BLUE POWDER-FREE NITRILE EXAMINATION GLOVES

• K Number: K990283
• Device Name: BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
• Manufacturer: HARTALEGA SDN BHD
• Date Cleared: 1999-03-09 ( 39 days)
• Product Code: LZA
• Regulation Number: 880.6250
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The patient examination gloves is a disposable device intended for medical and dental purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Description

Blue Powder Free Nitrile Examination Gloves

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for "Blue Powder-Free Nitrile Examination Gloves." This type of document does not contain information about acceptance criteria or a study proving device performance in the context of an AI/medical device.

The FDA 510(k) process is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. It does not typically involve detailed performance studies with acceptance criteria in the way an AI/software as a medical device (SaMD) would. Instead, substantial equivalence is often based on material properties, design, manufacturing processes, and adherence to recognized standards for physical characteristics (like tensile strength, puncture resistance, etc.).

Therefore, I cannot provide the requested information based on the given document.

To clarify for future reference, if you were to provide a document describing an AI/SaMD, the typical information you'd look for to answer your request would include:

1. Acceptance Criteria Table: A table explicitly listing performance metrics (e.g., sensitivity, specificity, AUC) and their target values.
2. Study Design Section: Details on the prospective/retrospective nature of the study, data sources (countries, institutions), and the size of the test set.
3. Ground Truth Establishment: How the ground truth for the test set was determined, including the number and qualifications of experts involved.
4. Adjudication Method: If multiple experts were used, how disagreements were resolved (e.g., 2+1, 3+1).
5. Comparative Effectiveness Study: Information on MRMC studies, if conducted, and the reported improvement of human readers with AI assistance.
6. Standalone Performance: If the algorithm's performance was evaluated independently without human intervention.
7. Type of Ground Truth: The gold standard used for ground truth (e.g., pathology, surgical findings, long-term follow-up).
8. Training Set Details: The size of the dataset used to train the AI model.
9. Training Set Ground Truth: How the ground truth for the training set was established.

Regulation Number and Section

§ 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.