The First Product Classfied
as an “Endoscope Face Mask”
(GMDN 67755)
AeroKEE
AGP (Aerosol-genrating Procedure)
Procedural Solutions
TM
Single-use Patient-worn procedural source-control solutions built around NEMF, mitigating near-field exposure at the source during aerosol-generating procedures
Upper GI
Lower GI
Bronchoscopy
Nasal Endoscpy
· AeroKEE Single-use Endoscopy Mask · AeroKEE Single-use Colonoscopy Pants
Listed in · HSA Class I (Singapore) · ARTG Class I (Australia) · FDA Class II-Exempt (U.S.)
Endoscopic Exposure Is Real And Underestimated
Is AGP Limited to Bronchoscopy?
[1] Upper GI entered COVID-era AGP protection logic
[1] UK IPC Guidance, 2021
[2] Comparable aerosol burden to bronchoscopy reported in upper, lower GI and transnasal endoscopy
[2] Phillips et al., Gastrointestinal Endoscopy, 2022
Visualizing endoscopy-generated aerosols with laser light scattering (with videos)
Monica Passi, MD,1 Valentyn Stadnytskyi, PhD,2 Philip Anfinrud, PhD,2 Christopher Koh, MD, MHSc1
Bethesda, Maryland, USA
Do These Exposures
Reach the Operator?
- Enteric bacteria (Escherichia coli and Enterobacter cloacae) and oronasal flora were isolated from visors worn by endoscopists and assistants during gastrointestinal endoscopy.
- These findings demonstrate a measurable risk of facial contamination during endoscopic procedures.
[3] Nylander et al., Frontline Gastroenterology, 2023
What Exposures Exist Beyond Bioaerosols?
[4] ESD documented carcinogenic VOC / TVOC exposure
[5] Energy-based endoscopic resection elevated surgical smoke exposure [6] Surgical smoke fits a recognized occupational-hazard model
[4] Lim et al., Surg Endosc, 2021
[5] Walradt et al., Am J Gastroenterol, 2025
[6] Walradt et al., Am J Gastroenterol, 2025
Is Your Current Protection Aligned with the Risk?
-
Typical GI rooms operate at ~6 ACH, below AII benchmarks (~12 ACH)
-
No negative pressure or controlled airflow pathways in most settings
-
Advanced respiratory PPE not consistently applied in routine endoscopy
Protection Standards Lag Behind Evidence
If Protection Cannot Be Upgraded, How to Reduce Exposure Risk?
The most effective engineering controls:
"Remove or block the hazard at the source before it comes into contact with the worker"
“Containment of the aerosol at the source is the first level of engineering control”
NEMF (Near-field Exposure Mitigation Framework)
Based on the Principle of Source Control.
· AeroKEE Single-use Endoscopy Mask
Oral gastroscopy
Bronchoscopy
Transnasal gastroscopy
ENT nasal endoscopy
Bacterial Filtration Efficiency
Level 3
(ASTM F2100-19 / ASTM F2101-19)
· AeroKEE Single-use ColonoscopyPants
Routine Colonoscopy workflows
Impact Penetration/ Hydrostatic Force
Level 3
(AAMI PB70)
Maintains visual clarity throughout the procedure
Enables uninterrupted scope manipulation
Maintains seal during dynamic scope movement
Minimizes leakage during insertion and withdrawal
- Product use may vary by jurisdiction. Refer to local regulatory documentation.
- The results above are third-party test results for specific submitted samples; they describe material samples
rather than overall device performance across all clinical scenarios.
- Images shown are for illustration purposes only, actual product may vary
- Patent Pending in Multiple Jurisdictions, Singapore Application No. 10202503408P
Purpose-Built vs Retrofitted Solutions
Designed for procedural reality — not a retrofitted adaptation
AeroKEE Mask vs Modified Oxygen Mask
Purpose-built for real procedural workflows
— not adapted from oxygen masks
Key Aspect
AeroKEE Mask
Modified Oxygen Mask
Clinical Fit
Purpose-built for the majority of endoscopic procedures under sedation (nasal cannula) and ENT outpatient use; not for general anesthesia, positive-pressure oxygen delivery, or CO₂ monitoring
Modified from oxygen masks for use in anesthesia procedures
Breathability
Enables natural breathing
Relies on continuous oxygen supply
Filtration
Active filtration: PFE, BFE >98%
No filtration capability
Scope Interface
Dual-layer sponge interface with vertically offset slit design, enabling adaptive sealing around the scope and minimizing leakage
Single-layer PVC or silicone opening that cannot conform tightly to the scope, leading to an inadequate seal and leakage risk
Peak Event
Scope Withdrawal
Dual-slit sponge structure enables instant self-closing during withdrawal, helping contain high-flow aerosol release at the source
No dynamic closure during scope withdrawal, resulting in uncontrolled aerosol release
Peak Event
Coughing / Retching
Specially designed soft inner lining maintains a close facial seal even under sudden pressure surges caused by coughing or retching
Mask may lift off under sudden pressure, leading to leakage
AeroKEE Colonoscopy Pants vs Modified Drape
Purpose-built for insertion-site control
— not adapted from standard drapes
Key Aspect
AeroKEE Colonoscopy Pants
Colonoscopy Drape
Design
Purpose-built with integrated source control
Adapted from standard drapes with an added opening
Coverage
Full-body coverage with integrated interface
Surface coverage only
Visibility
Large transparent window for clear visualization
No visual access
Sealing
Elastic waist & leg cuffs help contain aerosol leakage
Loose surface coverage, no perimeter sealing
Fluid Handling
Absorbent design (~1000 mL) for fluid containment
Barrier only, no absorption
Interface
Dual-layer sponge port with adaptive sealing
Open access, no sealing
Aerosol Control
Near-field containment at source
No aerosol control
Stability
Fixed, stable positioning
Position-dependent, may shift