Search Results

These Non-Sterile, Powder-Free Peach Color, Nitrile Examination Gloves with Lano-E and Peppermint Citrus Scent, are a disposable (single-use-only) device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Non-Sterile, Powder-Free PEACH Color, Nitrile Examination Gloves with Lano-E and Peppermint Citrus Scent

This document is a 510(k) premarket notification approval letter for examination gloves. It does not contain information regarding software or AI/ML acceptance criteria or a study proving device performance against such criteria. Therefore, I cannot provide the requested information.

Ask a specific question about this device

These Non-Sterile, Powder-Free, AQUA NITRILE Examination Gloves with Lano-E and Peppermint Citrus Scent, are a disposable (single-use-only) device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Non-Sterile, Powder Free, AOUA NITRILE Examination Gloves with Lano- E and Peppermint Citrus Scent

I cannot fulfill this request. The provided text is a Food and Drug Administration (FDA) clearance letter for a medical device (examination gloves), not a study report or clinical trial documentation. Therefore, it does not contain information about acceptance criteria, device performance metrics, study designs, sample sizes, ground truth establishment, or any of the other specific details requested in the prompt. This document attests to the substantial equivalence of the device to legally marketed predicate devices, but it does not present the results of a study that would "prove the device meets acceptance criteria" in the way described in the prompt.

Ask a specific question about this device

The Non-Sterile, Powder-Free, Latex Examination Gloves, with Lanolin and Vitamin E Coating, Natural or Green Colonese &acmination (Hores, With Lanoin and Vitamin F and with Protein Labelian Claim (Combined Citrus-Peppermint), and with Protein Labeling Claim (50 micrograms or less total water extractable protein per gram of glove) is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Non-Sterile Powder-Free Natural/Green Lano-E Latex Exam Gloves, with or without Citrus/Peppermint scent plus a protein labeling claim. (Multiple Private Labels) Common Name: Latex Examination Gloves Classification Name: Patient Examination Glove (per 21 CFR 880.6251) Class I: Powder-Free Latex examination glove 80LYY that meets all of the requirements of ASTM Standard D 3578-01aE2.

The provided document is a 510(k) premarket notification for "Non-Sterile, Powder-Free, Latex Examination Gloves" and does not describe a study involving an algorithm or AI. Therefore, I cannot provide information on acceptance criteria and a study that proves a device meets them in the context of AI/algorithm performance.

However, I can extract the acceptance criteria and reported performance for the latex examination gloves as presented in the document, which primarily focuses on physical and chemical properties of the gloves.

Here's the information based on the provided text, adapted to the closest relevant categories:

1. A table of acceptance criteria and the reported device performance

Ask a specific question about this device