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Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) is a disposable device intended for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 (2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.

The following chemotherapy drugs and concentration had NO breakthrough detected up to 240 minutes:

Bleomycin Sulfate (15.0 mg/ml)
Busulfan (6.0 mg/ml)
Carboplatin (10.0 mg/ml)
Cisplatin (1.0 mg/ml)
Cyclophosphamide (20.0 mg/ml)
Cytarabine (100.0 mg/ml)
Dacarbazine (10.0 mg/ml)
Daunorubicin HCl (5.0 mg/ml)
Docetaxel (10.0 mg/ml)
Doxorubicin HCl (2.0 mg/ml)
Epirubicin HCl (2.0 mg/ml)
Etoposide (20.0 mg/ml)
Fludarabine (25.0 mg/ml)
Fluorouracil (50.0 mg/ml)
Gemcitabine (38.0 mg/ml)
Idarubicin HCl (1.0 mg/ml)
Ifosfamide (50.0 mg/ml)
Irinotecan (20.0 mg/ml)
Mechlorethamine HCl (1.0 mg/ml)
Melphalan (5.0 mg/ml)
Methotrexate (25.0 mg/ml)
Mitomycin C (0.5 mg/ml)
Mitoxantrone HCl (2.0 mg/ml)
Paclitaxel (6.0 mg/ml)
Rituximab (10.0 mg/ml)
Trisenox (1.0 mg/ml)
Vincristine Sulfate (1.0 mg/ml)

The following chemotherapy drugs have low permeation times: Carmustine (3.3 mg/ml) : 33.8 minutes Thiotepa (10.0 mg/ml) : 128.1 minutes

Warning: Not for Use with: Carmustine, Thiotepa

Device Description

Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) is a Class I, patient examination gloves bearing the product codes LZA, LZC, OPJ (21CFR880.6250). They meet all the current specifications listed under the ASTM D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application and also complies with requirements for Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs as per ASTM D6978-05 (2019). They are made from Nitrile (NBR). These gloves are blue in color and are powder free. The product is non-sterile, fingertip textured, ambidextrous with beaded cuff and single use only.

Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) with sizes Medium, Large, X-Large and XX-Large are included in the submission.

AI/ML Overview

The provided text describes the acceptance criteria and performance of the Nephron Nitrile Powder-Free Nitrile Examination Gloves.

Here's the requested information:

