FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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.

Device Description

Powder Free Latex Examination Gloves

AI/ML Overview

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for "Latex Examination Gloves, Powder Free". It indicates that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls.

The letter pertains to regulatory clearance and does not include details about:

Specific acceptance criteria (like performance metrics, accuracy thresholds, etc.)
A study proving the device meets acceptance criteria (e.g., clinical trial results, performance data)
Sample sizes for test or training sets
Data provenance or ground truth establishment
Details about expert involvement, adjudication, or MRMC studies

Therefore, I cannot fulfill your request based on the provided text.

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K Number

K964629

Device Name

VINYL PATIENT EXAMINATION GLOVES

Manufacturer

ARISTA MEDI PRIMA

Date Cleared

1997-02-10

(83 days)