Is medical sterile drape classified as Class I or Class II?

Most medical sterile drapes are classified as Class II medical devices, while a few that are intended solely for general hygiene protection and have no specific medical therapeutic function are categorized as Class I medical devices. Class II products must strictly comply with manufacturing standards and regulatory requirements, and users should pay attention to the product's qualifications. If skin allergies, infections, or other issues occur during use, medical advice should be sought promptly.

Class I medical sterile drapes are primarily used for daily hygiene protection, such as being placed under patients during routine care to prevent cross-contamination. They have relatively simple manufacturing processes, lower sterility requirements, do not require rigorous clinical validation, and can be manufactured and sold after registration and filing.

Class II medical sterile drapes are used in clinical settings with specific medical needs, such as surgery, wound care, and postpartum care. These products must meet higher sterility standards and effectively block the transmission of pathogens. Their production requires strict regulatory review, and the products must undergo clinical performance evaluation to ensure safety and effectiveness.

Prior to using a medical sterile drape, check that the packaging is intact and not damaged or expired. Once opened, use promptly to avoid prolonged exposure and contamination. Place the drape correctly according to need, and dispose of it properly as medical waste after use—do not discard it casually.