1. A table of acceptance criteria and the reported device performance

Test Method (Standard)	Purpose	Acceptance Criteria	Reported Device Performance
ASTM D6319-19 (Dimensions - Length)	To determine the length of the gloves	Medium: 230 mm min
Large: 230 mm min
X-Large: 230 mm min
XX-Large: 230 mm min	Medium: 235 mm
Large: 237 mm
X-Large: 250 mm
XX-Large: 238 mm
ASTM D6319-19 (Dimensions - Width)	To determine the width of the gloves	Medium: 95+/-10 mm
Large: 110+/-10 mm
X-Large: 120+/-10 mm
XX-Large: 130+/-10 mm	Medium: 95 mm
Large: 113 mm
X-Large: 121 mm
XX-Large: 129 mm
ASTM D6319-19 (Thickness)	To determine the thickness of the gloves	Palm: 0.05 mm min for all sizes
Finger: 0.05 mm min for all sizes	Size Palm (Avg value) Finger (Avg value)
Medium 0.077 mm 0.111 mm
Large 0.106 mm 0.109 mm
X-Large 0.089 mm 0.115 mm
XX-Large 0.113 mm 0.107 mm
ASTM D6319-19 (Physical Properties - Tensile Strength)	To determine the physical properties - Tensile strength	Before Ageing Tensile Strength: 14MPa min for all sizes
After Ageing Tensile Strength: 14MPa min for all sizes	Size Before ageing After ageing
Medium 34.0 MPa 37.3 MPa
ASTM D6319-19 (Physical Properties - Ultimate Elongation)	To determine the physical properties - Ultimate Elongation	Before Ageing Ultimate Elongation: 500% min for all sizes
After Ageing Ultimate Elongation: 400% min for all sizes	Size Before ageing After ageing
Medium 542% 503%
ASTM D5151-19 (Freedom from holes)	To determine the holes in the gloves	AQL 2.5	Gloves Passes AQL 2.5
ASTM D6124-06 (Residual Powder)	To determine the residual powder in the gloves	≤ 2 mg/glove	Medium: 0.3516 mg/glove
ASTM D6978-05 (Chemotherapy Drugs Permeation)	To determine the breakthrough detection time of chemotherapy drugs	For listed drugs (e.g., Bleomycin Sulfate, Busulfan, Carboplatin, Cisplatin, Cyclophosphamide, Cytarabine, Dacarbazine, Daunorubicin HCl, Docetaxel, Doxorubicin HCl, Epirubicin HCl, Etoposide, Fludarabine, Fluorouracil, Gemcitabine, Idarubicin HCl, Ifosfamide, Irinotecan, Mechlorethamine HCl, Melphalan, Methotrexate, Mitomycin C, Mitoxantrone HCl, Paclitaxel, Rituximab, Trisenox, Vincristine Sulfate): >240 Minutes.
Carmustine (3.3 mg/ml): Not specified as a pass/fail criterion, but a low permeation time is noted.
Thiotepa (10.0 mg/ml): Not specified as a pass/fail criterion, but a low permeation time is noted.	For all 28 listed chemotherapy drugs, the breakthrough detection time was >240 Minutes.
Carmustine (3.3 mg/ml) : 33.8 minutes
Thiotepa (10.0 mg/ml) : 128.1 minutes
ISO 10993-23 (Primary Skin Irritation)	To evaluate the local dermal irritation in rabbits	Under the condition of study not an irritant	Under the conditions of the study, the test article met the requirements of the test.
ISO 10993-10 (Dermal Sensitization)	To evaluate the skin sensitization in Guinea pigs	Under the conditions of the study, not a sensitizer	Under the conditions of the study, the test article was not considered a sensitizer.
ISO 10993-5 (In Vitro Cytotoxicity)	To determine the potential to cause cytotoxicity	Under the conditions of the study, non-cytotoxic	The undiluted test article extract and 50% test article extract dilution did not meet the requirements of the test and the 25%, 12.5%, 6.25%, and 3.13% test article extract dilutions met the requirements of the test. The cytotoxic concern was addressed via acute systemic toxicity testing. (This result indicates some cytotoxicity at higher concentrations but was mitigated by systemic toxicity testing).
ISO 10993-11 (Acute Systemic Toxicity)	To evaluate the acute systemic toxicity in mice	Under the conditions of study, the device extracts do not pose a systemic toxicity concern	Under the conditions of study, there was no mortality or evidence of systemic toxicity.

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 does not explicitly state the sample sizes for each test in the level of detail (e.g., number of gloves tested for each specific property or chemotherapy drug). It only refers to compliance with the standards (e.g., AQL 2.5 for freedom from holes).

The data provenance (country of origin, retrospective/prospective) is not mentioned. These are bench tests, not human trials or medical imaging data.

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 information is not applicable. The document describes bench testing of physical and chemical properties of gloves, not expert interpretation of medical images or clinical data.

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

This information is not applicable. The tests are laboratory-based and follow standardized testing protocols, which do not typically involve adjudication methods like those used for expert review of clinical cases.

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

This information is not applicable. The document describes the testing of medical examination gloves, which are physical products, not AI systems or medical imaging devices. Therefore, MRMC studies and AI assistance are irrelevant.

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

This information is not applicable. The document describes the testing of medical examination gloves, which are physical products, not algorithms.

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

The "ground truth" for these tests is defined by the technical specifications and performance requirements outlined in the referenced ASTM and ISO standards. For example:

Physical properties (length, width, thickness, tensile strength, elongation) are measured objectively against defined numerical limits.
Freedom from holes is assessed against an Acceptable Quality Limit (AQL), a statistical measure.
Resistance to chemotherapy drugs is measured by detecting breakthrough time using specific analytical methods defined in ASTM D6978.
Biocompatibility tests (irritation, sensitization, cytotoxicity, systemic toxicity) are assessed by observing biological responses in animal models or in vitro systems against established criteria for non-irritancy, non-sensitization, and non-toxicity according to ISO standards.

Essentially, the "ground truth" reflects compliance with regulatory and industry standards for glove performance and safety.

8. The sample size for the training set

This information is not applicable, as this is not a machine learning model.

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

This information is not applicable, as this is not a machine learning model.

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