(35 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Latex Examination Gloves, Powder Free, Polymer Coated
This is an FDA 510(k) clearance letter for "Latex Examination Gloves, Powder Free, Polymer Coated". This document is a regulatory approval, not a scientific study report. Therefore, it does not contain the detailed information requested regarding acceptance criteria, device performance, study design, or ground truth establishment.
Here's why the requested information cannot be extracted and what the document does provide:
- No Acceptance Criteria or Device Performance Table: The document states that the device is "substantially equivalent" to legally marketed predicate devices. It does not provide specific performance metrics (e.g., tensile strength, puncture resistance, barrier integrity) or the acceptance criteria for those metrics. This level of detail would typically be found in the 510(k) submission itself, not the clearance letter.
- No Study Details (Sample Size, Data Provenance, Ground Truth, Training Set): As this is a clearance letter and not a study report, it does not describe any specific studies conducted by the manufacturer to demonstrate performance. The "substantial equivalence" determination relies on demonstrating that the new device is as safe and effective as a predicate device already on the market, often through comparison of materials, design, and intended use, and sometimes through performance testing if there are significant differences from the predicate. However, the details of such testing, if performed, are not in this letter.
- No Information on Experts, Adjudication, or MRMC Studies: These concepts are typically relevant for AI/ML-based diagnostic devices or complex imaging analysis, where expert interpretation and consensus are crucial for establishing ground truth and evaluating human-AI interaction. This document is for a physical medical device (examination gloves), so these types of studies are not applicable or mentioned.
- Standalone Performance: The concept of "standalone performance" (algorithm only) is not relevant to a physical medical device like gloves.
What the document does tell us:
- Device Name: Latex Examination Gloves, Powder Free, Polymer Coated
- Regulation Number & Product Code: 880.6250, LYY (Patient Examination Gloves)
- Regulatory Class: I (lowest risk class, subject to general controls)
- Indications For Use: A disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
- Date of Clearance: June 7, 2002
- Type of Clearance: 510(k) Premarket Notification, based on "substantial equivalence" to a predicate device.
To obtain the detailed information requested, one would need to access the original 510(k) submission (K021412), which is usually publicly available through the FDA's databases, although often redacted for proprietary information. That submission would describe the specific tests performed (e.g., physical property testing, biocompatibility, leak testing) and the criteria used to demonstrate that the gloves meet recognized standards and are substantially equivalent to marketed predicate devices.
§ 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.