The various models of Moldex Type N95 Healthcare Particulate Respirators and Surgical Masks meet CDC Guidelines for TB Exposure Control within healthcare facilities. These devices are 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 Description

The Moldex 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 fitter media is layered between the inner and outer cover. The head straps are made of a non-latex rubber stapled to the mask, The inside nosepiece is a closed cell foam.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Moldex Health Care N95 Particulate Respirators and Surgical Masks, based on the provided text:

Acceptance Criteria and Device Performance

Performance Characteristics	Test Method	Acceptance Criteria	Reported Device Performance (Moldex Health Care N95 Particulate Respirators and Surgical Masks)
Fluid Resistance Performance	ASTM 1862-00a	32 of 32 pass	32 of 32 pass
Flammability Class	16 CFR 1610	Flame spread must be within upper and lower limits / Meets Class 1	No flame spread on 10 of 10 samples, meets Class I
Filter Efficiency (%)	NIOSH, 42 CFR Part 84	> 95% Efficient	Average 96.81% efficient of 20 samples
Breathing Resistance (mm H₂O)	NIOSH, 42 CFR Part 84	< 35.0 mm H₂O @ 85 lpm	Average 10.2 mm H₂O @ 85 lpm of 3 samples
Biocompatibility (Cytotoxicity)	ISO 10993-5 (tested on predicate devices)	Score of 2 or less	Same as predicate device (Predicate device score of 0, so Moldex also meets this)
Biocompatibility (Sensitization)	ISO 10993-10 (tested on predicate devices)	Grade 1 (no different than control)	Same as predicate device (Predicate device Grade 1, so Moldex also meets this)
Biocompatibility (Primary Skin Irritation)	ISO 10993-10 (tested on predicate devices)	Negligible	Same as predicate device (Predicate device Irritation Negligible, so Moldex also meets this)
Bacterial Filtration Efficiency	Modified Greene and Vesley Method. J Bacteriol 83:663-667.	Greater than 99.9%	Test results show a bacterial filtration efficiency greater than 99.9%

Study Details

Sample sizes used for the test set and data provenance:
- Fluid Resistance Performance: 32 samples (number of individual masks tested). Data provenance is not specified, but typically these are laboratory tests performed on samples from production batches.
- Flammability Class: 10 samples. Data provenance is not specified.
- Filter Efficiency (%): 20 samples. Data provenance is not specified.
- Breathing Resistance (mm H₂O): 3 samples. Data provenance is not specified.
- Biocompatibility (Cytotoxicity, Sensitization, Primary Skin Irritation): Tested on unspecified number of predicate devices. Data provenance is not specified.
- Bacterial Filtration Efficiency: Not explicitly stated, but the test results show "a bacterial filtration efficiency greater than 99.9%". This would involve testing multiple samples. Data provenance is not specified.
All tests are laboratory-based performance evaluations, not clinical studies involving human subjects in particular countries. They are inherently prospective tests performed on samples of the device to demonstrate compliance with standards.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This report describes the results of physical and performance testing of a medical device (respirators/surgical masks) against established industry standards and regulatory requirements. It does not involve "experts" establishing a "ground truth" in the way one might for diagnostic imaging interpretation. The "ground truth" is defined by the objective measurement criteria of the specified test methods (e.g., ASTM F1862 for fluid resistance, NIOSH 42 CFR Part 84 for filter efficiency). The laboratories performing these tests are accredited for these specific testing methodologies, and their expertise lies in conducting these technical measurements accurately according to protocol.
Adjudication method for the test set:
Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human interpretation or subjective assessment is a component of ground truth determination (e.g., grading medical images). This document describes objective performance testing.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is not a study involving human readers or AI assistance; it's a device performance and safety evaluation.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This document pertains to physical device performance, not algorithm performance.
The type of ground truth used:
The "ground truth" is defined by the objective, quantitative measurements and pass/fail criteria established by standardized test methods (e.g., ASTM, NIOSH, ISO). For instance, for filter efficiency, the ground truth is simply whether the filter achieved >95% efficiency when tested according to NIOSH 42 CFR Part 84.
The sample size for the training set:
Not applicable. This document describes the testing of finished products, not the development or training of an algorithm.
How the ground truth for the training set was established:
Not applicable. There is no algorithm training set discussed in this document.

Summary

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Image /page/0/Picture/0 description: The image contains a sequence of handwritten digits and letters. The sequence appears to be 'K062663'. The characters are written in black ink on a white background. The handwriting style is casual and slightly uneven.

Image /page/0/Picture/1 description: The image shows the word "MOLDEX" in a bold, sans-serif font. Below the word "MOLDEX" is the phrase "ideas that work well" in a smaller, lighter font. The text is slightly blurred, giving it a textured appearance. The overall design is simple and clean, with a focus on the brand name.

