FAQs PPE – Medical

ItemCHARACTERISTICSPerformance standards
Gloves,
examination, non-sterile
Gloves, examination, nitrile (preferable), latex, polychloroprene or PVC, powder-free, non-sterile.  (e. g., minimum 230mm total length). Minimum thickness 0.05mm. Sizes S, M, L.• EN 455,
• EN 374, optional additional:
• ASTM D6319, D3578, D5250, D6977

or alternative equivalent set of standards
Gloves, surgical, sterileGloves, surgical, nitrile (preferable), latex, polyisoprene, or polychloroprene, sterile, powder-free, single use. 

Gloves should have long cuffs, reaching well above the wrist, ideally to mid-forearm. minimum thickness 0.10mm. Sizes ranging 5.0 – 9.0.
• EN 455,
• ASTM D3577,

Sterility
• United States Pharmacopeia
• EN ISO 11607
or alternative equivalent set of standards 
Goggles, glasses
protective
Good seal with the skin of the face, Flexible PVC frame to easily fit with all face contours with even pressure,  Enclose eyes and the surrounding areas, Accommodate wearers with prescription glasses, Clear plastic lens with fog and scratch resistant treatments, Adjustable band to secure firmly so as not to become loose during clinical activity, Indirect venting to avoid fogging, May be re-usable (provided appropriate arrangements for decontamination are in place) or disposable.• EN 166,
• ANSI/ISEA Z87.1,
or alternative equivalent set of standards
Face shieldMade of clear plastic and providing good visibility to both the wearer and the patient.  Adjustable band to attach firmly around the head and fit snuggly against the forehead, fog resistant (preferable). Completely cover the sides and length of the face. May be re-usable (made of robust material which can be cleaned and disinfected) or disposable.• EN 166 (if reusable),
• ANSI/ISEA Z87.1 (if reusable),
or alternative equivalent set of standards 
Fit test kitTo evaluate effectiveness of seal for tight fitting respiratory protection devicesOSHA 29 CFR 1910.134 Appendix A
Particulate respiratorGood particle filtration (minimum 94% or 95%), good breathability with design that does not collapse against the mouth (e.g. duckbill, cup-shaped).
May be tested for fluid resistance (NIOSH/FDA surgical N95, EN 149 FFP2+Type IIR, GB 19083 Grade/Level 1)
Fluid resistant respirator:
• Minimum NIOSH approved (42 CFR Part 84) and FDA cleared “surgical N95”
• EN 149, minimum “FFP2” and EN 14683 Type IIR
• GB 19083, minimum “Grade/Level 1”,
or alternative equivalent standard
Non-fluid resistant respirator
• Minimum NIOSH approved”N95” according to 42 CFR Part 84
• EN 149, minimum “FFP2”
• GB 2626, minimum “KN95”
or alternative equivalent standard
Mask, medical -for healthcare workerMedical mask, good breathability, internal and external faces should be clearly identified, 98% droplet filtration, preferably fluid resistance.Fluid resistant masks (surgical masks):
• EN 14683 Type IIR
• ASTM F2100 Level 1, 2 or 3,
• YY 0469, with at least 98% bacterial droplet filtration
or alternative equivalent standard

Non-fluid resistant mask:
• EN 14683 Type II
• YY/T 0969, with at least 98% bacterial droplet filtration
or alternative equivalent standard
Mask, medical, for patientMedical mask, good breathability, internal and external faces should be clearly identified• EN 14683 Type I

 • YY 0469 or YY/T 0969, if bacterial droplet filtration is below 98%
or alternative equivalent standard
Scrubs, topsTunic/tops, woven, scrubs, reusable or single use, short sleeved (tunic/tops), worn underneath the coveralls or gown. 
Scrubs, pantsTrouser/pants, woven, scrubs, reusable or single use, worn underneath the coveralls or gown 
Apron, heavy dutyStraight apron with bib,
Fabric: 100% polyester with PVC coating, or 100% PVC, or 100% rubber, or 100% reusable and biodegradable material, or other fluid resistant coated material,
Waterproof, sewn strap for neck and back fastening or single-material cut film
Minimum basis weight: 300 g/m2,
Thickness: 200-300 microns, optional
Covering size: 70 – 90 cm (width) x 120 – 150 cm (height),
Reusable (provided appropriate arrangements for decontamination are in place) or biodegradable
• EN ISO 13688
• EN 14126 and partial protection (EN 13034 or EN 14605)
• EN 343 for water and breathability
or alternative equivalent set of standards

