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

A patient examination glove is a disposable device intended for medical purposes, that is worn on It pation oxamination grove is a sevent contamination between patient and examiner.

Device Description

Colored Ambiderm Powder-Free Examination Gloves with Protein Labeling Claim. (White, Violet, Green, Yellow, Orange, Pink & Blue) .

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Ambiderma Colored Powder-Free Latex Examination Glove). This document confirms the device's substantial equivalence to a predicate device and permits its marketing.

However, it does not contain any information about acceptance criteria for device performance or details of a study conducted to prove the device meets such criteria. The letter focuses on regulatory approval based on equivalence, not on the results of a performance study with specific metrics, sample sizes, or ground truth establishment—which are typically found in a detailed study report or scientific publication.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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K Number

K963866

Device Name

AMBIDERM (WHITE POW LATEX EXAM GLOVES W/ PROTEIN)

Manufacturer

SUPERTEX INDUSTRIAL, S.A. DE C.V.

Date Cleared

1997-02-10

(210 days)

Product Code