Manufacturer ISO 9001& ISO 13485 accredited
-	Quality assurance programs at all stages of production to ensure against defects
-	Documentation available on request

	Lot numbers allocated to every box of gloves
-	Allows for traceability and accountability for each production batch

	EXCEED ALL requirements of:
-	FDA 510K (USA pre market notification for Class 1 medical devices)
-	CE Marking (compliance with European Standards)

	COMPLY WITH ALL requirements of:
-	US Code of Federal Regulations, Title 21, Parts 170-199, Section 177.2600
	Documentation available on request

	BEEN NOTIFIED on the New Zealand MEDSAFE  database for Medical Devices:
-	As required by the Medicines Regulations 2003