If biodegradable,
• EN 13432,
• ASTM D6400
Gown, isolationSingle use, disposable, made of nonwoven material, length mid-calf. Sizes S, M, L, XL May also be reusable, woven, length mid-calf, sizes S, M, L, XL. Critical zones may be more fluid resistant than non-critical zones. Reusable gowns should meet the minimum performance requirements after maximum suggested laundering cycles.• AAMI PB70 (Level 1-3) and ASTM F3352,
• EN 13034 – Type PB [6] (stitched gown), with minimum hydrostatic head of 50 cm H2O
• AAMI PB70 Level 4 and ASTM F3352 or
• ISO 16604 Class 5

or alternative equivalent set of standards
Gown, surgicalSingle use, disposable, nonwoven material, length mid-calf, sterile or non-sterile. Critical zones may be more fluid resistant than non-critical zones.

Or

Single use, woven material, length mid-calf, sterilizable. Critical zones may be more fluid resistant than non-critical zones.
Reusable gowns should meet the minimum performance requirements after maximum suggested laundering cycles.
• AAMI PB70 and ASTM F2407
• EN 13795
• EN 13034 – Type PB [6] (stitched gown), with minimum hydrostatic head of 50 cm H2O

• YY/T 0506
or alternative equivalent set of standards

• EN 556, if sterile
or alternative equivalent set of standards
Alcohol-based hand rubBottle of 100ml & 500ml, at least 80% ethanol or 75% isopropyl alcohol (v/v)• ASTM E2755, or
• EN 1500
or alternative equivalent set of standards

Optional:
• ASTM E1115, or
• ASTM E1174
Bio-hazard bagDisposable autoclavable bag for biohazard waste
Material: High Density Polyethylene (HDPE) or Polypropylene (PP)
Colour: red or yellow
Autoclave ability (temperature resistant up to 121°C)
Printed with a sterilization patch that darkens when subject to steam
Puncture, tear and leak resistant
Leak proof flat bottom seal
Black imprint “Biohazard” and tri-sickle logo according U+2623 on one side
Capacity: Approximately 20L or 50L
Thickness: min 0.038mm (1.5mil)
Sizes:
– width (45 cm), length (50 cm) (±10%)
– width (60 cm), length (82 cm) (±10%)
• Puncture resistant meets ASTM D1709 (dart impact test)
• Tear resistant meets ASTM D1922 or ISO 6383-2
• Temperature Resistance test at 121°C;
Safety boxSAFETY BOX, needles/syringes, 5 L capacity, cardboard for incineration, box-25Biohazard label as per WHO PQS E010/011
SoapLiquid (preferred), powder and bar 
Gloves, cleaningGlove should have long cuffs, reaching well above the wrist, ideally to mid-forearm,
Minimum 280 mm total length
Sizes: S, M, L
Reusable
heavy duty gloves,
High cracking-, puncture- and abrasion resistant
Powder free, Seamless, and entirely waterproof
Made of Nitrile, synthetic rubber (no Latex),
Knit inner lining facilitates slide-in and removal
Cleanable with water and disinfectant (resisting both ethanol solutions 70% and chlorine solutions 0.05% or 500ppm)
Material thickness, at level of the fingers, not less than: 0.38mm
Length not less than: 30cm
Supply co-packed as one left/right pair
EN 388
ANSI 105
EN 374-1, EN 374-2 (at least level 2),
EN 374-4 and EN 374-5
EN 420 + A1
or alternative equivalent set of standards 
Hand drying tissue50 to 100 m roll 
ChlorineNaDCC, granules, 1kg, 65 to 70% + measurement spoon