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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)

SKU No.

01CAW012

01CAB012

01AAW012

01AAB012

01CHW012

Material Data

Components Materials Standards

Face Piece

  • Biocompatible Silicone Rubber
  • ELASTOSIL® LR 3038/50 Ki CN

ISO 10993-12:2012

Cartridge, Door, Body

Polypropylene Homopolymer

  • FDA 21 CFR 177.1520(a) 1(i)
  • FDA 21 CFR 177.1520(b)
  • FDA 21 CFR 177.1520 (c) 1.1a

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

  • Inhalation <350 Pa
  • Exhalation <250 Pa
    (Result: Inhalation and exhalation <120 Pa)

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)

  • EN 14683:2019 + AC:2019 (E) Annex D
  • EN ISO 11737-1:2008

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;
Medical Device Facility

  • ISO 13485:2016
  • ISO 9001:2015
  • AS100D
  • EN ISO 14971:2012
  • EN ISO 10993-1:2006
  • FDA Establishment Registration No:
    3016678422

Product Owner

Gill Lab Pte Ltd.
79 Ayer Rajah Crescent, #02-07, Singapore 139955

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