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Polyisoprene Surgical Gloves

Best Performance Non-latex Synthetic

Keywords:

Medical gloves

Category:

Non-latex gloves

Consultation

Medispo® PI Features:

Latex-free: Super soft polyisoprene formulation that is also tough to protect you and patients from pathogens. Exceeds all strength requirements according to USA and EU International standards.

Skin-friendly formulation: Our unique chlorine-free formulation production processes combined with the absence of chemical accelerators known to cause allergic responses mean skin irritations are minimised or eliminated. Tested according to ISO EN 10993.

Easy donning: Skin friendly polymer coated for easy donning even with damp hands saving you time.

Consistent calibrated grip: The outer surface of Medispo surgical gloves are specially treated to provide a consistent grip. The grip is monitored and controlled during production and each lot must pass stringent internal grip controls before being released.

Complies with the following Standards and Regulations:

Quality: ISO 9001, EN ISO 13485
Compliance EU: CE Mark, MDR, EN 455 1-4, EN ISO 374 1-5 Compliance USA: 510K, ASTM D3577
Environment: EN ISO 14001:2015

Product Information:

Product Name / Description	Medispo® Polyisoprene, Sterile, Super-Soft, Ergonomic Design, EUSA Mould
Latex / Latex-free/ material	Latex-free, Polyisoprene
Color	White Cream
Cuff type	Beaded cuff
Accelerators used	ZDEC; CAS No.14324-55-1
Accelerators NOT used	Does not contain: Diphenylguanidine (DPG), Thiaurams, Mercaptobenzothiazoles (MBT), P-phenylenediamine (PPD), Zinc dibutylthiocarbamate (ZDBC), Dialkyl thioureas (DTU)
Texture / Grip	Micro textured, calibrated grip, medium
Sterile / Non-Sterile / Method	Sterile, E-Beam
Powder / Powder-free	Powder-free
Design	Anatomical, forward thumb ball, hand specific
AQL value	0.65 (Typically 0.30 – 0.45)
International Product Standards	EN 455 1-4, EN ISO 374 1-5: 2016, EN ISO 21420: 2019, ASTM D3577, ASTM D6978, ASTM F739, ISO 10993, AS/NZS 4179, ISO 10282, JIS T9107
Quality / Environmental Standards	ISO 9001, ISO 13485: 2016, ISO 14001
Shelf Life	3 Years
Compliance to regulations	EU MDR 2017/745, USA 510k, MDSAP
Notified body / Test Laboratories	BSI, SATRA, ARDL, TUV, SGS
PPE compliance / Type	PPE Regulation (EU) 2016/425, Type B
Biological Evaluation	EN 10993, Primary Skin Irritation Test, Dermal Sensitization Assay, Cytotoxicity Test
Additional tests	Viral Penetration PPE Compliance (ASTM F1671), Chemotherapy Drugs (ASTM D6978), Chemical Residuals test data available upon request

Product Specifacation

Item No.	MPIG55	MPIG60	MPIG65	MPIG70	MPIG75	MPIG80	MPIG85	MPIG90
Size	5.5	6	6.5	7	7.5	8	8.5	9
Length(±5mm)	290	290	290	290	290	290	290	300
Thickness(±0.03mm)	Fingertip: 0.23 Palm: 0.21 Cuff: 0.16

Packing Information

Pouch material and configuration options	Full-length or square half-fold peel pouch or Paper-Paper packaging
Packing Quantity	Pouch	Inner box	Shipping Carton
Packing Quantity	1pair/pouch	50pairs/box	200pairs or 400pairs/carton

European Representation

EC Rep & Registration No.	HBM Medical, Coliemore House, 3 Coliemore Road, Dalkey, Co Dublin, Ireland: 653382
EC Rep Contact Details	INFO@4SHBM.COM, Telephone +353 1 582 2308, www.4shbm.com
Manufacturer	Guilin HBM Health Protections Inc
	Address: No.1-2, Shujing East Road, Economic and Technological Development Area, Guilin, China
	Email: guilinhbm@hbmchina.com
	Web: www.hbmchina.com

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Guilin Hengbao Health Protection Co., Ltd.