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The powder free chemotherapy examination glove is a specialty medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or forefinger to prevent contamination between examiner and patient bodily fluids, waste or environment. Tested for use with chemotherapy drugs. Tested chemotherapy drugs are as follows [Cyclophosphamide, Carmustine, Thio-Tepa, Dacarbazine, Doxorubicin Hydrochloride; 5- Fluorouracil, Cisplatin, Etoposide, and Paclitaxel] WARNING: DO NOT USE GLOVES WITH THIO-TEPA AND CARMUSTINE

Powder Free Blue Latex Examination Gloves 18 Mil, with Chemotherapy Drugs & Protein Content Labeling Claim meets all the requirements of ASTM standard D6978-05, D5712-05°1 and FDA 21 CFR 880.6250.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Powder Free Blue Latex Patient Examination Gloves:

This document is a 510(k) summary for a medical device (examination gloves), which primarily relies on demonstrating substantial equivalence to a predicate device and adherence to recognized performance standards. Therefore, the "study" described is a series of compliance tests rather than a clinical trial or a typical algorithmic performance study.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes used for each individual test (e.g., how many gloves were tested for dimensions, watertightness, etc.). However, these are standard laboratory tests typically performed on a statistically significant sample of units from production batches according to the respective ASTM standards.

Data Provenance: The document does not specify the country of origin for the data, but the manufacturer is WRP Asia Pacific Sdn Bhd in Malaysia. The tests are non-clinical, laboratory-based, and as such, are prospective in the sense that they are conducted specifically to demonstrate compliance with the standards for this submission, rather than retrospective analysis of existing data.

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

This is not applicable in the context of this device and study. The "ground truth" for examination gloves is defined by adherence to established, objective, and standardized performance criteria set forth by organizations like ASTM. The tests are quantifiable and measurable against these engineering standards, not through subjective expert consensus.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective and based on measurable parameters defined by ASTM standards. There is no need for human adjudication of results that are determined by laboratory measurements (e.g., a glove either meets the thickness specification or it doesn't).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically conducted for diagnostic imaging devices or algorithms where human interpretation is a critical component and the AI's impact on human performance is being evaluated. This device is a physical barrier (glove), not an AI-powered diagnostic tool.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

Yes, in a way. The performance evaluation is entirely "standalone" in the sense that it assesses the intrinsic physical and chemical properties of the glove itself against defined standards. There is no "algorithm" in the traditional sense, nor is there a human-in-the-loop interacting with a software component. The device's performance is its inherent characteristic, evaluated in isolation through laboratory testing.

7. Type of Ground Truth Used

The ground truth used is based on established engineering and performance standards (e.g., ASTM standards for dimensions, physical properties, watertightness, protein level, and chemical permeation resistance). Biocompatibility is assessed against pass/fail criteria for irritation and sensitization. These are objective, measurable criteria, not expert consensus, pathology, or outcomes data in the usual clinical sense.

8. Sample Size for the Training Set

Not applicable. This device is a physical product (glove), not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no training set for this device.

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