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Polyisoprene Double Gloving Surgical Gloves

Easy-don Double Gloving Double Layer Protection

Keywords:

Medical gloves

Category:

Non-latex gloves

Consultation

Medispo® PI Double Gloving Features:

Perforation detection: Medispo PI Double Gloving There are two types of gloves inside the double layer glove packaging: one pair of Medispo PI Sensitive outer gloves and one pair of ½ a size larger PI blue under gloves. Designed to be comfortable and reliable for any type of surgical procedure.

Protection: Computer control and predictive quality analytics (AI) mean that each glove undergoes rigorous quality controls before release. In addition, each glove is 100% air leaked and visually inspected.

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
Environment: EN ISO 14001:2015

Product Information:

Product Name / Description	Medispo® POLYISOPRENE DOUBLE GLOVING, Sterile, Hand Specific
Latex / Latex-free/ material	Latex-free, Polyisoprene
Color	White outer PI glove and blue under PI glove
Cuff type	Beaded cuff
Accelerators used	ZDEC (DPG Free)
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
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	SATRA, ARDL, BSI
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	Chemical Residue

Product Specifacation

Item No.	MPSD55	MPSD60	MPSD65	MPSD70	MPSD75	MPSD80	MPSD85
Size	5.5#+6.0#	6.0#+6.5#	6.5#+7.0#	7.0#+7.5#	7.5#+8.0#	8.0#+8.5#	8.5#+9.0#
Length(±5mm)	290	290	290	290	290	290	300
Thickness(±0.03mm)	Fingertip: 0.21 Palm: 0.20 Cuff: 0.15

Packing Information

Pouch material	Long plastic peel pouch
Packing Quantity	Pouch	Inner box	Shipping Carton
Packing Quantity	2pair/pouch	50pairs(25pouches)/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.