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K Number
K992679
Device Name
SURGEON POWDER-FREE GLOVES, LATEX, STERILE
Manufacturer
WEAR SAFE MALAYSIA SDN. BHD.
Date Cleared
1999-10-21

(72 days)

Product Code
KGO
Regulation Number
878.4460
Type
Traditional
Panel
HO
Reference & Predicate Devices
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.

Device Description

SURGEON'S "POWDER-FREE"STERILE LATEX GLOVES

AI/ML Overview

The given text is a 510(k) clearance letter from the FDA for "Latex Surgical Gloves Powder-Free". This document primarily focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance studies and acceptance criteria analysis typical for more complex medical devices or AI algorithms.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment cannot be found in this document. The letter confirms regulatory approval for marketing, not a scientific study report with performance metrics.

However, based on the provided text, I can infer the following:

  1. Acceptance Criteria and Reported Device Performance: Not explicitly stated. The acceptance for regulatory clearance is based on "substantial equivalence" to a predicate device. This implies the device meets the basic performance and safety standards of similar legally marketed devices. For surgical gloves, this would typically involve standards related to sterility, barrier integrity (e.g., freedom from pinholes), strength, and biocompatibility, but no specific numerical criteria or reported results are in this document.

  2. Sample Size Used for Test Set and Data Provenance: Not applicable. This document does not describe a clinical study with a test set of data.

  3. Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable. This document does not describe a process of establishing ground truth by experts.

  4. Adjudication Method for the Test Set: Not applicable.

  5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This is not a study of human readers or AI assistance.

  6. Standalone Performance Study: Not applicable in the context of an algorithm. For a physical device like a glove, performance standards would have been met but are not detailed here.

  7. Type of Ground Truth Used: Not applicable.

  8. Sample Size for the Training Set: Not applicable.

  9. How Ground Truth for the Training Set Was Established: Not applicable.

Summary based on the document:

This document is a 510(k) clearance, a regulatory process to demonstrate that a device is as safe and effective as a legally marketed predicate device. It is not a report on a clinical or performance study with detailed acceptance criteria and results as typically understood for AI/ML devices or complex medical devices. The "acceptance criteria" here refer to regulatory requirements for substantial equivalence, which would have been supported by underlying testing data not included in this letter.

§ 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).