(39 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
The provided text is a 510(k) premarket notification approval letter for "Disposable Powder Free Vinyl Synthetic Exam Gloves." This type of document from the FDA relates to the regulatory clearance of a medical device based on substantial equivalence to a predicate device, rather than a study proving the device meets specific performance acceptance criteria in the way an AI/ML algorithm would.
Therefore, the information requested in your prompt (acceptance criteria table, sample sizes, expert qualifications, MRMC study, etc.) is not applicable to this document.
Here's why and what information can be extracted:
- Acceptance Criteria & Device Performance: The approval is based on "substantial equivalence" to a legally marketed predicate device. This means the FDA determined the new device is as safe and effective as a previously cleared device. There aren't explicit performance metrics or acceptance criteria stated in a quantitative table for this type of device in this document. Instead, the device is expected to meet general controls and standards applicable to patient examination gloves.
- Study Details (Sample Size, Ground Truth, Experts, Adjudication, MRMC, Standalone): These concepts are relevant to the validation of AI/ML algorithms, clinical trials, or performance studies that assess diagnostic accuracy, sensitivity, specificity, etc. A premarket notification for disposable exam gloves does not typically involve such studies described in the context you've provided. The "study" for this device would have involved demonstrating compliance with relevant standards (e.g., for barrier integrity, biocompatibility, dimensions, strength), commonly through laboratory testing, not clinical trials with human readers or AI.
- Training Set & Ground Truth for Training: Again, not applicable. This device is a physical product (gloves), not an AI algorithm requiring a training set.
In summary, the provided document does not contain the information needed to answer your questions because it concerns the regulatory clearance of a physical medical device (gloves) under the 510(k) pathway, which is distinct from the validation process of an AI/ML diagnostic or assistive device.
§ 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.