(49 days)
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGERS TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WHITE COLOR
The provided text is a 510(k) summary letter from the FDA to Synmertex Company Limited regarding their Disposable Powder Free Vinyl Synthetic Examination Gloves. This letter does not describe acceptance criteria for a device, nor does it detail a study proving device performance based on such criteria. Instead, it is an FDA clearance letter, indicating that the device has been determined to be substantially equivalent to a legally marketed predicate device.
Therefore, I cannot provide the requested information from the given text.
The document discusses:
- Device Name: Disposable Powder Free Vinyl Synthetic Examination Gloves, White Color
- Regulation Number & Product Code: 880.6250, LYZ (Patient Examination Glove, Class I)
- Indications For Use: "A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner."
- FDA Clearance: The letter states the device is "substantially equivalent" to predicate devices.
This type of FDA letter confirms market clearance, but it does not include detailed performance studies, acceptance criteria, or ground truth methodologies that would be typical for many medical devices, especially those involving AI or more complex functionalities. For examination gloves, performance is usually assessed against established ASTM (American Society for Testing and Materials) standards (e.g., for barrier integrity, tensile strength), but these details are not present in this FDA clearance letter.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.