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

K Number

K974223

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Device Name

NITRILE, POWDER FREE, POLY COATED PATIENT EXAMINATION GLOVES

Manufacturer

DERLIN COMPANY LTD.

Date Cleared

1997-12-18

(36 days)

Product Code

Regulation Number

Type

Panel

Age Range

All

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

A medical gloves is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

Device Description

Nitrile Powder Free Patient Examination Gloves

AI/ML Overview

I am sorry, but the provided document is a 510(k) clearance letter for "Nitrile Powder Free Patient Examination Gloves" and an "Indication For Use Statement." It does not contain information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment for a medical device's AI component. It is a regulatory document confirming the substantial equivalence of gloves to a predicate device. Therefore, I cannot extract the requested information from this document.

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K Number

K964817

Validate with FDA (Live)

Device Name

DERLIN

Manufacturer

DERLIN COMPANY LTD.

Date Cleared

1997-01-24

(56 days)