MOLDEX-METRIC, INC. 10:11 West Jefferson Boxlevard. Culver City, Ceilfornia 90232 TEL 310-837-6500 FAX 310-837-9563 www.moldex.com

August 11, 2006

12 - 1

510(k) Summary

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

OCT 1 1 2006

Contact:

William Wawrzyniak Director Quality Assurance Telephone: 310-837-6500 Ext. 705 Fax: 310-837-0468 E-mail: williamw(@moldex.com

Trade Name:

Moldex Health Care N95 Particulate Respirators and Surgical Masks, various models

Common Name:

Health Care N95 Particulate Respirators and Surgical Masks

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:

Moldex Health Care N95 Particulate Respirators and Surgical Masks are found to be substantially equivalent to Inovel Health Care N95 Particulate Respirators and Surgical Masks models 1511, 1512, 1517 [(510(k) K061859] and 3001N95-S, 3002N95-M, 3003N95-L. 3004N95-LP [(510(k) K051182]. These products have also been tested and approved by NIOSH as N95 Respirators.

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KC 6263

MOLDEX-METRIC, INC.

10111 West Jefferson Boulevard, Culver Dity, California 90232 TEL 310-837-6500 FAX 310-837-9563 www.moldex.com

Image /page/1/Picture/3 description: The image shows the word "MOLDEX" in a stylized font. Below the word "MOLDEX" is the phrase "ideas that wear well." The text is in a dark color, contrasting with the background.

510(k) Summary (Continued)

12 - 2

Description:

The Moldex type N95 Healthcare Particulate Respirators and Surgical Masks are approved by NIOSH in accordance with 42 CFR Part 84. The certification number is TC-84A-4339.

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

Intended Use;

The various models of Moldex Type N95 Healthcare Particulate Respirators and Surgical Masks meet CDC Guidelines for TB Exposure Control within healtheare facilities. These devices are 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:

These products do 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 incorporate an extruded plastic mesh or a nonwoven polypropylene material with a layer of an extruded plastic mesh and the Moldex models 2211GN95-S, 2212GN95-M/L and 2217GN95-LP an extruded plastic mesh on the outside cover. The head strap color of the cleared device is the same as the Inovel device models for which clearance is being requested.

The Inovel 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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Image /page/2/Picture/0 description: The image contains handwritten text that appears to read "KOL 2663". The characters are written in a cursive style, with some connections between the letters. The text is slightly slanted and has varying stroke thicknesses, suggesting it was written with a pen or marker.

Image /page/2/Picture/1 description: The image shows the word "MOLDEX" in a bold, sans-serif font. Below the word "MOLDEX" is the phrase "Ideas that wear well." in a smaller, lighter font. The text appears to be slightly pixelated, giving it a textured look. The overall impression is of a logo or brand name with a tagline.

MOLDEX-METRIC. INC.

19111 West Jatterson Boulevard. Culver City, California 90232 FAX 310-837-9563 www.moldex.com TEL 310-837-5500

12-3

510(k) Summary (continued)

Device and Predicate Devices Descriptions/ Comparisons

Description	Moldex Health Care N95Particulate Respirators andSurgical Masks, models2211GN95-S, 2212GN95-M/L,2217GN95-LP	Inovel Health Care N95Particulate Respirators andSurgical Masks, models 1511,1512, 1513, 1517	Inovel Health Care N95Particulate Respirators andSurgical Masks, models3001N95-S, 3002N95-M,3003N95-L, 3004N95-LP
Materials
Outer CoverFabrics	Ethylene-Vinyl AcetateCopolymer, extruded	Ethylene-Vinyl AcetateCopolymer, extruded	Polypropylene Spunbond andEthylene-Vinyl AcetateCopolymer, extruded
Nosepiece	Polyethylene foam	Polyethylene foam	Polyethylene foam
Headband	Various colors elastic, latex free	Various colors elastic, latex free	Various colors elastic, latex free
Specification &Dimensions	Overall width: 5 - 5 5/8 inchesOverall height:4 3/4 - 5 1/2 inches	Overall width: 5 - 5 5/8 inchesOverall height:4 3/4 - 5 1/2 inches	Overall width: 5 - 5 5/8 inchesOverall height:4 3/4 - 5 1/2 inches
Mask Style	Molded Cup	Molded Cup	Molded Cup
Design Features	Dual synthetic rubber headstraps	Dual synthetic rubber head straps	Dual synthetic rubber headstraps
NIOSH Certification#	TC-84A-4339	TC-84A-0013	TC-84A-4102

