K Number
K102177
Date Cleared
2011-06-30

(332 days)

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

The surgeon's glove is a device made of synthetic rubber latex intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.

Device Description

SensiCare Powder-Free Polymer Coated Polyisoprene Surgical Gloves, Sterile, Coated with Aloe Vera, Natural or Turquoise (Green) Color.

AI/ML Overview

The provided text {0} {1} {2} is an FDA 510(k) clearance letter for a medical device: "SensiCare Powder-Free Polymer Coated Polyisoprene Surgical Gloves, Sterile, Coated with Aloe Vera, Natural or Turquoise (Green) Color." This document primarily grants marketing clearance based on substantial equivalence to a predicate device and outlines general regulatory obligations.

Crucially, this document does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding ground truth establishment, sample sizes for training/test sets, expert qualifications, or adjudication methods.

Therefore, I cannot provide the requested information from the given text.

The closest information available is:

  • Device Name: SensiCare Powder-Free Polymer Coated Polyisoprene Surgical Gloves, Sterile, Coated with Aloe Vera, Natural or Turquoise (Green) Color.
  • Regulation Number: 21 CFR 880.6250
  • Regulation Name: Patient Examination Glove
  • Regulatory Class: I
  • Product Code: KGO
  • Indications For Use: "The surgeon's glove is a device made of synthetic rubber latex intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination."

To fulfill your request, I would need a different document, such as the full 510(k) submission, a clinical study report, or a summary of safety and effectiveness, which would detail the specific performance testing and results conducted for this glove.

§ 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).