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K Number
K123628
Device Name
STERILE LATEX SURGICAL GLOVE
Manufacturer
LUCENXIA PRESCIENCE AG
Date Cleared
2013-03-18

(115 days)

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

A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded.

Device Description

FINESSIS PERSONAL Latex Powder Free Sterile Surgical Gloves with Protein Claim.

AI/ML Overview

This document is related to the FDA's 510(k) premarket notification for "FINESSIS PERSONAL Latex Powder Free Sterile Gloves with Protein Claim." This is a regulatory clearance document for a medical device (surgical gloves), not a study report for an AI/ML powered medical device.

Therefore, the requested information about acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment is not available in the provided text because the text describes the regulatory clearance of surgical gloves, not an AI/ML device and its performance study.

The document discusses:

  • The trade/device name: FINESSIS PERSONAL Latex Powder Free Sterile Gloves with Protein Claim.
  • Regulation Number and Name: 21 CFR 878.4460, Surgeon's Glove.
  • Regulatory Class: I.
  • Product Code: KGO.
  • Indications for Use: A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. The lubricating or dusting powder used in the glove is excluded.

Questions regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth are typically asked for AI/ML diagnostic or prognostic devices that perform specific analyses on data (e.g., images, physiological signals), where "performance" relates to diagnostic accuracy (sensitivity, specificity, AUC) or similar metrics. This document does not describe such a device or 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).