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510(k) Data Aggregation
K Number
K112988Manufacturer
Date Cleared
2011-11-09
(34 days)
Product Code
Regulation Number
880.6250Type
TraditionalPanel
General HospitalReference & Predicate Devices
Why did this record match?
Applicant Name (Manufacturer) :
NORTHSTAR HEALTHCARE HOLDINGS LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The 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 Exam Glove, Smooth and Textured Natural Color (Off White) with Protein Labeling Claim (50 µg/dm² or less of water soluble protein)
AI/ML Overview
Acceptance Criteria and Device Performance for Powder Free Latex Patient Exam Glove
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimension | ASTM Standard D3578 | Meets |
| Physical Properties | ASTM Standard D3578 | Meets |
| Freedom from Pinholes | 21 CFR 800.20; ASTM D5151 | Meets |
| Powder Residual | ASTM Standard D6124 (specifically, |
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