(113 days)
The glove is disposable and intended for Medical purpose that is worn on the hand of healthcare and similar personnel to prevent contamination between the patient and the examiner.
Polymer Coated Powderfree Latex Examination Gloves
This document is a 510(k) Premarket Notification for a medical device. It's an FDA clearance letter and an "Indications for Use" statement, not a scientific study report. Therefore, it does not contain the information requested regarding acceptance criteria, device performance details, study design, or ground truth establishment.
Here's why and what's missing:
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Acceptance Criteria and Reported Device Performance: This document states the device (Polymer Coated Powder-Free Latex Examination Gloves) is "substantially equivalent" to legally marketed predicate devices. It does not present specific acceptance criteria (e.g., tensile strength, puncture resistance, barrier integrity) or reported device performance data against those criteria. Such data would typically be found in test reports submitted as part of the 510(k) application, but not in the FDA's clearance letter itself.
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Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set): A 510(k) submission for examination gloves primarily relies on bench testing to demonstrate performance characteristics (like those related to barrier integrity and physical properties) and comparison to a predicate device for substantial equivalence. It is highly unlikely that the types of studies described in the prompt (e.g., MRMC comparative effectiveness studies, studies involving experts for ground truth, large-scale clinical trials with human readers) would be conducted or required for this type of Class I device.
- For example, proving substantial equivalence for gloves typically involves testing attributes like:
- Dimensional specifications
- Tensile strength and elongation
- Puncture resistance
- Water leak test (for barrier integrity)
- Protein content (for latex gloves)
- Powder residue (for powder-free gloves)
These tests are performed on a statistical sample of the manufactured gloves according to recognized standards (e.g., ASTM, ISO). The "ground truth" for these measurements is the physical measurement itself, not an expert consensus or pathology report.
- For example, proving substantial equivalence for gloves typically involves testing attributes like:
In summary, the provided document is a regulatory clearance and not a study report. It confirms the device's substantial equivalence but does not detail the specific performance criteria or the studies used to demonstrate compliance.
§ 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.