MOLDEX-METRIC HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1712

K102173 · Moldex/Metric, Inc. · MSH · Sep 13, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K102173
• Device Name: MOLDEX-METRIC HEALTH CARE N95 PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1712
• Applicant: Moldex/Metric, Inc.
• Product Code: MSH · General, Plastic Surgery
• Decision Date: Sep 13, 2010
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.4040
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The model 1712 Moldex-Metric Type N95 Healthcare Particulate Respirator and Surgical Mask meets CDC Guidelines for TB Exposure Control within healthcare facilities. This device is also intended to be worn by healthcare personnel during surgical procedures to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material.

Device Story

The Model 1712 is a flat-fold N95 particulate respirator and surgical mask; used in healthcare settings by personnel during surgical procedures or TB exposure control. It functions as a physical barrier; constructed with an extruded plastic mesh outer cover, nonwoven spunbond inner/outer layers, and a polypropylene melt-blown filter media. It features a non-latex rubber head strap and closed-cell polyethylene foam nosepiece. The device is NIOSH-certified (TC-84A-5227) to provide ≥95% filtration efficiency against 0.055–0.095 micron particles. It is resistant to synthetic blood penetration per ASTM F 1862. The mask protects both patient and wearer from cross-contamination of microorganisms, body fluids, and particulates. It is a single-use, disposable device.

Clinical Evidence

No clinical data. Evidence consists of bench testing: NIOSH certification (42 CFR Part 84) for filtration efficiency (>95% average 98.95%) and breathing resistance; ASTM F 1862 for synthetic blood penetration (32/32 pass); 16 CFR 1610 for flammability (Class I); and biocompatibility (cytotoxicity, sensitization, irritation) based on predicate device data.

Technological Characteristics

Materials: Spunbond polypropylene, meltblown polypropylene filter, polyethylene foam nosepiece, non-latex rubber head strap. Design: Flat-fold style. Filtration: NIOSH-certified N95 (42 CFR Part 84). Fluid resistance: ASTM F 1862. Biocompatibility: ISO 10993-1 compliant. Sterilization: Not specified.

Indications for Use

Indicated for healthcare personnel during surgical procedures and for TB exposure control in healthcare facilities to protect patients and staff from microorganisms, body fluids, and particulates.

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

• Moldex-Metric Health Care N95 Particulate Respirators models 1511, 1512, 1513, 1517 (K061859)
• Moldex-Metric models 3001N95-S, 3002N95-M, 3003N95-L, & 3004N95-LP (K051182)

Submission Summary (Full Text)

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K102173
5-1

June 16, 2010

# Section 5. 510(k) Summary

## Submitter:

Moldex-Metric, Inc. 10111 W. Jefferson Blvd. Culver City, CA 90232-3509

## Contact:

SEP 1 3 2010

Mark Meinecke Director Quality Assurance Telephone: [phone] x705 Fax: [phone] E-mail: [e-mail]

## Trade Name:

Model 1712 Moldex-Metric Type N95 Healthcare Particulate Respirator and Surgical Mask

## Common Name:

Health Care N95 Particulate Respirator and Surgical Mask.

## Classification:

Name - Surgical Apparel, as described in 21 CFR 878.4040. Device Class - Class II Product Code - MSH CFR Section - 21 CFR 878.4040

## Substantial Equivalency:

The model 1712 Moldex-Metric Type N95 Healthcare Particulate Respirator and Surgical Mask is found to be substantially equivalent to Moldex-Metric Health Care N95 Particulate Respirators models 1511, 1512, 1513, 1517 [(510(k) K061859] and models 3001N95-S, 3002N95-M, 3003N95-L, & 3004N95-LP [(510(k) K051182)] . These products have also been tested and approved by NIOSH as N95 Respirators.

## Guidance Documents

Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submissions; Guidance for Industry and FDA.

Device Description, Intended Use, Limitations, Comparisons of Predicate Devices, Risks to Health, Exclusions from Standards, & Performance Tests have all been included in this Summary Report as per the Guidance Document.

