade/Device Name: The New Medical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: FXX Dated: June 9, 2010 Received: June 17, 2010

Dear Mr. Huang:

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.

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## Page 2- Mr. Huang

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-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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, 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): K093179

Device Name:

The New Medical Mask

Indications For Use:

This product is indicated for infection control practices in the health care industry.

When worn properly, The New Medical Mask is intended to protect both patient and wearer from the transfer of microorganisms, body fluids and particulate material.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices 11

510(k) K093179 The New Medical Mask

H & H Research Company

KD93199 : 510(k) Number: J