Detmold Group is a leading manufacturer of paper and board based packaging products for a diverse range of customers.
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Who is the N95 Surgical Respirator Mask suitable for?
Our N95 Surgical Respirator Mask is a single-use, non-sterile surgical respirator for use in a healthcare environment where a person is at risk of blood or fluid splash. The N95 mask is designed to filter out non-oil-based airborne particulates and bacteria.
The Detmold Medical N95 face mask is suitable for use in healthcare and hospital settings that conduct fit checking procedures. These settings include but are not limited to operating theatres, emergency, infection control, oncology or haematology. See N95 mask instruction for use guides below.
Why choose the N95 Surgical Respirator Mask?
For Use in Healthcare and Hospital Environments
Australian Standards AS/NZS 4381:2015 and International Standard NIOSH 42 CFR Part 84
ARTG Register no. 382970
Single-Use Only
Available in FitClip™ or Head Bands for Easy Donning & Doffing
Available in 5 Sizes
+ Lightweight, flat-fold design that expands into a convex-shaped device.
+ Available with either head bands or two bands with and a FitClip™ to hold the N95 mask in place.
+ Two FitClip™ size options for those requiring a longer band.
N95 Surgical Respirator Mask Specifications
Performance Criteria
Designed and tested to meet a cross-section of global performance requirements of a P2 Class Respirator and an N95 Respirator specified by AS/NZS 1716:2012 Respiratory Protective Devices and the NIOSH 42 CFR Part 84.
| Characteristics | AS 1716:2012 | 42 CFR Part 84 | AS 4381:2015 |
| P2 | N95 | ||
| Quality Control | ISO 13485 | NIOSH | |
| Particulate Filtration Efficiency (PCE) | >94% NaCI, instantaneous | >95% NaCI, 200mg | |
| Exhalation Resistance | <120Pa at 85L/min | <25mmH20 at 85L/min | |
| Inhalation Resistance | <370Pa at 95L/min | <35mmH20 at 85L/min | |
| Facial Fit (Leakage) | <8% | ||
| Carbon Dioxide Clearance | ≤1% | ≤1% | |
| Flammability | 16 CFE 1610 | ||
| Biocompatibility | Compatible with skin | Compatible with skin | |
| Bacterial Filtration Efficiency | >98% | ||
| Blood Splash Resistance | Level 3 - 160mmHg |
Highlighted boxes indicate standards use in testing. Note: These performance requirements are measured on unworn masks. The mask may not meet these performance requirements during wear due to individual fit characteristics. Please consult your fit tesing procedure. This product is designed for use in a healthcare setting.
| + Designed and tested to meet a cross-section of global performance requirements | + Bacterial Filtration Efficiency (BFE) ≥98% - AS/NZS 4381:2015 |
| + Meets the essential principles of an N95 Respirator specified by the NIOSH 42 CFR Part 84 | + Facial Fit (TIL) - Class P2 AS/NZS 1716:2012, Section 2.2 |
| + Particulate Filtration Efficiency (PFE) ≥95% - 42 CFR Part 84, Subpart K | + Included on the Australian Register of Therapeutic Goods (ARTG 382970) |
| + Blood Splash Resistance Level 3 - AS/NZS 4381:2015 | + Non-sterile & latex-free head bands or FitClip™ and two bands to hold the N95 mask in place |
Available N95 Surgical Respirator Masks
Detmold Medical’s N95 Surgical Respirator Masks are available in five different sizes. Each size is available in Retail Packs of 20 masks or Bulk Packs containing 24 boxes of 20 N95 masks (480 masks).
Our N95 face mask products are available in a choice of head bands or two bands with a FitClip™.
For those requiring a longer band, you can buy the Extra Large size FitClip™ in retail or bulk packs.
N95 Surgical Respirator Mask Donning and Doffing Instruction Guides
The N95 Surgical Respirator Mask is designed for use in healthcare and hospital settings that conduct fit checking procedures. To achieve a comfortable and adequate seal, please download the relevant comprehensive donning and doffing guide below.#
#Caution: Mask helps protect against certain particles and is designed for occupational use by healthcare professionals who are properly trained in mask use and limitations. Misuse may result in sickness or death. DO NOT use in any manner not indicated in the Instructions for Use. Always read the label. Discard the mask if it becomes damp, soiled, damaged, or difficult to breathe through. Performance efficiencies may deteriorate when exposed to oil-based substances or individual fit characteristics are not adequate. Do not use if the packaging is damaged. Maximum operating temperature is +50°c.