(42 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a respirator mask, with no mention of AI or ML technology.
No.
The device is a particulate respirator and surgical mask used for protection against transfer of microorganisms, body fluids, and particulate material, not for treating a disease or condition.
No
The device is a respirator and surgical mask, intended for protection against the transfer of microorganisms and particulate material, not for diagnosing conditions.
No
The device description clearly outlines the physical components of a respirator mask, including extruded plastic mesh, nonwoven spunbond, polypropylene melt blown filter media, a non-latex rubber head strap, and a closed cell foam nosepiece. The performance studies also focus on physical properties and filtration efficiency, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices that are used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Description and Intended Use: The provided information clearly describes a respirator and surgical mask. Its intended use is to protect healthcare personnel and patients from the transfer of microorganisms, body fluids, and particulate material during surgical procedures and to meet guidelines for TB exposure control. This is a physical barrier device used on the body, not a device used to test samples from the body.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples, detecting biomarkers, or performing diagnostic tests. The performance studies listed are related to the physical properties and filtration capabilities of the mask, not diagnostic accuracy.
Therefore, based on the provided information, the Moldex-Metric Type N95 Healthcare Particulate Respirator and Surgical Mask is a personal protective equipment (PPE) and a medical device, but it is not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
MSH
Device 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.
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
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:
- Fluid Resistance Resistance of Liquid (Synthetic Blood Penetration Resistance) ASTM F 1862.
- Filtration Efficiency (Particulate and Bacterial) 42 CFR Part 84
- Differential Pressure (Delta P) Breathing Resistance 42 CFR Part 84
- Flammability* 16 CFR 1610 (Class 1)
- Biocompatibility* (tested on predicate devices)
- Cytotoxicity
- Sensitization
- Irritation
- 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.
Key Results:
- Fluid Resistance Performance (ASTM 1862 - 00a): Model 1712: 32 of 32 pass.
- Flammability Class (16 CFR 1610): No flame spread on 10 of 10 samples, meets Class I.
- Filter Efficiency (%) (NIOSH, 42 CFR Part 84): > 95% Efficient/ average 98.95% efficient of 20 samples.
- Inhalation Breathing Resistance (mm H2O) (NIOSH, 42 CFR Part 84):
§ 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
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: 310-837-6500 x705 Fax: 310-837-0468 E-mail: mmeinecke@moldex.com
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.
1
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.
2
| Description | Moldex-Metric Health Care N95
Particulate Respirator and
Surgical Mask, model 1712 | Moldex-Metric Health Care N95
Particulate Respirators and
Surgical Masks, models 1511,
1512, 1513, 1517
(510k #K061859) | Moldex-Metrix Health Care N95
Particulate Respirators and Surgical
Masks, models 3001N95-S, 3002N95-
M, 3003N95-L, 3004N95-LP
(510k #K051182) |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Materials
Outer Cover Fabrics | Spunbond polypropylene,
Meltblown polypropylene | Spunbond polypropylene,
Meltblown polypropylene | Spunbond polypropylene, Meltblown
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 &
Dimensions | Medium/Large size (5 1/2" x 5
1/16") | Various sizes (4.75" - 5.625"
circumference) | Various sizes (4.75" - 5.625"
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
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. | The various models of Moldex-
Metric 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. | The various models of Moldex-Metric
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. |
nd Predicate Devices Descriptions/ Comparisons Dovice
Risks to Health
| Performance
| Characteristics | Test Method | Acceptance criteria/ Results | Predicate Device Results | Predicate Device Results |
|---|---|---|---|---|
| Moldex-Metric Health Care | ||||
| N95 Particulate Respirator and | ||||
| Surgical Mask | Moldex-Metric Health Care | |||
| N95 Particulate Respirators | ||||
| and Surgical Masks various | ||||
| models (4) | Moldex-Metrix Health Care | |||
| N95 Particulate Respirators | ||||
| and Surgical Masks various | ||||
| models (4) | ||||
| Fluid Resistance | ||||
| Performance | ASTM 1862 |
- 00a | Model 1712
32 of 32 pass | Models 1511, 1512, 1513 and
1517
32 of 32 pass | Models 3001N95-S, 3002N95-
M, 3003N95-L, 3004N95-LP
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
98.95% efficient of 20 samples | > 95% Efficient/ average
98.58% efficient of 17 samples | > 95% Efficient/ average
99.11% efficient of 20 samples |
| Inhalation
Breathing
Resistance
(mm H2O) | NIOSH, 42
CFR
Part 84 |