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The Halyard Lavender Nitrile Powder-Free Exam Glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. These gloves were tested for use with the following chemotherapy drugs:

• Cyclophosphamide (20.0 mg/ml) No breakthrough up to 240 minutes
• Doxorubicin HCl (2.0 mg/ml) No breakthrough up to 240 minutes
• Etoposide (20.0 mg/ml) No breakthrough up to 240 minutes
• 5-Fluorouracil (50.0 mg/ml) No breakthrough up to 240 minutes
• Paclitaxel (Taxol) (6.0 mg/ml) No breakthrough up to 240 minutes
• Cisplatin (1.0 mg/ml) No breakthrough up to 240 minutes
• Dacarbazine (10.0 mg/ml) No breakthrough up to 240 minutes
• Ifosfamide (50.0 mg/ml) No breakthrough up to 240 minutes
• Mitoxantrone (2.0 mg/ml) No breakthrough up to 240 minutes
• Vincristine sulfate (1.0 mg/ml) No breakthrough up to 240 minutes
• Carmustine (3.3 mg/ml) No breakthrough up to 0.3 minutes
• ThioTEPA (10.0 mg.ml) No breakthrough up to 30.9 minutes
  Warning: Not for Use With : Carmustine, ThioTEPA

Halyard® Lavender Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs are disposable, lavender-colored, chlorinated, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination gloves that are packed in a cardboard dispenser box.

The provided text describes the regulatory clearance (510(k)) for a medical device: "Halyard® Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs". This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than a clinical study evaluating AI-powered diagnostic performance. Therefore, many of the requested elements for AI/diagnostic device acceptance criteria and study design (e.g., number of experts, adjudication methods, MRMC studies, standalone performance, training sets) are not applicable to this type of device and regulatory submission.

However, I can extract the acceptance criteria and performance data relevant to this product, which primarily involve physical and chemical resistance standards for medical gloves.

Here's the information gleaned from the provided text, adapted to the context of this device:

Device: Halyard® Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs

Type of Regulatory Submission: 510(k) Premarket Notification (demonstrates substantial equivalence to a predicate device)

Study Focus: Performance of the glove against established consensus standards for medical gloves and resistance to chemotherapy drug permeation. This is not a study evaluating AI diagnostic performance or human reader improvement.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance:

The document doesn't explicitly state the exact sample sizes for each test (e.g., number of gloves tested for holes, powder). However, it indicates compliance with recognized consensus standards (e.g., ASTM D5151-06, ASTM D6319-10, ASTM D6978-05). These standards prescribe specific sampling plans and test methodologies.

• Data Provenance: The studies were conducted by the manufacturer, Halyard Health, Inc., based in Alpharetta, Georgia, USA. The data is prospective, generated specifically for this 510(k) submission to demonstrate compliance with the referenced standards. The country of origin of the data would therefore be the USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

• This question is not applicable to this type of device and study. The "ground truth" for glove performance is established by the specified methodologies and measurement limits defined within the ASTM and ISO standards themselves, not by human expert consensus or interpretation of images. The tests are laboratory-based, objective measurements (e.g., time to breakthrough, AQL for holes, mg of powder, tensile strength).

4. Adjudication Method for the Test Set:

• None. As explained above, the tests are objective laboratory measurements, not subjective human interpretations requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

• No. An MRMC study is relevant for AI-assisted diagnostic devices where human readers interpret medical images or data. This document describes the physical and chemical properties of a medical glove.

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

• No. This question is not applicable. The device is a physical glove, not an algorithm.

7. The Type of Ground Truth Used:

• Objective laboratory measurements and compliance with established consensus standards. The "ground truth" for this device's performance is derived from the results of standardized physical, chemical, and biological tests, as outlined by ASTM and ISO specifications.

8. The Sample Size for the Training Set:

• Not applicable. This device does not involve machine learning or AI models, and therefore does not have a "training set" in that context.

9. How the Ground Truth for the Training Set was Established:

• Not applicable. As above, there is no training set. The "ground truth" for the performance claims relies on the adherence to and results from validated test methods defined by international standards.

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BRIGHTWAY BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, [LAVENDER] is a disposable device intended for medical purpose, to be worn on the examiners hand or finger to prevent contamination between patient and examiner.

The subject device in this 510(k) Notification is a Lavender Examination Glove. The subject device is a patient examination glove made from a Nitrile compound, Lavender in colour, powder free and non sterile (as per 21 CFR 880.6250, class I). The principle operation of the medical device to provide single use barrier protection for the wearer and the device that meets all the requirement specifications for Barrier Protection, tensile properties as defined in ASTM D6319-10 ; Standard specification for Nitrile Examination Gloves.

Here's a breakdown of the acceptance criteria and study information for the Brightway Brand Nitrile Examination Gloves, Powder Free (Lavender), based on the provided document:

Acceptance Criteria and Reported Device Performance

Study Information

1. Sample size used for the test set and the data provenance:

   • Dimension Measurement: 20 pieces per batch. Random Sampling based on ISO2859-1:1999; S2 AQL 2.5, Ac=1 Rej=2.
   • Water-tight Test: 200 pieces per batch. Random Sampling based on ISO2859-1:1999; G2 AQL 1.5, Ac=7 Rej=8.
   • Physical Properties Analysis: Not explicitly stated but "Single Normal S2 AQL: 2.5 Acc/Rej : 1/2" for sampling plan. Given that 20 samples were tested and individual results are shown, it seems 20 samples were used for the physical properties test.
   • Biocompatibility Studies (Primary Skin Irritation, Dermal Sensitization, Systemic Toxicity): Sample sizes for these tests are not provided in the document.
   • Data Provenance: The tests were conducted by Brightway Holdings Sdn Bhd (the manufacturer) in Malaysia. The document does not specify if the data is retrospective or prospective, but as it's part of a 510(k) submission for a new device, it would typically involve prospective testing of newly manufactured devices.

2. 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 information is not applicable to the device described. The "ground truth" for examination gloves is established by standardized physical and chemical testing methods (ASTM, ISO), not by expert consensus or interpretations.

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

   • Not applicable. Performance is measured against objective standards, not subjective interpretations requiring adjudication.

4. 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. This device is an examination glove, not an AI-powered diagnostic or assistive tool.

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

   • Not applicable. This device is an examination glove, not an algorithm.

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

   • The "ground truth" for this device is based on objective, standardized measurements and tests outlined in recognized standards such as ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves), ASTM D5151 (Water Leak Test), ASTM D6124 (Residual Powder), and ISO 10993 (Biocompatibility).

7. The sample size for the training set:

   • Not applicable. This device is not an AI/machine learning model that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable. This device is not an AI/machine learning model.

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