What class of medical device is a disposable vaginal speculum?

Disposable vaginal speculums are Class II medical devices used for vaginal dilation. Specific details are as follows:

A disposable vaginal speculum is a duck-bill-shaped instrument composed of two blades (upper and lower) and a handle, primarily used for routine gynecological examinations and surgical procedures. Certain gynecological conditions require examination of the patient's vagina and cervix. Since the vagina is a tubular organ, its internal condition is often difficult to assess through routine gynecological examination alone. In such cases, a disposable vaginal speculum can be used to separate the vaginal walls, allowing the physician to observe the vaginal mucosa, vaginal discharge, and cervix. When using a disposable vaginal speculum, care should be taken to avoid forceful manipulation, which could cause injury to the vaginal opening or internal vaginal tissues.

However, it should be noted that some women may purchase disposable vaginal speculums themselves and attempt self-examination at home. Improper technique or overly aggressive handling during self-use may lead to damage of the vaginal mucosa. Additionally, home environments cannot guarantee the sterile conditions of clinical settings, making aseptic procedures difficult to maintain. Therefore, it is generally not recommended to use medical-grade disposable vaginal speculums for self-examination at home.