(34 days)
No
The device description and performance studies focus on material properties and physical performance, with no mention of AI or ML.
No
The device is a respirator and surgical mask intended to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material, not to treat a medical condition.
No
This device, a particulate respirator and surgical mask, is intended to protect against the transfer of microorganisms, body fluids, and particulate material; it does not diagnose any condition or disease.
No
The device description clearly outlines physical components like extruded plastic mesh, nonwoven spunbond, polypropylene melt blown filter media, rubber head straps, and closed cell foam, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "Healthcare Particulate Respirator and Surgical Mask" worn by healthcare personnel to protect against the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier device used on the body, not a test performed on a sample taken from the body.
- Device Description: The description details the physical construction of a mask, not a reagent, instrument, or kit used for testing.
- Performance Studies: The performance studies focus on the physical properties and filtration capabilities of the mask (fluid resistance, flammability, filter efficiency, breathing resistance, bacterial filtration efficiency), not on the accuracy or reliability of a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a personal protective equipment (PPE) designed to prevent the transmission of airborne particles and fluids.
N/A
Intended Use / Indications for Use
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.
Product codes
MSH
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.
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.
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
healthcare personnel / healthcare facilities
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Characteristics, Test Method, Acceptance criteria/ Results, Predicate Device Results, Predicate Device Results:
Fluid Resistance Performance: ASTM 1862 - 00a, 32 of 32 pass, Models 1511, 1513 and 1517 32 of 32 pass Model 1512 31 of 32 pass, 32 of 32 pass.
Flammability Class: 16 CFR 1610, Flame spread must be within upper and lower limits/ No flame spread on 10 of 10 samples, meets Class I, Flame spread must be within upper and lower limits/ No flame spread on 10 of 10 samples, meets Class I, Flame spread must be within upper and lower limits/ 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, > 95% Efficient/ average 98.58% efficient of 17 samples, > 95% Efficient/ average 99.11% efficient of 20 samples.
Breathing Resistance (mm H₂O): NIOSH, 42 CFR Part 84, 95% Efficient/ average 96.81% efficient
Bacterial Filtration Efficiency: greater than 99.9%
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/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.
1
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 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.
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.
2
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 N95
Particulate Respirators and
Surgical Masks, models
2211GN95-S, 2212GN95-M/L,
2217GN95-LP | Inovel Health Care N95
Particulate Respirators and
Surgical Masks, models 1511,
1512, 1513, 1517 | Inovel Health Care N95
Particulate Respirators and
Surgical Masks, models
3001N95-S, 3002N95-M,
3003N95-L, 3004N95-LP |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Materials | | | |
| Outer Cover
Fabrics | Ethylene-Vinyl Acetate
Copolymer, extruded | Ethylene-Vinyl Acetate
Copolymer, extruded | Polypropylene Spunbond and
Ethylene-Vinyl Acetate
Copolymer, 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 inches
Overall height:
4 3/4 - 5 1/2 inches | Overall width: 5 - 5 5/8 inches
Overall height:
4 3/4 - 5 1/2 inches | Overall width: 5 - 5 5/8 inches
Overall height:
4 3/4 - 5 1/2 inches |
| Mask Style | Molded Cup | Molded Cup | Molded Cup |
| Design Features | Dual synthetic rubber head
straps | Dual synthetic rubber head straps | Dual synthetic rubber head
straps |
| NIOSH Certification# | TC-84A-4339 | TC-84A-0013 | TC-84A-4102 |
Risks to Health
| Performance
| Characteristics | Test Method | Acceptance criteria/ Results | Predicate Device Results | Predicate Device Results |
|---|---|---|---|---|
| Moldex Health Care N95 | ||||
| Particulate Respirators and | ||||
| Surgical Masks various | ||||
| models (3) | Inovel Health Care N95 | |||
| Particulate Respirators and | ||||
| Surgical Masks models 1511, | ||||
| 1512, 1513, 1517 | Inovel Health Care N95 | |||
| Particulate Respirators and | ||||
| Surgical Masks models | ||||
| 3001N95-S, 3002N95-M, | ||||
| 3003N95-L, 3004N95-LP | ||||
| Fluid Resistance | ||||
| Performance | ASTM 1862 - | |||
| 00a | 32 of 32 pass | Models 1511, 1513 and 1517 | ||
| 32 of 32 pass | ||||
| Model 1512 | ||||
| 31 of 32 pass | 32 of 32 pass | |||
| Flammability Class | 16 CFR 1610 | Flame spread must be within | ||
| upper and lower limits/ No | ||||
| flame spread on 10 of 10 | ||||
| samples, meets Class I | Flame spread must be within | |||
| upper and lower limits/ No | ||||
| flame spread on 10 of 10 | ||||
| samples, meets Class I | Flame spread must be within | |||
| upper and lower limits/ 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 | > 95% Efficient/ average | |||
| 98.58% efficient of 17 | ||||
| samples | > 95% Efficient/ average | |||
| 99.11% efficient of 20 | ||||
| samples | ||||
| Breathing | ||||
| Resistance | ||||
| (mm H₂O) | NIOSH, 42 CFR | |||
| Part 84 |