Risks to Health

PerformanceCharacteristics	Test Method	Acceptance criteria/ Results	Predicate Device Results	Predicate Device Results
		Moldex Health Care N95Particulate Respirators andSurgical Masks variousmodels (3)	Inovel Health Care N95Particulate Respirators andSurgical Masks models 1511,1512, 1513, 1517	Inovel Health Care N95Particulate Respirators andSurgical Masks models3001N95-S, 3002N95-M,3003N95-L, 3004N95-LP
Fluid ResistancePerformance	ASTM 1862 -00a	32 of 32 pass	Models 1511, 1513 and 151732 of 32 passModel 151231 of 32 pass	32 of 32 pass
Flammability Class	16 CFR 1610	Flame spread must be withinupper and lower limits/ Noflame spread on 10 of 10samples, meets Class I	Flame spread must be withinupper and lower limits/ Noflame spread on 10 of 10samples, meets Class I	Flame spread must be withinupper and lower limits/ Noflame spread on 10 of 10samples, meets Class I
Filter Efficiency (%)	NIOSH, 42 CFRPart 84	> 95% Efficient/ average96.81% efficient of 20samples	> 95% Efficient/ average98.58% efficient of 17samples	> 95% Efficient/ average99.11% efficient of 20samples
BreathingResistance(mm H₂O)	NIOSH, 42 CFRPart 84	< 35.0 mm H₂O @ 85 lpm/average 10.2 mm H₂O @ 85lpm of 3 samples	< 35.0 mm H₂O @ 85 lpm/average 10.3 mm H₂O @ 85lpm of 3 samples	< 35.0 mm H₂O @ 85 lpm/average 11.3 mm H₂O @ 85lpm of 3 samples
Biocompatibility *	ISO 10993 - 1	CytotoxicitySame as predicate device	Cytotoxicity, score of 2 orless/ Score of 0	Cytotoxicity, score of 2 orless/ Score of 0
		SensitizationSame as predicate device	Sensitization, Grade 1 (nodifferent than control)/ Grade1	Sensitization, Grade 1 (nodifferent than control)/ Grade1
		Primary Skin IrritationSame as predicate device	Primary Skin Irritation,Negligible/Negligible	Primary Skin Irritation,Negligible/Negligible
Bacterial FiltrationEfficiency	Modified Greeneand VesleyMethod. JBacteriol 83:663-667.	Test results show a bacterialfiltration efficiency greaterthan 99.9%	Test results show a bacterialfiltration efficiency greaterthan 99.9%	Test results show a bacterialfiltration efficiency greaterthan 99.9%

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

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Image /page/3/Picture/0 description: The image shows the word "MOLDEX" in a textured font. Below the word "MOLDEX" is the phrase "Ideas that is our Wi-fi". The text is in a dark color, contrasting with the white background. The image appears to be a logo or branding element.

MOLDEX-METAIC、INC 1911: Wast selfrison Satievard Suiver Sat. FAx 310-837-9563 Parse mailies & 151 310-837-6500

12 -- 4

510(k) Summary (Continued)

Performance Tests:

These products were 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-4339

Tests Performed

Laboratory

Nelson Laboratories

Northview

Pacific

(Coordinated by Nelson Laboratories)

Laboratories,

Laboratories.

Inc.

1. Fluid Resistance Resistance of Liquid Moldex-Metric Inc. (Synthetic Blood Penetration Resistance) ASTM F 1862.
(Particulate and NIOSH Efficiency Filtration ni Bacterial) 42 CFR Part 84
Differential Pressure (Delta P) Breathing NIOSH 3. Resistance 42 CFR Part 84
Nelson Laboratories 4. Flammability 16 CFR 1610 (Class I)
Biocompatibility* (tested on র্থ predicate devices)
- Cytotoxicity (ISO 10993-5) .
  - Sensitization (ISO 10993-10) *
- Irritation (ISO 10993-10) .
- (Coordinated by Nelson Laboratories) Nelson Laboratories Bacterial Filtration Efficiency

Modified Greene and Vesley Method. J 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 devices have a filtration equivalent to the previously cleared Inovel LLC N95 Particulate Respirators and Surgical masks models 1511, 1512, 1513, 1517 510(k) number K061859 and Models 3001N95-S, 3002N95-M, 3003N95-L and 3004N95-LP 510(k) number K051182. They are NIOSH approved and meet the CDC guidelines for TB.

Conclusion:

The basic construction and material used in the cleared devices are the same as in the new devices. The cleared devices and the new devices are also approved by NIOSH, and meets all other required tests. The Moldex type N95 Healthcare Particulate Respirators and Surgical Masks are substantially equivalent to those listed on page 2 - 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 with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle. The logo is black and white and has a simple, clean design. The eagle is facing to the right.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Moldex-Metric, Incorporated C/O Mr. Neil E. Devine, Jr. Responsible Third Party Official Intertek Testing Services 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

OCT 1 1 2006

Re: K062663

Trade/Device Name: Moldex Health Care N95 Particulate Respirators and Surgical Mask, Models 2211GN95-S, 2212GN95-M/L, 2217GN95-LP Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: II Product Code: MSH Dated: September 28, 2006 Received: September 29, 2006

Dear Mr. Devine:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Devine

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Clive

Chiu Lin, Ph.D. 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): K (002 Lle L 3

Device Name: Health Care N95 Particulate Respirators and Surgical Masks, models 2211GN95-S, 2212GN95-M/L, 2217GN95-LP

Indications for Use:

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 1

Stella A. Murphy, D 10/1/04
Division Sign-Off

ision of Anesthesiology. General Hospital misction Control, Dental Devices

Number: Y042 663

Regulation Number and Section

§ 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.