(73 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration efficiency of a respirator mask, with no mention of AI or ML technologies.
No
The device is described as a "Healthcare Particulate Respirator and Surgical Mask" intended to protect both the patient and personnel from microorganisms and particulate material, which classifies it as a protective/barrier device, not a therapeutic one.
No
Explanation: The device is a respirator and surgical mask, intended for protection, not for diagnosing medical conditions.
No
The device description clearly outlines physical components (nonwoven material, polypropylene melt blown filter media, rubber headband, foam and aluminum nosepiece) and performance testing related to these physical attributes (particulate filtration, fluid resistance, breathing resistance). There is no mention of software as a component or function of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a respirator and surgical mask worn by operating room personnel to protect against microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed on a sample from the human body.
- Device Description: The description details the physical construction and materials of a mask, along with performance testing related to filtration efficiency and fluid resistance. There is no mention of reagents, assays, or any components used for analyzing biological samples.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (blood, urine, tissue, etc.)
- Detecting or measuring a substance in a sample
- Providing information for diagnosis, monitoring, or treatment decisions based on sample analysis.
The device is a personal protective equipment (PPE) designed to filter airborne particles and provide a barrier against fluids, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Gerson Isolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735 is 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.
This device also meets CDC Guidelines for "B Exposure Control.
Product codes
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Device Description
The Gerson Isolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735 is constructed from a white nonwoven material used in the inner and outer shell. The polypropylene melt blown filter media is layered between the inner and outer shell. The headband is made of rubber stapled to the mask. The inside nosepiece utilizes a closed cell foam and the outside nosepiece which conforms to the nose is made of aluminum.
The Gerson Isolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735 is approved by NIOSH as per 42 CFR 84. The certification number assigned is TC-84A-160 for a type N95 Particulate Respirator. The Type N95 must meet the prescribed test criteria which specifies the use of 0.3 micron diameter challenge and requiring a 95% efficiency. This mask is also fluid resistant as per (ASTM D583 65 Method) and is resistant to synthetic blood as per Protocol number 9602202-01 conducted by Nelson Laboratories. Breathing resistance was tested as per NIOSH 30 CFR11 section 11.140-9.
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
operating room personnel / operating room
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
This product was tested and certified by NIOSH as an approved N95 respirator. It meets all the requirements prescribed in 42 CFR 84 and is assigned TC-84A-160.
Tests Performed:
- Department of Health and Human Services 42 CFR 84 Type N95 Requirements - Performed by NIOSH
- Resistance to Liquid (Synthetic Blood Penetration Resistance) Protocol No. 9602202-01 - Performed by Nelson Laboratories
- Breathing Resistance 30 CFR 11 - Performed by NIOSH
- Fluid Resistance (ASTMD583-65 Method 1) - Performed by Gerson
- Filtration Efficiency NIOSH 42 CFR 1 - Performed by NIOSH
- Primary Skin Irritation - Performed by Gerson
- FHSA Primary Dermal Irritation - Performed by Nelson Laboratories
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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
510(K) Summary
MAY - 9 1996
Submitter
Louis M. Gerson Co., Inc. 15 Sproat Street Middleboro, MA 02346
Contact:
Joseph Z. Zdrok Technical Director Respiratory Protection
508-923-3017 or 508-947-4000 Telephone: 508-947-5442 Fax:
Date: January 5, 1996
Trade Name:
Gerson Isolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735
Common Name:
Healthcare Particulate Respirator and Surgical Mask
Classification
Device Class - Class II CFR Section - 21 CFR 878.4040
Substantial Equivalency:
The Gerson Isolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735 is found to be substantially equivalent to the Gerson Isolair SMF 510 (k) number K922507. The product is manufactured in the same manner but utilizes more efficient filter media.
1
510(K) Summary (Continued)
Description:
The Gerson Isolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735 is constructed from a white nonwoven material used in the inner and outer shell. The polypropylene melt blown filter media is layered between the inner and outer shell. The headband is made of rubber stapled to the mask. The inside nosepiece utilizes a closed cell foam and the outside nosepiece which conforms to the nose is made of aluminum.
The Gerson Isolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735 is approved by NIOSH as per 42 CFR 84. The certification number assigned is TC-84A-160 for a type N95 Particulate Respirator. The Type N95 must meet the prescribed test criteria which specifies the use of 0.3 micron diameter challenge and requiring a 95% efficiency. This mask is also fluid resistant as per (ASTM D583 65 Method) and is resistant to synthetic blood as per Protocol number 9602202-01 conducted by Nelson Laboratories. Breathing resistance was tested as per NIOSH 30 CFR11 section 11.140-9.
Intended Use:
The Gerson Isolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735 is 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.
This device also meets CDC Guidelines for "B Exposure Control.
Limitations:
This product does not eliminate the wearer trom any risk of contracting any type of disease or infection. The mask should be changed immediately if contaminated with blood or body fluids.
2
510(K) Summary (Continued)
Comparison of Predicate Device
The outside cover stock color of the previously cleared device is blue. The Gerson lsolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735 is white. The headband color of the cleared device is white and the Isolair APR Type N95 is green.
The Gerson Isolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735 incorporates a highly efficient filter media and is 95% efficient against a .3 micron particulate which was scientifically established as the most penetrating particle size. The legally marketed device previously cleared 510 (k) K922507 is manufactured from similar materials, but does not have the high efficiency characteristics as the new Isolair APR Type N95
Performance Tests:
This product was tested and certified by NIOSH as an approved N95 respirator. It meets all the requirements prescribed in 42 CFR 84 and is assigned TC-84A-160.
| Tests Performed | Laboratory | |
|---|---|---|
| 1. | Department of Health and Human | |
| Services 42 CFR 84 Type N95 | ||
| Requirements | NIOSH | |
| 2. | Resistance to Liquid (Synthetic | |
| Blood Penetration Resistance) | ||
| Protocol No. 9602202-01 | Nelson Laboratories | |
| 3. | Breathing Resistance 30 CFR 11 | NIOSH |
| 4. | Fluid Resistance (ASTMD583-65 | |
| Method 1) | Gerson | |
| 5. | Filtration Efficiency NIOSH 42 CFR 1 | NIOSH |
| 6. | Primary Skin Irritation | Gerson |
| 7. | FHSA Primary Dermal Irritation | Nelson Laboratories |
3
510(K) Summary (Continued)
Conclusion:
Since the basic construction is used in the cleared device as in the new device except for incorporation of a highly efficient filter media tested and approved by NIOSH, the Gerson Isolair APR Type N95 Healthcare Particulate Respirator and Surgical Mask Model 2735 is substantially equivalent to the Gerson SMF product.
Safety/Effectiveness
The device has a filtration much greater than the previously cleared Gerson SMF Surgical Mask Respirator. It is NIOSH approved and meets the CDC guidelines for TB Exposure Control.