(34 days)
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.
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.
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 | 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.
§ 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.