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## 510(k) Summary (Continued)

Description:

The Moldex-Metric type N95 Healthcare Particulate Respirators and Surgical Masks are constructed from an extruded plastic mesh used in the outer cover and a nonwoven spunbond used in the inner and outer cover. The polypropylene melt blown filter media is layered between the inner and outer cover. The head strap is made of a non-latex rubber stapled to the mask. The inside nosepiece is a closed cell foam.

The model 1712 Moldex-Metric Type N95 Healthcare Particulate Respirator and Surgical Mask is approved by NIOSH in accordance with 42 CFR Part 84. The certification numbers is TC-84A-5227.

The type N95 must meet the prescribed test criteria which specifies the use of 0.055 to 0.095 micron diameter challenge and requiring a 95% efficiency or better and was tested by NIOSH in accordance with 42 CFR Part 84. The masks are resistant to synthetic blood as per ASTM F 1862 Standard Test method for Resistance of Medical Face Mask to Penetration by Synthetic Blood. Breathing resistance was tested by NIOSH in accordance to 42 CFR Part 84. The device has a Bacterial Filtration Efficiency greater than 99.9%. Testing was conducted using the Modified Green and Vesley Method for evaluation of bacterial filtration efficiency of surgical masks for the predicate devices.

Intended Use:

The model 1712 Moldex-Metric Type N95 Healthcare Particulate Respirator and Surgical Mask meets CDC Guidelines for TB Exposure Control within healthcare facilities. This device is also intended to be worn by healthcare personnel during surgical procedures to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material.

Limitations:

This product does not eliminate the wearer from any risk of contracting any type of disease or infection. The mask should be changed immediately if contaminated with blood or body fluids.

Comparison of Predicate Devices:

The outside cover of the previously cleared devices models 3001N95-S, 3002N95-M, 3003N95-L & 3004N95-LP incorporate a non-woven polypropylene material with a layer of an extruded plastic mesh and the Moldex-Metric models 1511, 1512, 1513, 1517 and new submitted model 1712 incorporate an extruded plastic mesh without the nonwoven material on the outer cover. The head strap color of the cleared device is the same as the Moldex-Metric device models for which clearance is being requested.

Moldex-Metrix model 1712 is only differs from the previously submitted models in that it has been designed as a flat fold type.

The Moldex-Metric type N95 Healthcare Particulate Respirators and Surgical Masks incorporate a highly efficient filter media and is 95% efficiency or better against aerosols that have a count median diameter of 0.055 - 0.095 microns which was scientifically established as the most penetrating particle size. The legally marketed devices previously cleared 510(k) are manufactured from similar materials.

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| Description | Moldex-Metric Health Care N95<br>Particulate Respirator and<br>Surgical Mask, model 1712 | Moldex-Metric Health Care N95<br>Particulate Respirators and<br>Surgical Masks, models 1511,<br>1512, 1513, 1517<br>(510k #K061859) | Moldex-Metrix Health Care N95<br>Particulate Respirators and Surgical<br>Masks, models 3001N95-S, 3002N95-<br>M, 3003N95-L, 3004N95-LP<br>(510k #K051182) |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Materials<br>Outer Cover Fabrics | Spunbond polypropylene,<br>Meltblown polypropylene | Spunbond polypropylene,<br>Meltblown polypropylene | Spunbond polypropylene, Meltblown<br>polypropylene |
| Nosepiece | Polyethylene foam | Polyethylene foam | Polyethylene foam |
| Headband | Various colors elastic, latex free | Various colors elastic, latex free | Various colors elastic, latex free |
| Specification &<br>Dimensions | Medium/Large size (5 1/2" x 5<br>1/16") | Various sizes (4.75" - 5.625"<br>circumference) | Various sizes (4.75" - 5.625"<br>circumference) |
| Mask Style | Molded Cup/Flat Fold | Molded Cup | Molded Cup |
| Design Features | Dual synthetic rubber | Dual synthetic rubber | Dual synthetic rubber |
| NIOSH Certification# | TC-84A-5227 | TC-84A-0013 | TC-84A-4102 |
| Intended Use | The model 1712 Moldex-Metric<br>Type N95 Healthcare<br>Particulate Respirator and<br>Surgical Mask meets CDC<br>Guidelines for TB Exposure<br>Control within healthcare<br>facilities. This device is also<br>intended to be worn by<br>healthcare personnel during<br>surgical procedures to protect<br>both the patient and healthcare<br>personnel from the transfer of<br>microorganisms, body fluids and<br>particulate material. | The various models of Moldex-<br>Metric Type N95 Healthcare<br>Particulate Respirators and<br>Surgical Masks meet CDC<br>Guidelines for TB Exposure<br>Control within healthcare<br>facilities. These devices are also<br>intended to be worn by<br>healthcare personnel during<br>surgical procedures to protect<br>both the patient and healthcare<br>personnel from the transfer of<br>microorganisms, body fluids and<br>particulate material. | The various models of Moldex-Metric<br>Type N95 Healthcare Particulate<br>Respirators and Surgical Masks meet<br>CDC Guidelines for TB Exposure<br>Control within healthcare facilities.<br>These devices are also intended to be<br>worn by healthcare personnel during<br>surgical procedures to protect both the<br>patient and healthcare personnel from<br>the transfer of microorganisms, body<br>fluids and particulate material. |

