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K Number
K030445
Device Name
POWDER FREE LATEX MICROSURGERY GLOVES WITH BROWN COLOR AND PROTEIN LABELING CLAIM OF 50 MICROGRAMS OR LESS PROTEIN GRAM
Manufacturer
PRIMUS GLOVES PRIVATE LTD.
Date Cleared
2003-06-05

(114 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

A Surgeons glove is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Device Description

POWDERFREE LATEX MICROSURGERY GLOVES BROWN COLOR

AI/ML Overview

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving device performance. The document is a 510(k) premarket notification letter from the FDA to Primus Gloves Private Limited regarding their Powder Free Latex Microsurgery Gloves. It states that the device has been found substantially equivalent to legally marketed predicate devices and outlines the general controls and regulations the company must adhere to.

Therefore, I cannot provide the requested information, including:

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

§ 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).