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510(k) Data Aggregation
K Number
K972187Device Name
BOUFFANT CAPManufacturer
Date Cleared
1997-09-09
(91 days)
Regulation Number
878.4370Type
TraditionalPanel
General HospitalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The Bouffant Cap is a device intended to be worn by hospital personnel during procedures to protect both the patient and the hospital personnel from transfer of microorganisms, body fluids and particulate materials.
Device Description
Bouffant Cap
AI/ML Overview
The provided text is a letter from the FDA regarding the clearance of a "Bouffant Cap" device. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot fulfill the request using the provided input. The document is a regulatory approval letter, not a scientific study report.
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K Number
K953878Device Name
BOUFFANT CAPManufacturer
Date Cleared
1996-01-05
(142 days)
Product Code
Regulation Number
878.4040Type
TraditionalReference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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