(84 days)
A 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.
Chlorinated, Polymer-coated Powder-free Latex Patient Examination Glove, with extractable protein content labeling claim (50 microgram per gram of glove or less)
This document is a 510(k) premarket notification clearance letter for a medical device, specifically a "Chlorinated, Polymer-coated Powder-free Latex Patient Examination Glove." The letter indicates that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.
However, this type of document (a 510(k) clearance letter) does not typically contain detailed information about acceptance criteria or specific study results in the way you've requested for performance validation. Instead, it confirms that the manufacturer has submitted sufficient information to demonstrate substantial equivalence to a predicate device, often based on adherence to recognized standards and general safety/performance considerations.
Therefore, I cannot extract the specific information you are asking for (acceptance criteria table, sample sizes for test/training, expert details, adjudication methods, MRMC study results, standalone performance, or detailed ground truth methods) directly from this document. These details would typically be found in the submission's technical documentation, test reports, or clinical study summaries, which are not part of this clearance letter.
The clearance letter focuses on:
- Device Name: Chlorinated, Polymer-coated Powder-free Latex Patient Examination Glove with Extractable Protein Content Labeling Claim (50 Microgram per gram of Glove of Less)
- Regulation Number/Name: 21 CFR 880.6250, Patient Examination Glove, Class I
- Indication for Use: A disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
- Key Claim: "extractable protein content labeling claim (50 microgram per gram of glove or less)" - this implies a specific performance characteristic related to latex protein content, which is often a key criterion for latex gloves.
To answer your questions, one would need access to the actual 510(k) submission and its supporting documentation, not just the FDA's 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.