NIOSH N95 Respirator Surgical Masks - Made in USA

SKU #: ACI-SURG-N95-TC-84A-9318 (case)

RMID: 50320

Brand: Advanced Concept Innovations

BULK Surgical N95 Respirator Mask (mask only)
Effective seal causes air to exhale through the mask, not out the top
NIOSH N95 Respirator Surgical Mask shown with box
Won't fog protective eyewear or glasses
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Longitudinal View with head strap, neck strap
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Front view
Comes expertly packaged for your utmost peace of mind

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N95 Masks: FDA, CDC/NIOSH, ASTM Level III and ISO Certified, Ships Same Day!

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Category: N95 Masks

CDC/NIOSH/FDA approved N95 Mask for use with COVID positive patients in all hospitals & healthcare facilities. Tight facial-seal duckbill design! Won't fog glasses!

Made in USA and ships immediately from US facility
Elastomeric head strap design for best seal and most comfort
NIOSH certified N95 filtering facepiece respirator
Meets all ISO manufacturing standards
ASTM F1862 Level 3 fluid resistance
50 masks per box, 6 boxes per case

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List Price: ~~$220.15~~

Starts At: $153.95 (Save 30%)

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Rehabmart ID: 50320

MPN: SURG-N95-TC-84A-9318

Brand: Advanced Concept Innovations

Rehabmart is an authorized Advanced Concept Innovations dealer!

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Proudly made in America and available to ship within 24-hours of ordering, these Surgical N95 Respirators are NIOSH-approved and cleared by the FDA.

Possessing all available certifications and registrations (including ISO and ASTM Level III Certification), these are truly the ideal face masks to wear for optimal safety. Their unique duckbill-style design provides a tight seal around your face, yet is non-restrictive and won't trigger claustrophobia. The duckbill-style offers horizontal space and breathability due to its vertical breathing chamber, which protrudes away from your nose and mouth. This encourages air to exit through the front of your mask, rather than air escaping from the edges where it seals with your facial skin. Since air doesn't leak out around the edges, this design is especially appealing to users that wear glasses. No escaping air = no fogged-up glasses! No fogging of glasses is yet another verifiable safety marker that confirms for the user, that they have donned the mask properly, securing a firm seal around the borders where the fabric makes contact with the skin.

Not only are these masks ultra-comfortable, they offer the highest level of splatter/fluid penetration protection available (tested and rated up to 160 mmHg) and the highest level of N95 protection available. For your utmost convenience, all mask certification documents can be found below.

This ACI mask is unique because it meets the requirement of being both an FDA cleared Surgical Mask and a NIOSH tested and approved N95 Respirator. In order to achieve Surgical Mask status, the mask must meet stringent regulations as defined by the U.S. Food and Drug Administration (FDA). In order to achieve N95 Respirator protection levels, the mask must be evaluated, tested, and approved by NIOSH as per the Federal requirements outlined in 42 CFR Part 84. The ACI mask has cleared both FDA and NIOSH testing and certification standards. Below are links to both governmental certifications.

FDA Clearance

NIOSH-Approval

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Product Specifications / Dimensions

Specifiction Label	Specification Value
Quantity	300 masks
Packaging	50 masks per box / 6 boxes per case
ASTM	Level 3 maximum protection
FDA Registration #	3006015326
NIOSH Certified	TC-84A-9318
Flammability	Class 1
Color	Blue
Made in the USA	Yes
ISO 9001 2015	Certified
ISO 13485 2016	Certified
ISO 22716 2007	Certified
cGMP Compliant	Yes
USFDA Quality System Regulation (QSR)	Approved
NIOSH Registered Manufacturing Facility	Yes
FDA Registered Manufacturing Facility	Yes
Certified Cleanrooms	Yes
NIOSH 42 CFR 84	Yes

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Additional Documentation on This Product

Surgical N95 Respirator Mask: SPECIFICATIONS and DONNING INSTRUCTIONS

Understanding FDA Clearance and CDC/NIOSH Approval Process for Surgical N95 Respirators

Advanced Concept Innovations (ACI) Packaging Brochure

More Information

Fit matters! These Surgical N95 Respirators are designed in a way that provides an excellent seal without compromising on comfort. Their exceptional design really makes them stand out from the others. First, the duckbill-style offers breathability. The breathing chamber protrudes from your face, rather than lying up against it. This allows your breath to exit from the front of your mask instead of seeping out of the sides. In comparison, most masks provide wider coverage on your face, which forces air to escape around the edges. This issue has presented a problem to many users that wear glasses, as it causes glasses to fog - and not to mention that it's medically unsafe! This mask conquers that issue and glasses-wearing users can now all take a deep exhale without worrying about lack of visibility.

Another design feature that is worth mentioning are the masks' strong, ultrasonically bonded head straps. These straps are Coban-style and don't utilize painful staples. Both head straps are placed on the back of your head, rather than behind your ears - mitigating discomfort and ear strain. The stretchy straps are comfortably tight enough to stay secure in place but will not cause indentations in the head. This mask style is comfortable and won't irritate your skin, making it ideal for users of all ages and skin sensitivity levels.

These Surgical N95 Respirators are ideal for healthcare workers who require protection against the transfer of aerosolized solid and liquid particles. This model of respirator is specifically designed to protect the wearer from exposure to airborne particles, and they are Level 3 fluid-resistant. These masks, however, can be purchased and worn by anyone who desires superior protection.

This Respirator has been approved as a NIOSH N95 filtering facepiece Respirator. It is approve for use in all Healthcare Settings, as a Surgical N95 Respirator conforming to recognized standards for Biocompatibility, Flammability, and Fluid Resistance.

These masks boast:

FDA Clearance,

NIOSH-Approval

ASTM Level 3 Fluid Resistance, 160 mm Hg (highest level of protection)

Donning the N95 Duck-Billed Mask

About ACI

NIOSH N95 Respirator Surgical Masks - Made in USA Picture

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FAQ For NIOSH N95 Respirator Surgical Masks - Made in USA

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Are the Surgical N95 Respirator Masks latex-free?

Answer: Yes, they are! The components of this mask include polypropylene, polyurethane, and carbon wire.

Can I use the Surgical N95 Respirator Masks in my clinic?

Answer: This Respirator has been approved as a NIOSH N95 filtering facepiece Respirator, for use in Healthcare Settings, as a Surgical N95 Respirator conforming to recognized standards for Biocompatibility, Flammability, and Fluid Resistance.

Before occupational use of this Respirator, a written respiratory protection program must be implemented meeting all the local government requirements. In the United States, employers must comply with OSHA 29 CFR 1910.134 which includes medical evaluation, training, and fit testing.