Blue surgical gown with white reinforced front panel and sleeves, shown inside out over green scrubs

Protective apparel

Reinforced Surgical Gown, AAMI Level 3

Name: Reinforced Surgical Gown, AAMI Level 3
Brand: Eastwest Medico

AAMI PB70 Level 3 across the critical zone, with a poly-reinforced front panel and sleeves that passed ASTM F1671 viral penetration testing.

AAMI Level 3ASTM F1671FDA Class II 510(k)ISO 13485

Material

SMS polypropylene

Colour

Blue with white panel

Sizes

L, XL – unisex

Basis weight

47 g/m²

Sterility

Non-sterile

Shelf life

5 years

Request a quote Download datasheet (PDF)

Supplied on tender, framework agreement and humanitarian programme terms. Sample cartons available for evaluation.

Description

On a surgical gown the critical zone under ANSI/AAMI PB70 is the front panel from chest to knee and the sleeves from cuff to above the elbow. That is narrower than on an isolation gown, where the critical zone is the entire garment, and it means the back of a surgical gown may be non-protective. Here the critical zone is formed by the poly-reinforced SPP and PE laminate over the front panel and sleeves, and it is that zone the Level 3 claim describes.

The body is 47 g/m² non-woven polypropylene SMS, spunbond, meltblown and spunbond, with the laminate reinforcement bonded over the critical zone. Full-length sleeves with 8 cm knit cuffs, a hook-and-loop neck fastening, a waist tie and a back wrap closure. The body is blue and the reinforcement panel white, so the reinforced area can be seen at a glance. Supplied non-sterile and individually bagged, in Large and X-Large.

Independently tested by SGS. Hydrostatic pressure reached 145.0 cm H2O against the 50 cm that Level 3 requires, with zero water impact penetration. The reinforced areas and their seams were additionally tested to ASTM F1671, the viral penetration method used for Level 4, at the chest and both forearms, with no penetration of Phi-X174 in any of the three specimens. That is a result on the reinforced zone rather than a Level 4 classification for the gown. FDA cleared as a Class II device under 21 CFR 878.4040 Surgical Apparel, and intended for use in the operating room.

Poly-reinforced frontReinforced sleevesKnit cuffHook-and-loop neckBack wrapSingle use

Technical data

Data as declared by the manufacturer and verified in our own quality review. Full test reports available on request.

Barrier classificationANSI/AAMI PB70

Level

Test method

Challenge

Pass requirement

AATCC 42

Water

≤ 4.5 g

AATCC 42 and 127

Water

≤ 1.0 g and ≥ 20 cm H2O

AATCC 42 and 127

Water

≤ 1.0 g and ≥ 50 cm H2O

ASTM F1671 viral penetration

Phi-X174

No penetration at 13.8 kPa

The critical zone of a surgical gown is the front panel and the sleeves, not the whole garment. This gown is Level 3 across that zone, tested at 145.0 cm H2O hydrostatic pressure, 2.9 times the Level 3 requirement, with zero water impact penetration.

Test results

Property

Method

Result

Hydrostatic pressure

AATCC 127

145.0 cm H2O (Level 3 requires ≥ 50)

Water impact

AATCC 42

0 g (Level 3 requires ≤ 1.0)

Viral penetration

ASTM F1671

No penetration, < 1 PFU

Grab breaking strength

ASTM D5034

132.30 N warp, 139.16 N filling

Seam strength

ASTM D1683

98.0 N

Trapezoid tear strength

ASTM D5733

33.32 N warp, 36.26 N filling

Dry linting

ISO 9073-10

Log10 2.89

Flammability

16 CFR 1610

Class 1, did not ignite

Performance testing conducted by SGS on the cleared model range. Testing was performed on EO-sterilised samples; the non-sterile product is identical in material and construction.

Specification – measurements (cm)

Point

Tolerance ±

A Overall length, front

132

137

B Circumference, hem

137

142

C Armhole depth

1.5

D Shoulder width

E Circumference, upper body

F Body width, flat

G Sleeve length, neck point to cuff

H Cuff length

1.5

I Neck / collar, minimum

8.5

min

O Waist tie length

P Back tie length

a Reinforcement panel, width at top

1.5

b Reinforcement panel, length

105

c Reinforcement panel, width at bottom

Keyed to the manufacturer's measurement drawing. The letter codes are the manufacturer's; the descriptive labels are our reading of the drawing and are not confirmed in writing by the manufacturer.

Product data

Type

Non-sterile reinforced surgical gown, AAMI Level 3

Sizes

Large, X-Large – both unisex

Compliance

AAMI PB70 Level 3

ASTM F1671 tested

FDA 510(k), Class II under 21 CFR 878.4040 Surgical Apparel

Material

Non-woven polypropylene SMS (spunbond, meltblown, spunbond)

Reinforcement

SPP and PE laminate over the front panel and sleeves

Colour

Blue body with white reinforcement panel

Basis weight

47 g/m² (SMS base fabric)

Closure

Hook-and-loop neck fastening, waist tie, back wrap

Cuff

Knit cuff, 8 cm

Sterility

Non-sterile, single use

Latex status

Latex-free, not made with natural rubber latex

Shelf life

5 years

Storage

+5 °C to +40 °C, RH ≤ 70%, keep away from direct sunlight

Manufacturer QMS

ISO 13485:2016

Packaging1 pc/polybag · 40 polybags/carton · individually bagged, labelled per size

Size

Carton L

Net kg

Gross kg

Total

Large

56.0

40.0

36.0

6.50

7.60

40 pcs

X-Large

56.0

40.0

36.0

6.83

7.95

40 pcs

Instructions for use are supplied with each carton.

Quality management

Every batch is inspected by our own team in Asia and independently verified by SGS or TÜV before shipment.

Barrier performance

AAMI PB70 Level 3 across the critical zone. On a surgical gown that zone is the front panel from chest to knee and the sleeves from cuff to above the elbow; the back may be non-protective.

Test performance

AATCC 127 hydrostatic pressure 145.0 cm H2O against the 50 cm Level 3 requirement. AATCC 42 water impact 0 g against a limit of 1.0 g.

Viral penetration

The poly-reinforced areas and their seams were tested to ASTM F1671 at the chest and both forearms, with no penetration of Phi-X174 detected in any of three specimens. That is a result on the reinforced zone, not a Level 4 classification for the gown.

Regulatory clearance

FDA 510(k) cleared as a Class II device under 21 CFR 878.4040 Surgical Apparel. Intended for use in the operating room.

Flammability

16 CFR 1610 Class 1, did not ignite.

Testing

Performance testing conducted by SGS on EO-sterilised samples; the non-sterile product is identical in material and construction.

Manufacturer QMS

ISO 13485:2016.

Latex

Latex-free, not made with natural rubber latex.

AAMI Level 3ASTM F1671FDA Class II 510(k)ISO 13485

Ordering

Product numbers for reordering and framework call-offs. Private-label and custom packaging available on volume.

Item

Product number

Pack

Reinforced Surgical Gown, AAMI Level 3, large

EW-GWN-SR-L

40 pcs

Reinforced Surgical Gown, AAMI Level 3, extra large

EW-GWN-SR-XL

40 pcs

Documents

The technical datasheet and declaration of conformity are available to download. All further documentation is issued on request, signed and current, for tender submission.

Available on request

FDA 510(k) clearanceAAMI PB70 barrier reportASTM F1671 viral penetration reportDimensional drawingISO certificates (manufacturer)

Request documentationSigned sets issued for tender submission, normally within two working days.