PRODUCT INFORMATION/DATA SHEET

PRODUCT: POLYFIELD DRESSING AID-WITH POWDER FREE GLOVES,STERILE

With Yellow Poly Bag

SIZE(S) & CODE Ref(s).: SMALL - 6010PF MEDIUM-6011PF, LARGE-6012PF

With White Poly Bag

SMALL-6020PF, MEDIUM-6021PF, LARGE-6022PF

PRIMARY USE: WOUND CARE MANAGEMENT PRODUCT, FOR USE IN STERILE

PROCEDURES AND WOUND CARE IN HOSPITALS, COMMUNITY

CARE AND OTHER AREAS

MATERIAL: Integral, Dipped Natural Latex Rubber Gloves (1 Pair)

Powder Free, textured surface and rolled (beaded) cuff. Disposable Poly Bag

(White or Yellow), (Both in 100% Low Density Polythene Film) and Laminated Sheet

DIMENSIONS: Minimum Thickness : 0.15 mm at Palm

Minimum Length of Gloves : 240 mm

Palm Width of Gloves : SMALL 80 mm + 10 mm

MEDIUM 95 mm + 10 mm

LARGE 110 mm + 10 mm

Poly Dispo Bag - 27 x 46 cms. (10.5” x 18”)

Green Polyfield Sheet - 50 x 45 cms. (19.5” x 17.5”)

QUALITY GLOVES:

Sampling Levels A.Q.L Standards Met

Freedom from Holes G.1 1.5 Meets BS.EN455 Parts 1&2

Physical Properties S.2 4.0 British/Europea Standards

Dimensions & Strength S.2 4.0 for Medical Gloves

Residual Extractable Protein (range) <40 mcg/g

Residual Accelerator Content (range) 0.15%

No Known standard exists for the Dispo Poly Bag or the Green Polyfield Sheet.

Sterilised by Ionisation

PACKING & LABELLING Each pack consists of 1 pair of Gloves, 1 Poly Bag and 1 Green

Polyfield Sheet in a sealed paper pouch, 50 pouches per Dispenser

4 Dispensers per Outer Carton (200 packs). All pouches, Dispensers and

Outer Cartons marked with Product name, Premier Logo, Size,

Code Ref., Lot Number, Expiry date and CE Mark. Each Outer Carton

also bears an Irradiation label, and all packing bear marking for Single

use in accordance with current regulations.

SPECIAL STORAGE CONDITIONS: KEEP IN A COOL DRY PLACE AWAY FROM HEAT AND

DIRECT SUNLIGHT

RISK ANALYSIS: Residual protein & Residual accelerator levels have been reduced to very

low level. Highly sensitised persons may develop Type I allergic skin

contact reaction and Type IV delayed allergic reaction to these gloves but

this is less likely to occur than from contact with Powdered Gloves.

Approximately only 2% of the general population have a CU sensitivity.

Therefore, low risk category.

No known risk exists for the balance items in this pack, but care should

be taken with the Poly Bag to avoid the risk of asphyxiation with infants.

Pack remains sterile until torn or opened.

SHELF LIFE: 3 Years - if stored as recommended above

CLASSIFICATION: CLASS IIa - Medical Devices Directive 93/42/EEC

Dated: Jan 2003

Issue No.: 2

AMENDMENT RECORD: Glove Dimensions Adjusted Jan 2003