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K Number
K162852
Device Name
Finessis Zero Chemo Flexylon Powder Free Sterile White Surgical Glove
Manufacturer
Lucenxia Prescience AG
Date Cleared
2017-02-08

(120 days)

Product Code
KGO,LZC
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

This surgeon's glove is a device made of Flexylon intended to be worn by operating room personnel to protect a surgical wound from contamination. These Gloves are tested for use with Chemotherapy Drugs DO NOT USE with Carmustine or Thiotepa Chemical Resistance Data per ASTM D 6978-05

Device Description

This surgeon's glove is a device made of Flexylon intended to be worn by operating room personnel to protect a surgical wound from contamination. Flexylon; a styrene-ethylene/butylene-styrene (SEBS) material.

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for a surgical glove. It contains information about the device's name, regulation number, product code, and intended use, specifically highlighting its resistance to certain chemotherapy drugs.

However, the document does NOT contain information about an AI-powered medical device, nor does it detail acceptance criteria, study methodologies for proving device performance (such as test set sample sizes, data provenance, expert qualifications, or ground truth establishment), or MRMC studies.

Therefore, I cannot extract the requested information regarding:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size for the test set and data provenance.
  3. Number of experts and their qualifications for ground truth.
  4. Adjudication method for the test set.
  5. MRMC comparative effectiveness study details or effect size.
  6. Standalone algorithm performance.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

This document pertains to the clearance of a physical medical device (surgical gloves) based on material properties and chemical resistance, not an AI or software as a medical device (SaMD) that typically undergoes the type of performance evaluation described in your request.

§ 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).