Search Results

The devices are intended for use as a barrier that is used as an accessory to oral or rectal for digital thermometers. These sheaths are non-sterile and are intended for single patient use only.

The disposable thermometer sheaths are plastic coverings used for either oral or rectal for digital thermometer. The products and its packaging are non-sterile and latex-free.

The document provided is a 510(k) summary for the GOOD MEDY Disposable Thermometer Sheaths. It does not contain information about acceptance criteria or a study proving the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information. The document only states:

• The new devices are substantially equivalent to the predicate devices: Sanitherm Oral Disposable Thermometer Sheaths, K983406.
• The intended use of the two devices is the same, and the overall dimensions are similar.
• The two devices also had passed the biocompatibility test by ISO10993, same non-sterile and latex-free.

No specific performance metrics, test results, or study details are provided beyond the biocompatibility test.

Ask a specific question about this device