DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)16 General PurposeSurgical DrapeA sterile protectivecovering made ofnatural or syntheticmaterials, or bothTo isolate a site of surgical incision or a surgicalfield from contamination (e.g., microbial,substance) in various clinical settings (e.g. in anoperating room or catheterization laboratory). Thedevice may also be used to protect a patient fromheat/ flame during a surgical procedure. This is areusable or single use device.MEDICAL DEVICE(If the product/ device did notcontain Iodine or containedIodine < 2%)DRUG(If the product/ devicecontained Iodine ≥ 2%)17 Wart Cryogenic KitA refrigerant madefrom dimethyl etherand propane.To freeze superficial skin lesions (e.g. warts) fortheir destruction and removal.MEDICAL DEVICE18 Pressure-ulcerTopical DressingA solution or emulsiondesigned to be appliedto dermal pressuresores.To prevent and treat pressure/ decubitus ulcersand lower extremity ulcers. It is intended primarilyto create a barrier between the skin lesion(s) andthe external environment to promote protection andhealing.MEDICAL DEVICE19 Hand Sanitizer For general hand hygiene COSMETICNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 49