#### nd Predicate Devices Descriptions/ Comparisons Dovice

## Risks to Health

| Performance<br>Characteristics | Test Method | Acceptance criteria/ Results | Predicate Device Results | Predicate Device Results |
|---------------------------------------------------|--------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| | | Moldex-Metric Health Care<br>N95 Particulate Respirator and<br>Surgical Mask | Moldex-Metric Health Care<br>N95 Particulate Respirators<br>and Surgical Masks various<br>models (4) | Moldex-Metrix Health Care<br>N95 Particulate Respirators<br>and Surgical Masks various<br>models (4) |
| Fluid Resistance<br>Performance | ASTM 1862<br>- 00a | Model 1712<br>32 of 32 pass | Models 1511, 1512, 1513 and<br>1517<br>32 of 32 pass | Models 3001N95-S, 3002N95-<br>M, 3003N95-L, 3004N95-LP<br>32 of 32 pass |
| Flammability<br>Class * | 16 CFR 1610 | *Flame spread must be within<br>upper and lower limits/ No<br>flame spread on 10 of 10<br>samples, meets Class I | Flame spread must be within<br>upper and lower limits/ No<br>flame spread on 10 of 10<br>samples, meets Class I | Flame spread must be within<br>upper and lower limits/ No<br>flame spread on 10 of 10<br>samples, meets Class I |
| Filter Efficiency<br>(%) | NIOSH, 42<br>CFR<br>Part 84 | > 95% Efficient/ average<br>98.95% efficient of 20 samples | > 95% Efficient/ average<br>98.58% efficient of 17 samples | > 95% Efficient/ average<br>99.11% efficient of 20 samples |
| Inhalation<br>Breathing<br>Resistance<br>(mm H2O) | NIOSH, 42<br>CFR<br>Part 84 | < 35.0 mm H2O @ 85 lpm/<br>average 8.9 mm H2O @ 85<br>Ipm of 3 samples | < 35.0 mm H2O @ 85 lpm/<br>average 10.3 mm H2O @ 85<br>Ipm of 3 samples | < 35.0 mm H2O @ 85 lpm/<br>average 11.3 mm H2O @ 85<br>Ipm of 3 samples |
| Exhalation<br>Breathing<br>Resistance<br>(mm H2O) | NIOSH, 42<br>CFR Part 84 | < 25.0 mm H2O @ 85 lpm/<br>average 8.9 mm H2O @ 85<br>Ipm of 3 samples | < 25.0 mm H2O @ 85 lpm/<br>average 9.9 mm H2O @ 85<br>Ipm of 3 samples | < 25.0 mm H2O @ 85 Ipm/<br>average 16.9 mm H2O @ 85<br>Ipm of 5 samples |
| Biocompatibility * | ISO 10993-<br>1 | Cytotoxicity<br>Score of 2 or less/score of 0 | Cytotoxicity<br>Score of 2 or less/score of 0 | Cytotoxicity, score of 2 or less/<br>Score of 0 |
| | | Sensitization, Grade 1 (no<br>different than control)/Grade 1 | Sensitization, Grade 1 (no<br>different than control)/Grade 1 | Sensitization, Grade 1 (no<br>different than control)/ Grade 1 |
| | | Primary Skin Irritation<br>Negligible/Negligible | Primary Skin Irritation<br>Negligible/Negligible | Primary Skin Irritation,<br>Negligible/Negligible |
| Bacterial Filtration<br>Efficiency * | Modified<br>Greene and<br>Vesley<br>Method. J<br>Bacteriol<br>93:663.667 | Test results show a bacterial<br>filtration efficiency greater<br>than 99.9% | Test results show a bacterial<br>filtration efficiency greater<br>than 99.9% | Greater than 99.9% |

