What class of medical device is a sterile medical drape?
Dec 03, 2025
Source: Cainiu Health
Dr. Li Feng
Introduction
Sterile medical drapes are classified as Class II medical devices, for which safety and effectiveness need to be controlled, meeting the management requirements for moderate-risk categories. If abnormal conditions such as skin allergy or infection occur after use, medical attention is recommended promptly. According to the classification rules for medical devices, devices provided in a sterile form are classified no lower than Class II.
Sterile medical drapes are classified as Class II medical devices, which require controlled safety and effectiveness, meeting the management requirements for moderate-risk categories. If abnormal conditions such as skin allergies or infections occur after use, prompt medical attention is recommended.
According to medical device classification rules, medical devices provided in sterile form are classified as no less than Class II. Sterile medical drapes undergo ethylene oxide sterilization to achieve zero fungi and zero bacteria standards and require strict control throughout production and distribution; therefore, they are categorized as Class II.
As a Class II medical device, it must obtain registration approval from the National Medical Products Administration before market release. The product must meet medical hygiene material standards and have individually sealed packaging, be free of sterilization residues, and contain no migratable fluorescent agents, ensuring safe usage.
Prior to use, check the integrity of the packaging. After opening, use promptly to avoid contamination. Replace every 2–4 hours depending on the amount of secretion. Individuals with sensitive skin should prioritize products from reputable brands. Store in a dry, well-ventilated area away from contamination sources to ensure effectiveness and safety during use.
