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

Nov 28, 2025 Source: Cainiu Health

Dr. Li Feng

Introduction

Class II sterile medical pads are used in specific medical scenarios such as surgery, wound care, and postpartum care, and must have a high level of sterility to prevent the transmission of pathogens. Their production requires strict review, and the products must undergo clinical performance evaluation to ensure safe and effective use. The packaging will indicate the medical device registration number.

Generally, medical sterile drapes are classified as Class II medical devices, while a few intended solely for basic hygiene protection are categorized as Class I medical devices. In case of any abnormalities, it is recommended to seek medical attention promptly. The detailed analysis is as follows:

Class II medical sterile drapes are used in specific medical settings such as surgery, wound care, and postpartum care. They require a high level of sterility to prevent the transmission of pathogens. Their manufacturing process must undergo strict review, and the products must undergo clinical performance evaluation to ensure safety and effectiveness. These products will also bear a medical device registration number on the packaging.

Class I medical sterile drapes are primarily used for daily hygiene protection, such as laying down during routine care to prevent cross-contamination. Their production process is relatively simple, with lower sterility requirements. They do not require rigorous clinical validation and can be manufactured and sold after simple filing. However, their applicable scenarios and protective efficacy are limited.

Prior to use, check that the packaging is intact, undamaged, and not expired. Use immediately after opening to avoid prolonged exposure that may lead to contamination. Purchase from正规 channels and avoid using products of unknown origin to ensure safe usage.

View All

What class of medical device is a sterile medical drape?

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.

View Full Answer

What is a sterile medical drape?

Sterile medical drapes are medical protective consumables that have undergone strict sterilization. They are primarily used in medical procedures to isolate contaminants, protect wounds, and maintain a sterile environment, and are widely applied in both clinical and home care settings with well-established safety profiles. Commonly used in surgical draping, wound care, and gynecological examinations, these drapes prevent contact between bodily fluids, secretions, and the surrounding environment, helping to keep the local area dry and clean.