Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs, Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color.

• K Number: K142941
• Device Name: Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Tested for Use with Chemotherapy Drugs, Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color.
• Manufacturer: PT MEDISAFE TECHNOLOGIES
• Date Cleared: 2015-11-02 ( 389 days)
• Product Code: KGO , LZC
• Regulation Number: 878.4460
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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

Device Description

Powder-Free Polyisoprene Sterile Surgical Gloves in White Color Use with Chemotherapy Drugs; Powder-Free Polyisoprene Sterile Surgical Gloves in Green Color. A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

AI/ML Overview

The provided document is a 510(k) premarket notification for "Powder-free Polyisoprene Sterile Surgical Gloves." It primarily focuses on the device's substantial equivalence to predicate devices and its indications for use, particularly in protection against chemotherapy drugs.

However, the document does not contain information about acceptance criteria and a study that proves a software device meets those criteria. The document describes a physical medical device (surgical gloves) and its material properties, specifically its resistance to various chemotherapy drugs.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and reported device performance for a software device.
2. Sample size and data provenance for a test set in a software study.
3. Number and qualifications of experts for ground truth establishment for a software study.
4. Adjudication method for a software study test set.
5. MRMC comparative effectiveness study results for AI assistance.
6. Standalone performance of an algorithm.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a software study.
8. Sample size for the training set of a software algorithm.
9. How the ground truth for the training set was established for a software algorithm.

The tables provided in the document detail the "Minimum Breakthrough Detection Time (minutes)" for different chemotherapy drugs when tested with the gloves, which are performance metrics for the physical device, not a software algorithm.

Regulation Number and Section

§ 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).