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CERTIFICATION & SPECIFICATIONS
Specifications - Gill™ Mask Reusable Respirator
Model (Sizes, Colours, SKU No.)
| Colour/ Size | White, Large | Black, Large | White, Regular | Black, Regular | Junior |
|
Size |
129mm(w) x 130mm(H) |
129mm(w) x 130mm(H) |
118mm(w) x 125mm(H) |
118mm(w) x 125mm(H) |
110mm(w) x 95mm(H) |
|
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SKU No. |
01CAW012 |
01CAB012 |
01AAW012 |
01AAB012 |
01CHW012 |
Material Data
| Components | Materials | Standards |
|
Face Piece |
|
ISO 10993-12:2012 |
|
Cartridge, Door, Body |
Polypropylene Homopolymer |
|
|
Strap |
Spandex, Nylon |
Not Applicable |
|
Buckle |
Acrylonitrile Butadiene Styrene |
Not Applicable |
Test Standards
| Components | Materials | Standards |
|
Fit Test |
Qualitative Fit Test (QLFT) using 3M Training and Fit Testing Case FT-20 with a Bitter (Bitrex®) Taste 3M™ Fit Test Solution FT-32 |
OSHA 29CFR1910.134(f) |
|
Carbon Dioxide Retention |
<1% (Result: 0.6%) |
Passed |
|
Flammability |
5 seconds under flame |
Passed |
|
Head Harness |
50N pull force for 10 seconds |
Passed |
|
Field of Vision |
60 degrees (Result: >60 degrees) |
Passed |
Regulatory Approval
Class A Medical Device notified to Health Science Authority (HSA) of Singapore.
Shelf-life
2 years
Content
- 1 x Gill Mask Reusable Respirator
- 2 x Cartridges
- Packaging with instructions
Specifications - Gill™ FP95 Filter
Material Data
| Gill™ FP95 Filter | Specifications | Standards |
|
Particulate Filtration Efficiency (PFE) |
> 95% (Result: 96% - 98%) |
GB2626:2007 |
|
Differential Pressure |
|
Passed |
|
Flammability |
5 seconds under flame |
Passed |
Regulatory Approval
Class A Medical Device notified to Health Science Authority (HSA) of Singapore.
SKU No.
04FC17-B10
Shelf-life
2 years
Size
40mm x 60mm
Content
10 x Gill™ FP95 Filter per pack
Specifications - Gill™ FS2 Filter
Material Data
| Gill™ FS2 Filter | Specifications | Standards |
|
Materials |
Pre-cut materials conform to EN 14683 Type IIR |
EN 14683: 2019 Type IIR |
|
Bacterial Filtration Efficiency (BFE) |
>98% (Result: 98% - 99%) |
EN 14683:2019 + AC:2019(E) Annex B |
|
Differential Pressure |
< 60 Pa/Cm² (Result: 20.8 Pa/Cm²) |
EN 14683:2019 + AC:2019(E) Annex C |
|
Blood Penetration |
> 16 kPa |
ISO 22609:2004 |
|
Microbial Cleanliness |
< 30 CFU/g (Result: <12 CFU/g) |
|
Regulatory Approval
- Class A Medical Device notified to Health Science Authority (HSA) of Singapore
- FDA Registeres
- Class 1, EU Medical Device Registration (EU) 2017/745 (materials)
SKU No.
04FC14-B10
Shelf-life
2 years
Size
40mm x 60mm
Content
10 x Gill™ FS2 Filter per pack
Facilities and Product Owner
| Facilities | Specifications | Standards |
|
Respirator & Filters manufacturing sites |
Quality Management System; |
|
Product Owner
Gill Lab Pte Ltd.
79 Ayer Rajah Crescent, #02-07, Singapore 139955
BECOME OUR DISTRIBUTOR
We are looking for distributors worldwide to grow our global footprints. Our aim is to pave the way towards a better and smarter mask to protect healthcare professionals, frontline workers and individuals with a better way to breathe.
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