(62 days)
A finger cot is a disposable device intended for medical purposes that is worn on the examiner's finger to prevent contamination between patient and examiner.
Latex Finger Cot, Powder-Free, with Protein Labeling
This 510(k) submission (K980827) describes a Latex Finger Cot, Powder-Free, with Protein Content Labeling Claim (50 Micrograms or Less). This device is a Class I medical device (Product Code: LZB) and is substantially equivalent to predicate devices already on the market.
1. Table of Acceptance Criteria and Reported Device Performance
The provided documentation does not include specific quantitative acceptance criteria or detailed device performance results beyond the protein labeling claim. The submission focuses on substantial equivalence to existing devices.
| Acceptance Criteria (Inferred from labeling claim) | Reported Device Performance (As stated in the device name) |
|---|---|
| Latex protein level (as indicated by the claim) | Protein Labeling Claim (50 Micrograms or Less) |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary and FDA letter do not describe a specific clinical or performance study with a test set. The submission relies on demonstrating substantial equivalence to predicate devices already on the market. Therefore, information on sample size and data provenance for a test set is not applicable here as no such study is detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
As no specific study with a test set is detailed in the provided documents, there is no mention of experts used to establish ground truth or their qualifications.
4. Adjudication Method for the Test Set
As no specific study with a test set is detailed, there is no mention of an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study is described in the provided documents. The submission focuses on substantial equivalence of the device itself, not on its impact on human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This device is a physical medical device (latex finger cot), not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only)" performance is not applicable.
7. The Type of Ground Truth Used
Given that this is a physical device and the submission focuses on substantial equivalence based on its physical characteristics and intended use, the "ground truth" would primarily refer to objective measurements of the device's properties (e.g., latex protein content, physical integrity, barrier properties) and comparison to established standards for similar devices. However, the provided documents do not detail these specific measurements or the type of ground truth used beyond the protein claim.
8. The Sample Size for the Training Set
No training set is mentioned or applicable as this is a physical medical device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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.