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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.

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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.

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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

Note: The document explicitly states: "These Powder-Free Latex Examination Gloves meet the physical property requirements of ASTM D 3578-01 and the FDA 1000 ml water test both before and after aging. It also meets the protein labeling claim level at < 50uggl". For specific physical dimensions and attributes, the table above lists the criteria, and the "Reported Device Performance" is inferred as "Meets criteria" based on the overall conclusion.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document specifies "Inspection Parameters" with "Inspection Level" and "AQL" (Acceptable Quality Limit) values. These parameters imply a sampling plan for quality control tests, but do not directly state the specific sample size (n) for each test set. For example, "Inspection Level S-2" and "G-1" refer to sampling levels within ISO 2859-1:1999 (which is mentioned in the "Quality Assurance" section), which would then dictate the sample size based on the lot size.

• Sample size: Not explicitly stated as 'n=' for each test, but implied by inspection levels (S-2, G-1) and AQL values according to ISO 2859-1:1999.
• Data provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The manufacturer is Ascend Eagle Inc. in American Canyon, CA, but the manufacturing location (and where the testing was performed) is not specified beyond "manufactured under ISO 9001:2000."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable as the device is a physical product (latex examination gloves) and not an AI or imaging device requiring expert ground truth for interpretation. The ground truth for glove properties is established through standardized physical, chemical, and biological testing methods.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this pertained to a physical device evaluated against objective standards, not subjective expert assessment requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable, as this is a physical device (examination gloves), not an AI or imaging device involving human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable, as this is a physical device (examination gloves).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth used for the examination gloves is based on:

• Standardized physical measurements: Dimensions, tensile strength, elongation.
• Chemical analysis: Powder residue, extractable protein content.
• Performance tests: Water leak test (pinholes).
• Biocompatibility tests: Standardized tests for examination gloves (referenced in Appendix B1 and B2).
• Adherence to recognized standards: ASTM D 3578-01a, EN 455-1: 2000, EN 455-2: 2000, EN 455-3: 2000, ISO 2859-1:1999.

8. The sample size for the training set

Not applicable. The concept of a "training set" is relevant to machine learning/AI models, not to the manufacturing and testing of physical products like examination gloves. The manufacturing process would involve quality control measures, but not a "training set" in the AI sense.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set" in the context of this device.

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