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Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs. Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid are disposable devices intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes: Cisplatin. 1 mg/ml Cyclophosphamide, 20 mg/ml Dacarbazine, 10 mg/ml Doxorubicin HCl. 2 mg/ml Etoposide, 20 mg/ml Fluorouracil. 50 mg/ml lfosfamide, 50 mg/ml Mitoxantrone HCl, 2 mg/ml Paclitaxel, 6 mg/ml Vincristine Sulfate, 1 mg/ml

CAUTION: The following chemotherapy drug and concentration showed breakthrough detected in less than 60 minutes: Carmustine, 3.3 mg/ml: No breakthrough up to 35.1 minutes.

CAUTION: The following chemotherapy drug and concentration showed breakthrough detected in less than 120 minutes: Thiotepa. 10 mg/ml: No breakthrough up to 107.2 minutes.

Warning: Not for use with Carmustine, Thiotepa

The following hazardous drugs (opioids) and concentration had NO breakthrough detected up to 240 minutes:

Fentanyl Citrate Injection (50 mcg/5 ml)
Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution

Device Description

The subject device is a disposable, 9.5" black-colored, chlorinated, nitrile, powder-free, textured, ambidextrous, non-sterile patient examination glove that is packed in a cardboard dispenser box.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Halyard Black Nitrile Powder-Free Exam Gloves.

Based on the provided K242558 510(k) summary, the device is a medical glove, and the studies performed are non-clinical, primarily focused on physical properties, biocompatibility, and resistance to chemical permeation. This is not a study assessing AI performance or human reader effectiveness.

Acceptance Criteria and Reported Device Performance

Test Method	Standard	Acceptance Criteria	Reported Performance
Dimensions	ASTM D6319	Length: ≥230 mm	PASS
		Palm Width Size: X-Small: 60 – 80 mm; Small: 70 - 90 mm; Med: 85–105 mm; Large: 100 - 120 mm; X-Large: 110-130 mm; XX-Large: 120-140 mm	PASS
		Finger thickness: ≥0.05 mm	PASS
		Palm thickness: ≥0.05 mm	PASS
		Cuff thickness: ≥0.05 mm	PASS
Physical Properties	ASTM D6319	AQL 4.0; Before Aging: Tensile Strength: ≥14 MPa, Ultimate elongation: ≥500%; After Aging: Tensile Strength: ≥14 MPa, Ultimate elongation: ≥400%	PASS
Freedom from Pinholes	ASTM D6319, ASTM D5151	AQL 2.5%; No leakage	PASS
Residual Powder	ASTM D6124, ASTM D6319	≤ 2 mg / glove	PASS
Permeation by Chemotherapy Drugs	ASTM D6978	No breakthrough detected up to 240 minutes for: Cisplatin (1 mg/ml), Cyclophosphamide (20 mg/ml), Dacarbazine (10 mg/ml), Doxorubicin HCl (2 mg/ml), Etoposide (20 mg/ml), Fluorouracil (50 mg/ml), Ifosfamide (50 mg/ml), Mitoxantrone HCl (2 mg/ml), Paclitaxel (6 mg/ml), Vincristine Sulfate (1 mg/ml). Caution (Breakthrough < 60 min): Carmustine (3.3 mg/ml – no breakthrough up to 35.1 minutes). Caution (Breakthrough < 120 min): Thiotepa (10 mg/ml – no breakthrough up to 107.2 minutes). Warning: Not for use with Carmustine, Thiotepa.	PASS
Permeation by Hazardous Drugs (Opioids)	ASTM D6978 (Implied)	No breakthrough detected up to 240 minutes for: Fentanyl Citrate Injection (50 mcg/5 ml), Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution.	PASS
Test for Irritation	ISO 10993, Part 23	No dermal irritation reactions	PASS
Test for Acute Systemic Toxicity	ISO 10993, Part 11	Under the conditions of the study, the device extract does not induce acute systemic toxicity response.	PASS
Test for Skin Sensitization	ISO 10993, Part 10	No dermal reactions indicative of delayed contact hypersensitivity.	PASS

Study Details (Based on available information)

Sample sizes used for the test set and the data provenance:
- The document does not explicitly state the exact sample sizes for each specific test (e.g., number of gloves tested for pinholes, number of samples per drug for permeation). However, all tests are performed according to recognized ASTM and ISO standards, which typically specify statistically significant sample sizes for their respective tests.
- Data Provenance: The studies are non-clinical (laboratory-based) performance and biocompatibility tests conducted by the manufacturer (O&M Halyard, Inc.). The country of origin of the data is not specified but is implicitly associated with the manufacturer's testing facilities. The studies are prospective in nature, meaning they were designed and executed to evaluate the device's performance against defined criteria.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a non-clinical device that relies on a pass/fail outcome against established engineering and biocompatibility standards, not expert interpretation of medical images or biological samples. The "ground truth" is determined by the results of the specified physical and chemical tests.
Adjudication method for the test set:
- Not applicable. As this involves objective, quantifiable laboratory tests against defined numerical criteria (e.g., specific tensile strength, elongation percentages, lack of leakage, breakthrough times), there is no need for expert adjudication. The results are directly compared to the acceptance criteria.
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 a medical examination glove, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed, and thus no effect size for AI assistance is relevant.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical product (a glove), not an algorithm or software. Its performance is evaluated through physical and chemical testing.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is based on established industry standards and regulatory requirements (e.g., ASTM and ISO standards). For example, for "Freedom from Pinholes," the ground truth is "no leakage" at an AQL 2.5%, determined by empirical testing methods defined in ASTM D5151. For chemotherapy drug permeation, the ground truth is the measured breakthrough time for each specific drug, evaluated against a performance threshold (e.g., >240 minutes for no breakthrough).
The sample size for the training set:
- Not applicable. This is a physical medical device, not a machine learning or AI model that requires a training set.
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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