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Found 2 results

510(k) Data Aggregation

K Number

Device Name

RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE)

Manufacturer

RIVERSTONE RESOURCES SDN. BHD.

Date Cleared

2000-10-26

(9 days)

Product Code

Regulation Number

Type

Panel

General Hospital

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE)

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Device Name

RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE)

Manufacturer

RIVERSTONE RESOURCES SDN. BHD.

Date Cleared

1999-05-26

(64 days)

Product Code

Regulation Number

Type

Panel

General Hospital

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

RS NITRILSTAT MEDICAL EXAMINATION GLOVES, POWDER FREE (NON-STERILE)

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

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

Device Description

RS Nitrilstat Medical Examination Gloves, Powder Free (Non-Sterile)

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for medical examination gloves. It does not contain information about the acceptance criteria or a study proving that a device meets such criteria. Therefore, I cannot provide the requested information based on the given input.

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