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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:

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