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

FDA 510(k) Search

K Number

Device Name

POWDER FREE PATIENT EXAMINATION GLOVE SAFE GLOVE

Manufacturer

SAFE GLOVE LTD.

Date Cleared

1998-01-16

(101 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Predicate For

N/A

Intended Use

According to 21 CFR, a 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.

Device Description

POWDER FREE LATEX PATIENT EXAMINATION GLOVES

AI/ML Overview

I am sorry, but the provided text does not contain the necessary information to answer your request. The document is an FDA 510(k) clearance letter for "POWDER FREE LATEX PATIENT EXAMINATION GLOVES" and does not detail acceptance criteria or a study that proves the device meets such criteria. It primarily addresses the regulatory approval of the gloves based on substantial equivalence.

Summary

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.