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AAMI Level 4 disposable laboratory gown worn with hair cap and shoe covers
Protective apparel

Disposable AAMI Level 4 Laboratory Gown

Highest fluid and microbial barrier protection – AAMI PB70 Level 4 and ASTM F3352, chemotherapy tested to ASTM F739-12.

AAMI Level 4ASTM F3352ASTM F739-12FDA 510(K)MDR 2017/745
Material
Non-woven polyethylene
Colour
White
Sizes
S, M, L – unisex
Sterility
Non-sterile
Latex status
Not made with natural rubber latex
Shelf life
3 years
Request a quoteDownload datasheet (PDF)

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

Description

The top barrier tier, and the one gown that also covers cytotoxic handling. AAMI PB70 Level 4 is the highest fluid and microbial barrier classification, tested against bloodborne pathogens in the critical zone, so it holds for long, fluid-intensive procedures.

The same material was tested against 19 chemotherapy substances to ASTM F739-12 with no penetration over the full 480-minute test, which means oncology preparation does not need a separate gown line.

Non-woven polyethylene, knee length, with knit cuffs and bound seams reinforced with garment fabric to limit particle penetration at the stitch line. FDA 510(k) cleared and a Class I medical device under MDR 2017/745.

Tie-neckKnit cuffBound 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.

Specification – measurements (cm)
Point
S
M
L
Variance ±
A
43.00
47.00
51.00
1.00
B
27.00
28.00
29.00
0.50
C
8.00
8.50
9.00
0.50
D
23.00
23.00
23.00
0.50
E
10.00
10.50
11.00
0.50
F
10.00
11.00
12.00
0.50
G (length ea tie @ neck)
12.00
12.00
12.00
0.50
H
21.00
21.00
23.00
0.50
I
2.00
2.00
2.00
0.25
J
2.50
2.50
2.50
0.25
K
3.00
3.00
3.00
0.25
L
37.00
40.00
43.00
1.00
M
37.00
40.00
43.00
1.00
N
56.00
58.00
60.00
2.00
Reference letters correspond to the dimensional drawing in the datasheet.
Product data
Type
Disposable Level 4 laboratory gown; tie-neck; knit cuff
Sizes
Small, Medium, Large – all unisex
Compliance
ASTM F739-12 tested
AAMI Level 4
FDA 510(k)
Medical device Class 1 (MDR 2017/745)
Material
Non-woven polyethylene
Colour
White
Sterility
Non-sterile
Latex status
Not made with natural rubber latex
Shelf life
3 years
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
Packaging10 pcs/polybag · 3 polybags/carton
Carton L
W
H
Polybag L
W
H
Total
44.0
28.0
27.0
33.0
61.0
5.0
30 pcs
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 and ASTM F3352 – highest fluid and microbial barrier protection.
Chemotherapy testing
ASTM F739-12; no penetration detected across 19 substances during the 480-minute standardised test duration.
Regulatory clearance
FDA 510(k) cleared; Medical device, Class I, in accordance with MDR 2017/745.
Manufacturer QMS
ISO 13485, ISO 9001.
Latex
Not made with natural rubber latex.
AAMI Level 4ASTM F3352ASTM F739-12FDA 510(K)MDR 2017/745
Ordering

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

Item
Product number
Pack
Disposable AAMI Level 4 Laboratory Gown, small
EW-GWN-L4-S
30 pcs
Disposable AAMI Level 4 Laboratory Gown, medium
EW-GWN-L4-M
30 pcs
Disposable AAMI Level 4 Laboratory Gown, large
EW-GWN-L4-L
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 F739-12 test reportAAMI PB70 barrier reportDimensional drawingISO certificates (manufacturer)
Request documentationSigned sets issued for tender submission, normally within two working days.

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