(195 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 POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
This document is a 510(k) clearance letter from the FDA for "Disposable Powdered Vinyl Synthetic Examination Gloves, White Color." It states that the device is substantially equivalent to legally marketed predicate devices.
The document does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria. The letter is an administrative notice of clearance for marketing, not a detailed technical report of device performance testing.
Therefore, I cannot provide the requested information from the given text.
Here's why the information is missing:
- Device Type: This is a Class I medical device (patient examination glove). For such devices, the 510(k) pathway primarily focuses on demonstrating substantial equivalence to a predicate device, meaning it has the same intended use and technological characteristics, or different characteristics that do not raise new questions of safety and effectiveness.
- Documentation Focus: The provided text is the FDA's clearance letter itself, which summarizes the FDA's decision based on the submitted application. It does not include the detailed technical data, test reports, or study results that would have been submitted by the manufacturer as part of the 510(k) application.
- Nature of Clearance: The 510(k) process for Class I devices often relies on established standards and general controls rather than extensive clinical efficacy studies with specific performance metrics and ground truth establishment as might be required for higher-risk device classifications or AI/software-as-a-medical-device (SaMD) products.
To answer your questions, one would need to review the original 510(k) submission document (K031142) which would contain the performance testing details, if any were required beyond basic physical property tests (e.g., tensile strength, resistance to tearing, barrier integrity).
§ 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.