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