Orchid is our own OEM brand manufactured by our accredited and certified partners. The product has the certifications as a MEDICAL DEVICE, not simply as PPE. Orchid Global is a single product that possess the key certifications for both Europe and North America for optimal distribution. Our gloves are only made from Pure, natural Nitrile (NBR), it is unlike many others that eventually state they are a "Nitrile/Mix" or "Synthetic Nitrile". Do not be confused between the quality, acceptability to your clients and eventually the price point of these fundamentally different products to our own. Details: Powder Free Medical Nitrile (NBR) Examination Gloves, Non-Sterile 9 inch, Blue, Beaded Cuff and Textured Fingertips Standards and certifications: CE, ISO-9001, ISO-13485, Chemotherapy Drug Approval; EU - EN455 (Medical Device), EN374 (Examination and PPE), EU Medical use Approval; US - FDA510K, Medical Grading certifications: ASTM-D6319, ASTM-D6124, ASTM-D6978-5 Product Options: Textured Finger Tips or Textured Palm and Fingers. Shipping options: EXW, FOB, CIF * Other sizes, colours and packaging available upon enquiry More information and SOP are available on our website catalogue.