Extra-long sleeve covers with thumb loops, non-sterile

In preparation. This article belongs to the new ProSafe cleanroom line and is not yet available. All technical figures are target specifications for series production, not product commitments. Test reports, conformity documents and sterilisation validations will be supplied with the release of the series.

550 mm sleeve covers in microporous laminate, aseptically folded. The thumb loop holds the sleeve cover under the glove; openings and elastic are set on the reference sample.

Technical details

Article code	P021
Delivery condition	non-sterile
Material	Microporous PP/PE laminate, 60 g/m² (tolerance ±2 g/m²)
Dimensions	Length 550 mm
Sizes	One size
Pack size	10 pairs per inner bag, 1 inner per outer bag; 10 outer bags per carton = 100 pairs; carton 32 × 28 × 37 cm
Target environment	ISO Class 4 and 5 cleanrooms and controlled areas; GMP use subject to the operator's own assessment
Supply	on request after release of the series, quote with price and pack size

Features

Extra long, 550 mm
Thumb loop
Aseptically folded
Non-sterile

Target specification (design targets)

Target values for series production. They describe what we design material, construction and testing for and are not a commitment for the delivered article. Lot test reports will be supplied with the series.

Basis weight	60 g/m², tolerance ±2 g/m²
Hydrostatic head	minimum 100 mm H₂O
Particle shedding (Helmke drum)	Category I to IEST-RP-CC003
Surface resistivity	typically 10⁷ to 10¹⁰ Ω
Chemical permeation (ASTM F739)	Carmustine 30 min, thiotepa 60 min; cisplatin, cyclophosphamide, doxorubicin, etoposide, fluorouracil, methotrexate, paclitaxel over 480 min (ASTM F739, design target)
Shelf life	5 years from manufacture
Storage	Dry and cool below 40 °C, away from direct sunlight

Standards framework

PPE Regulation (EU) 2016/425 (PB [6], planned)
EN 14325 (material tests)
IEST-RP-CC003 (particle shedding)

Notes on use

Sleeve covers are put on after the coverall and before the gloves; the glove goes over the sleeve cover. Replace after contact with liquid or when changing gloves. Single-use product.

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