(736 days)
The SpectraShield 9500 Surgical N95 Respirator is a single use, disposable, surgical N95 respirator, embedded with a zeolite carrier containing a silver-copper agent on the outer layer and is not an antimicrobial drug. SpectraShield 9500 kills 99.99% of test bacteria after one hour of contact with the surface of the respirator. In vitro (laboratory) tests have demonstrated 99.99% kill on the surface of the outer layer of the respirator when tested in vitro against single isolates of the following test bacteria: Streptococcus pyogenes, MRSA (Methicillin Resistant Staphylococcus aureus), and Haemophilus influenzae, under tested contact conditions.
No clinical studies have been conducted comparing the ability of an untreated surgical N95 respirator and the SpectraShield model 9500 surgical N95 respirator to protect the wearer from infection, and the antibacterial treatment cannot effect pathogens that are inhaled around the edges of the respirator.
The SpectraShield 9500 Surgical N95 respirator is a single use device, intended for occupational use to protect against microorganisms, body fluids, and particulate material,
The SpectraShield model 9500 Surgical Respirator is a molded shape surgical respirator composed of 4 layers of material, molded to form the respirator. A 2-ply meltblown polypropylene middle layer is sandwiched by inner and outer layers of 100% polyester nonwoven fabric. The inner and outside layers of polyester nonwoven fabric include fibers that have been embedded with an antimicrobial agent to provide antimicrobial performance. The respirator has 2 latex-free non-allergenic elastic straps and an aluminum nose strip.
Here's an analysis of the acceptance criteria and study information for the SpectraShield model 9500 Surgical Respirator based on the provided text:
Device: SpectraShield model 9500 Surgical Respirator
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (from predicate/guidance) | SpectraShield 9500 Performance |
|---|---|---|
| Fluid Resistance (ASTM F1862) | Fluid Resistant | Pass: Fluid Resistant @ 160mm Hg |
| Particulate Filtration Efficiency (ASTM F2299) | - | Pass: 99.87% at 0.1 microns |
| Differential Pressure (Mil M36954C) | - | Pass: 4.3mm H20/cm2 |
| Bacterial Filtration Efficiency (ASTM F2101) | - | Pass: 99.9% |
| Flammability Class (16CFR 1610) | Class 1 | Class 1 |
| Cytotoxicity (ISO 10993-10) | Score |
§ 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.