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510(k) Data Aggregation

K Number

Device Name

NON-STERILE, POWER FREE YELLOW LATEX EXAMINATION GLOVES

Manufacturer

Date Cleared

2012-09-12

(363 days)

Product Code

Regulation Number

Type

Panel

General Hospital

Reference & Predicate Devices

N/A

Why did this record match?

Device Name :

NON-STERILE, POWER FREE YELLOW LATEX EXAMINATION GLOVES

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

The Non-Sterile, Powder-Free Yellow Latex Examination Glove With Tutti Flavour and With Protein Labeling Claim of

Device Description

Non-Sterile, Powder-Free Yellow Latex Examination Gloves With Tutti Frutti Flavour and with Protein Labeling Claim of

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for "Non-Sterile, Powder-Free Yellow Latex Examination Gloves with Tutti Frutti Flavour and with Protein Labeling Claim of

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