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K Number
K962986
Device Name
MAXXUS POWDER FREE ORTHOPAEDIC LATEX SURGICAL GLOVES
Manufacturer
JOHNSON & JOHNSON MEDICAL, INC.
Date Cleared
1996-09-20

(50 days)

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

MAXXUS Powder Free Orthopaedic Latex Surgical Gloves are Intended to protect the wearer from liquids such as body fluids and blood, as well as to protect surgical wounds or sterile fields from microbiological contamination from the wearer.

Device Description

MAXXUS Powder Free Orthopaedic Latex Surgical Gloves meet the description of Rubber Surgical Gloves as described in American Society for Testing Materials (ASTM D 3577- 91) as Type 1 gloves compounded primarily from rubber latex. They are brown in color and are non-powdered. They are packaged sterile in pairs in sizes 5-1/2 through 9.

AI/ML Overview

The provided text describes a medical device, MAXXUS* Powder Free Orthopaedic Latex Surgical Gloves, and its testing for regulatory approval. However, it does not include information about a study proving the device meets acceptance criteria in the context of an AI/ML medical device submission. The document is a 510(k) summary for a surgical glove, which is a very different type of medical device.

Therefore, I cannot fulfill the request to provide acceptance criteria and study details as it pertains to an AI/ML device. The information provided is about the physical and chemical properties of a physical medical device (gloves).

Here's why the provided text doesn't fit the request:

  • Device Type: The device is "MAXXUS* Powder Free Orthopaedic Latex Surgical Gloves," a physical product, not an AI/ML algorithm.
  • Tests Described: The tests mentioned are for physical properties (ASTM D-3577-91, 21 CFR 800.20, primary skin irritation, delayed contact sensitization, USP iodine test for starch). These are relevant for gloves, not for evaluating the performance of an AI model.

Therefore, all the specific points requested (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth type, training set size, training set ground truth) are not applicable to the provided document.

§ 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).