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HALYARD* PURPLE NITRILE - XTRA* Powder Free Exam Gloves tested for Use with Chemotherapy Drugs are powder-free patient examination gloves that are a disposable device intended for medical purposes worn on the examiner's hand or finger to prevent contamination between patient and examiner. This is an over the counter medical device. The HALYARD* PURPLE NITRILE - XTRA* Powder Free Exam Gloves have been tested with the following Chemotherapy drugs showing no breakthrough up to 240 minutes. Carmustine showed breakthrough at 80.4 minutes.

Device Description

HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves are 12" disposable, purple-colored, nitrile, powder-free, textured fingertip, ambidextrous, non-sterile patient examination gloves that have been tested for use with chemotherapy drugs.

AI/ML Overview

The provided text describes the acceptance criteria and performance data for HALYARD PURPLE NITRILE – XTRA Powder-Free Exam Gloves**, specifically regarding their resistance to chemotherapy drugs and other physical properties.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Test Standard	Acceptance Criteria	Reported Device Performance
ASTM D6978-05: Resistance to Permeation by Chemotherapy Drugs	No signs of breakthrough after 4 hours (>240 minutes) for most drugs. Specific breakthrough time for Carmustine set at 30.7 minutes for predicate device.	No breakthrough observed for most chemotherapy drugs up to 240 minutes. Carmustine showed breakthrough at 80.4 minutes (at 3.3 mg/ml concentration). This exceeds the predicate's Carmustine breakthrough time of 30.7 minutes, indicating improved performance.
ASTM D5151-06: Detection of Holes in Medical Gloves	2.5% AQL (Acceptable Quality Level) for leakage.	Meets the 2.5% AQL requirement. (Halyard Specification: AQL 1.0%)
ASTM D6124-06: Residual Powder on Medical Gloves	< 2 mg maximum powder per glove (powder-free limit).	Residual powder is within the powder-free limit of < 2 mg/glove.
ASTM D6319-10: Nitrile Examination Gloves for Medical Applications (Physical Dimensions & Properties)	Physical Dimensions:- Length: ≥ 230 mm- Width: 85-105 mm- Finger Thickness: ≥ 0.05 mm- Palm Thickness: ≥ 0.05 mmPhysical Properties:- Unaged Tensile: ≥ 14 MPa- Unaged Elongation: ≥ 500%- Aged Tensile: ≥ 14 MPa- Aged Elongation: ≥ 400%	Physical Dimensions:- Length: 295-325 mm- Width: 85-105 mm- Finger Thickness: 0.11-0.19 mm- Palm Thickness: 0.11-0.16 mmPhysical Properties:- Unaged Tensile: ≥ 14 MPa- Unaged Elongation: ≥ 500%- Aged Tensile: ≥ 14 MPa- Aged Elongation: ≥ 500% (All conform to or exceed ASTM D6319)
ISO 10993-10: Tests for Irritation	No erythema/edema up to 72 hours post exposure (for predicate device).	Based on an evaluation according to ISO 10993-1, no additional testing on the subject glove was needed as it was deemed substantially equivalent to the predicate which met this criterion with negligible erythema/edema.
ISO 10993-10: Tests for Skin Sensitization	No evidence of delayed dermal contact sensitivity at 24 and 48 hours post injection (for predicate device).	Based on an evaluation according to ISO 10993-1, no additional testing on the subject glove was needed as it was deemed substantially equivalent to the predicate which met this criterion (not a sensitizer).
ISO 10993-11: Tests for Systemic Toxicity	No signs of systemic toxicity up to 72 hours post injection (for predicate device).	Based on an evaluation according to ISO 10993-1, no additional testing on the subject glove was needed as it was deemed substantially equivalent to the predicate which met this criterion (no systemic toxicity observed).

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

The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for permeation, holes, etc.). However, it refers to industry standards (ASTM, ISO) which typically include defined sampling plans.

Data Provenance: The testing was conducted by Halyard Health, an American company. The data is retrospective, as it was submitted for a 510(k) premarket notification to demonstrate substantial equivalence to an already marketed device. The specific country of origin for the raw test data is not stated but would presumably be the testing labs contracted by Halyard Health.

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

This information is not applicable to this type of device and study. The "ground truth" here is based on objective, standardized laboratory tests according to ASTM and ISO standards, not expert interpretation of medical images or clinical outcomes. The results are quantitative measurements (e.g., breakthrough time, physical dimensions, AQL values) determined by laboratory protocols.

4. Adjudication Method for the Test Set

This is not applicable. As mentioned above, the tests are objective, standardized laboratory measurements, not subjective evaluations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

This is not applicable. This is a study on the physical and chemical barrier properties of medical gloves, not an AI-based diagnostic device requiring MRMC studies.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This is not applicable. This is a physical medical device (gloves), not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" is established through standardized laboratory testing and measurements based on widely accepted international and national standards (ASTM D6978-05, ASTM D5151-06, ASTM D6124-06, ASTM D6319-10, ISO 10993-10, ISO 10993-11). These standards define the methodologies for assessing properties like chemical permeation, presence of holes, residual powder, and physical characteristics.

8. The Sample Size for the Training Set

This is not applicable. This is a physical device being tested against established performance standards, not an AI model that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reason as point 8.

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