.

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Risk analysis is the same as the predicate devices. Approved under K061859 and K051182 the surgical mask device and the predicate device are made from the same material. The design of the mask with fold features was tested for Fluid Resistant in accordance with ASTM F 1862@ 160mmHg. All 32 of 32 pass and any risks would have been exposed at Fluid Resistant Testing.

## Exclusions from Standards*

In accordance with ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and Testing (Third Edition, 2003-08-01), Table 1 - Initial evaluation of tests for consideration, since contact duration is A-Limited (<24 h), only the Cytotoxicity, Sensitization, and Irritation or Intracttaneous Reactivity tests were performed.

#### Performance Tests:

This product was tested and certified by NIOSH as an approved N95 Respirator. It meets all the requirements prescribed in 42 CFR Part 84 and is assigned TC-84A-5227

## Tests Performed

- 1. Fluid Resistance Resistance of Liquid (Synthetic Blood Penetration Resistance) ASTM F 1862.
- 2. Filtration Efficiency (Particulate and Bacterial) 42 CFR Part 84
- 3. Differential Pressure (Delta P) Breathing Resistance 42 CFR Part 84
- 4. Flammability* 16 CFR 1610 (Class 1)
- Biocompatibility* (tested on predicate devices) న్.
- Cytotoxicity .
- Sensitization .
- Irritation .
- Bacterial Filtration Efficiency* Modified Greene and Vesley Method. J રું. Bacteriol 83:663-667.

* Tests were conducted on Predicate Devices which are made from the same material as models identified in this 510(k) submission.

### Safety/ Effectiveness:

The device has a fittration equivalent to the previously cleared Moldex-Metric N9S Particulate Respirator and The uevice has a mination opervation to the provised on the vare NOSH approved and meet the CDC guidelines for TB exposure control.

Conclusion:

The basic construction and material used in the cleared devices are the same as in the new device. The cleared devices and the new device are also approved by NTOSH, and meets all other required tosts. The Moldex-Metric type N95 Healthcare Paticulate Respirator and Surgical Mask is substantially equivalent to those listed on page 11 - 4.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

#### Public Health Service

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

Moldex/Metric, Incorporated C/O Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

SEP 1 3 2010

Re: K102173

Trade/Device Name: Model 1712 Moldex-Metric Type N95 Healthcare Particulate Respirator Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II

Product Code: MSH

Dated: August 26, 2010 Received: August 31, 2010

Dear Mr. Lehtonen:

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. Lehtonen

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 (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 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.

h 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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# Section 4. Indications for Use

# SEP 1 8 2010

K102173

4 - 1

510(k) Number (if known):

Device Name: Model 1712 Moldex-Metric Type N95 Healthcare Particulate Respirator and Surgical Mask

Indications for Use: The model 1712 Moldex-Metric Type N95 Healthcare Particulate Respirator and Surgical Mask meets CDC Guidelines for TB Exposure Control within healthcare facilities. This device is also intended to be worn by healthcare personnel during surgical procedures to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material.

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

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)

Edith F. Clavise-Wille

(Division Sign-Off) (Division Sign-Un)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division of Anton Control, Dental Devices

510(k) Number: K102173