(56 days)
A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
Syntex Powder-Free Polymer-Coated Nitrile Examination Gloves
This document is a 510(k) premarket notification letter from the FDA regarding "Syntex Powder-Free Polymer-Coated Nitrile Examination Gloves." It confirms the device's substantial equivalence to legally marketed predicate devices and permits its marketing.
The request for "acceptance criteria and the study that proves the device meets the acceptance criteria" is not applicable to this document. This letter is an FDA clearance, not a study report. It does not contain information about:
- A table of acceptance criteria and the reported device performance: This document does not detail specific performance criteria or test results.
- Sample size used for the test set and the data provenance: No test set details are provided.
- Number of experts used to establish the ground truth...: This is irrelevant to an FDA clearance letter for examination gloves.
- Adjudication method: Not applicable.
- Multi reader multi case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable, as this is a physical medical device (gloves), not an AI algorithm.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document indicates that the device is "substantially equivalent" to legally marketed predicate devices. For examination gloves, this typically means demonstrating performance parameters (like barrier integrity, tensile strength, freedom from pinholes) that meet recognized consensus standards (e.g., ASTM standards) to be as safe and effective as existing gloves on the market. However, the details of these tests and their results are not present in this specific FDA clearance letter. Such information would be found in the 510(k) submission itself, not in the 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.