UNIJECT EXAMINATION GLOVES

• K Number: K970191
• Device Name: UNIJECT EXAMINATION GLOVES
• Manufacturer: UNIJECT GLOVES LTD.
• Date Cleared: 1997-07-03 ( 168 days)
• Product Code: LYY
• Regulation Number: 880.6250
• Type: Traditional
• Panel: General Hospital
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

A patient examination gloves 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,

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA regarding "Uniject Latex Examination Gloves (Powdered)." It confirms that the device is substantially equivalent to legally marketed predicate devices.

No acceptance criteria or study details are provided in the document.

The document primarily focuses on the regulatory approval of the gloves based on substantial equivalence. It does not contain information about:

1. Acceptance criteria table or reported device performance: This document explicitly states substantial equivalence, which means the device performs as well as an already-approved predicate device. It doesn't present specific performance metrics or acceptance criteria for those metrics.
2. Sample size for the test set or data provenance: No performance testing data is presented or referenced.
3. Number of experts and qualifications for ground truth: Not applicable as no specific study data requiring ground truth establishment is detailed.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone performance: Not applicable. The approval is based on substantial equivalence to existing devices, not a standalone performance study as described for AI algorithms.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable as this is not an AI/ML device requiring a training set.
9. How ground truth for the training set was established: Not applicable.

The document is a regulatory approval letter, not a device performance study report.

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.