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K Number
K202668
Device Name
Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm2 per Glove of Extractable Protein
Manufacturer
Medline Industries, Inc.
Date Cleared
2020-12-19

(96 days)

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

The surgeon's glove is a device made of natural rubber latex intended to be worn by surgeon's and or operating room personnel to protect a surgical wound from contamination. In addition these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.

Device Description

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

AI/ML Overview

This document is a 510(k) clearance letter for surgical gloves, not a study report for an AI/ML device. Therefore, it does not contain the information required to answer the questions about acceptance criteria and study details for an AI/ML device.

Specifically, the document discusses:

  • The trade name and regulation of "Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove".
  • The FDA's determination of substantial equivalence for this medical device.
  • The "Indications for Use" for the gloves, particularly their testing for use with chemotherapy drugs based on ASTM D6978.
  • Breakthrough times for various chemotherapy drugs when tested with "Signature Latex" and "Signature Latex Micro" gloves.
  • Warnings against using the gloves with Carmustine and Thiotepa due to short breakthrough times.

There is no mention of any AI/ML components, acceptance criteria for an AI/ML algorithm, or details of a study proving such a device meets specific performance criteria.

§ 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).