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K Number
K990710
Device Name
BARRIERPLUS SYNTHETIC POWDER-FREE SURGICAL GLOVES
Manufacturer
BARRIERMED GLOVE CO.
Date Cleared
1999-05-20

(77 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

These gloves are intended for use in sterile environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive surgical procedures as well as noninvasive activities requiring sterility. They are designed to be worn by operating room personnel to protect a surgical wound from contamination and to protect the user from blood-borne pathogens.

Device Description

Synthetic Powder-Free Surgical Gloves

AI/ML Overview

Unfortunately, based on the provided text, I cannot extract the specific information requested about acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for "BarrierPlus™ Synthetic Powder-Free Surgical Gloves."

Here's why the requested information is not available in the provided text:

  • Nature of the Document: This is a regulatory clearance letter, not a detailed technical report or study summary. It states that the device is "substantially equivalent" to previously marketed devices, meaning it doesn't need to undergo new, extensive efficacy studies if it's demonstrated to be as safe and effective as a predicate device.
  • Focus of the Document: The letter confirms market clearance, lists the product code and classification, and outlines general regulatory obligations. It does not contain clinical trial data, performance metrics, or details about ground truth establishment.
  • Missing Information: All the specific points you asked for (acceptance criteria table, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set size, training ground truth establishment) are typical components of a study report, which is not this document.

What the document does tell us about performance (indirectly):

  • Indications for Use (Page 2): "These gloves are intended for use in sterile environments within hospitals and other healthcare facilities. The gloves are appropriate for use during invasive surgical procedures as well as noninvasive activities requiring sterility. They are designed to be worn by operating room personnel to protect a surgical wound from contamination and to protect the user from blood-borne pathogens."
  • Substantial Equivalence: The FDA's determination of "substantial equivalence" implies that the device performs comparably to a predicate device already on the market for these indications. This process relies on comparing the new device's technological characteristics and performance data (which would have been submitted in the 510(k) application but is not in this letter) to the predicate device.

To get the information you're looking for, you would need access to the full 510(k) submission (K990710) submitted by BarrierMed Glove Company, which would contain the performance data and comparisons to predicate devices. This letter only summarizes the FDA's decision based on that submission.

§ 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).