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K Number
K052030
Device Name
SURGEON'S GLOVE, POWDER FREE
Manufacturer
SHUN THAI RUBBER GLOVES INDUSTRY PUBLIC CO., LTD.
Date Cleared
2005-09-13

(48 days)

Product Code
KGO
Regulation Number
878.4460
Type
Traditional
Panel
General Hospital
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Royal Guard Latex, Powder-Free, Surgeon's Glove - Sterile, is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination between patient and operating room personnel.

Device Description

The Royal Guard Latex, Powder-Free, Surgeon's Glove - Sterile, is a device made of natural or synthetic rubber.

AI/ML Overview

I am sorry, but the PDF provided does not contain the information requested. The document is a 510(k) premarket notification letter from the FDA regarding "Surgeon's Glove Powder Free" and does not include details about acceptance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/device performance study.

§ 878.4460 Non-powdered surgeon's glove.

(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's 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).