Yellow knee-length isolation gown with knit cuffs and tie waist, worn over blue scrubs

Protective apparel

Disposable High Risk Isolation Gown

Name: Disposable High Risk Isolation Gown
Brand: Eastwest Medico

AAMI PB70 Level 4 across the whole garment, not only the front. Tape-sealed seams, knit cuffs and knee-length yellow cover for isolation precautions.

AAMI Level 4ASTM F1671FDA Class II 510(k)ASTM F739-12ISO 13485

Material

PP spunbond, PE coated

Colour

Yellow

Sizes

S, M, L, XL – unisex

Basis weight

40 ± 2 g/m²

Sterility

Non-sterile

Shelf life

3 years

Request a quote Download datasheet (PDF)

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

Description

Under ANSI/AAMI PB70 the critical zone of an isolation gown is the entire garment, seams and back included, so a Level 4 claim on this gown describes the whole thing. That is the difference between it and a surgical gown, where only the front panel and lower sleeves have to meet the claimed level and the back may be left unrated.

Non-woven polypropylene spunbond coated with polyethylene at 40 g/m², knee length, with long sleeves, knit cuffs and a tie-neck and tie-waist closure. The seams are heat-sealed and then tape-sealed, which is what allows the barrier level to hold at the stitch line rather than failing there. Presented in yellow with yellow binding tape, the convention that marks out an isolation area at a glance.

The barrier is graded against a microbiological challenge, not water alone: ASTM F1671 with Phi-X174 bacteriophage, no penetration at 13.8 kPa. The same material was tested against 19 chemotherapy substances to ASTM F739-12 with no penetration over the full 480-minute test. FDA cleared as a Class II device under 21 CFR 878.4040 Surgical Apparel, in the surgical isolation gown classification. That places it in the same regulatory category as surgical gowns rather than the Class I exempt category that covers non-surgical isolation gowns. It is not intended for use in the operating room.

Tie-neckKnit cuffTape-sealed seamsKnee lengthChemo testedSingle 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

Levels 1 to 3 are graded against water alone. Level 4 is the only level tested against a microbiological challenge, and CDC states that no correlation can be drawn between the AATCC water resistance tests and ASTM F1671. This gown is Level 4 across the whole garment.

Test results

Property

Method

Result

Water impact

AATCC 42

≤ 1.0 g

Hydrostatic pressure

AATCC 127

> 50 cm H2O

Viral penetration

ASTM F1671

No penetration

Grab tensile strength

ASTM D5034

≥ 30 N (7 lbf)

Seam strength

ASTM D1683

≥ 30 N (7 lbf), critical zone

Trapezoid tear strength

ASTM D5733

≥ 10 N (2.3 lbf), critical zone

Dry linting

ISO 9073-10

Coefficient ≤ 4.0

Flammability

16 CFR 1610

Class 1, does not ignite

Biocompatibility

ISO 10993-5, -10

Non-cytotoxic, non-irritating, non-sensitising

Specification – measurements (cm)

Point

Variance ±

109.2

119.4

129.5

2.5

68.6

71.1

73.7

1.3

20.3

21.6

22.9

1.3

58.4

1.3

25.4

26.7

27.9

1.3

25.4

27.9

30.5

1.3

G (length ea tie @ neck)

30.5

1.3

53.3

58.4

1.3

5.1

0.6

6.3

0.6

7.6

0.6

94.0

101.6

109.2

2.5

94.0

101.6

109.2

2.5

142.2

147.3

152.4

5.1

Reference letters correspond to the dimensional drawing in the datasheet. Extra large is available on request; its measurements are not published.

Product data

Type

Disposable Level 4 high risk isolation gown; tie-neck; knit cuff

Sizes

Small, Medium, Large, Extra Large – all unisex

Compliance

AAMI PB70 Level 4

ASTM F1671 tested

ASTM F739-12 tested

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

Material

Non-woven polypropylene spunbond coated with polyethylene

Colour

Yellow with yellow binding tape

Basis weight

40 ± 2 g/m² (ASTM D3776)

Thickness

0.14 mm average (ASTM D1777)

Sterility

Non-sterile, single use

Latex status

Not made with natural rubber latex

Shelf life

3 years

Storage

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

Manufacturer QMS

ISO 13485, ISO 9001

Chemotherapy substances testedASTM F739-12 · 480 min, no penetration

Substance

Concentration

Carmustine

3.3 mg/mL

Cisplatin

1.0 mg/mL

Cyclophosphamide

20 mg/mL

Cytarabine hydrochloride

100 mg/mL

Dacarbazine

10 mg/mL

Daunorubicin hydrochloride

5 mg/mL

Doxorubicin hydrochloride

2 mg/mL

Etoposide

20 mg/mL

Fluorouracil

50 mg/mL

Vincristine sulfate

1 mg/mL

Methotrexate

25 mg/mL

Mitomycin C

0.5 mg/mL

Mitoxantrone

2.0 mg/mL

Paclitaxel

6 mg/mL

Thiotepa

10 mg/mL

Ifosfamide

50 mg/mL

Oxaliplatin

5 mg/mL

Docetaxel

10 mg/mL

Leucovorin

10 mg/mL

Where chemotherapy drugs are present, gown selection should follow the specific chemicals in use. Review the drug labelling or the safety data sheet to determine an adequate level of protection.

Packaging10 pcs/polybag · 3 polybags/carton · polybags labelled per size

Carton L

Polybag L

Total

34.0

28.0

30.0

33.0

61.0

5.0

30 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 4. The critical zone of an isolation gown is the entire garment, seams and back included; only cuffs, hems and bindings are excluded.

Viral penetration

ASTM F1671 with Phi-X174 bacteriophage; no penetration at 13.8 kPa.

Chemotherapy testing

ASTM F739-12; no penetration detected across 19 substances during the 480-minute standardised test duration.

Regulatory clearance

FDA 510(k) cleared as a Class II device under 21 CFR 878.4040 Surgical Apparel, in the surgical isolation gown classification. Not intended for use in the operating room.

Biocompatibility and flammability

ISO 10993-5 and ISO 10993-10: non-cytotoxic, non-irritating, non-sensitising. 16 CFR 1610 Class 1.

Manufacturer QMS

ISO 13485, ISO 9001.

Latex

Not made with natural rubber latex.

AAMI Level 4ASTM F1671FDA Class II 510(k)ASTM F739-12ISO 13485

Ordering

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

Item

Product number

Pack

Disposable High Risk Isolation Gown, small

EW-GWN-HR-S

30 pcs

Disposable High Risk Isolation Gown, medium

EW-GWN-HR-M

30 pcs

Disposable High Risk Isolation Gown, large

EW-GWN-HR-L

30 pcs

Disposable High Risk Isolation Gown, extra large (on request)

EW-GWN-HR-XL

30 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) clearanceASTM F1671 viral penetration reportASTM F739-12 chemotherapy reportAAMI PB70 barrier reportDimensional drawingISO certificates (manufacturer)

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