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The Nitrile Powder Free Examination Glove (Blue) with Low Dermatitis Potential Claim is a disposable device intended for Medical purpose that is worn on the examiner's hands or finger to prevent contamination patient and examiner In addition these gloves was tested for use with Chemotherapy drugs in accordance with ASTM D6978-05 standards, Practice for assessment of medical glove to Permeation by chemotherapy Drugs.
A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner .In addition these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 standards ,Practice for assessment of Medical Glove to Permeation by chemotherapy Drugs . It is for overthe-counter use.

Device Description

The subject device in this 510(k) Notification is Blue Nitrile Examination gloves, with claiming, this product contain Low Dermatitis Potential Claim and tested for use with Chemotherapy drugs. The subject device is a patient examination glove made from nitrile compound, Blue color, powder free and non sterile (Per 21 CFR 880.6250, class I). The device meets all the specifications in ASTM D6319-10, Standard specification for Nitrile Examination Gloves.

AI/ML Overview

This document outlines the acceptance criteria and supporting studies for the "Powder Free Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for Use with Chemotherapy Drugs" (K152542).

1. Table of Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria	Reported Device Performance (K152542)
Product Code	LZA, LZC	LZA, LZC
Intended Use	A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. The device is for over-the-counter use.	Meets criteria. Additionally, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978-05 standards, Practice for assessment of medical glove to Permeation by chemotherapy Drugs.
Material Use	Nitrile compound	Nitrile compound
Color	Blue	Blue
Sterility/Single Used	Non sterile, Single used	Non sterile, Single used
Dimensions (Overall Length, Width, Thickness)	Overall Length (mm): Min 270mmWidth (±5mm): Size S = 85mm, Size M = 95mm, Size L = 105mm, Size XL = 115mmThickness at Palm (mm): Min; 0.10 mmThickness at Finger Tip (mm): Min 0.10 mm	Meets ASTM D6319-10 (Standard Specification for Nitrile Examination Gloves)
Biological Evaluation - Primary Skin Irritation	Test article should be a non-irritant.	Under the conditions of this study, the test article was a non-irritant.
Physical Properties (Before Ageing)	Tensile Strength (MPa): >= 14minUltimate Elongation (%): >= 500min	Meets ASTM D6319-10
Physical Properties (After Aging)	After Aging at 70°C for 168 hrs @ 100°C for 22 hrs:Tensile Strength (MPa): >= 14minUltimate Elongation (%): >= 400min	Meets ASTM D6319-10
Biological Evaluation - Dermal Sensitization Assay	Test article should be a non-sensitizer.	Under the conditions of this study, the test article was a non-sensitizer.
Resistance against Chemotherapy Drugs	Minimum Breakthrough Detection time in minutes (0.01 µg/cm²/minute) based on ASTM D6978-05 for specified drugs.	Carmustine (BCNU) (3.3mg/ml): 20.1 minutesCyclophosphamide (20mg/ml): > 240 minutesCisplatin (1.0mg/ml): > 240 minutesDoxorubicin Hydrochloride (2 mg/ml): > 240 minutesEtoposide (20mg/ml): > 240 minutesFluorouracil (50mg/ml): > 240 minutesMethotrexate (25mg/ml): > 240 minutesPaclitaxel (6mg/ml): > 240 minutesThiotepa (10mg/ml): 50.6 minutes
Freedom from Pinholes	AQL 2.5, Inspection Level G-1	Meets ASTM D5151-06
Residual Powder	< 2.0 mg/pc	Meets ASTM D6124-06
Low Dermatitis Potential Claim	No clinical evidence of residual chemical additives that may induce Type IV allergy in human subjects (based on Modified Draize 95 test).	No clinical evidence presence of residual chemical additives that may induce Type IV allergy in human subject.

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

The document details testing for various attributes, with specific sample sizes and testing methods mentioned.

Mechanical Properties (Dimensions, Physical Properties, Freedom from Pin-holes, Residual Powder): The testing was conducted according to ASTM D6319-10, ASTM D5151-06, and ASTM D6124-06. These standards typically specify sampling plans (e.g., AQL levels for pinholes) which define the sample sizes. The document states "Gloves meet all the specification listed in ASTM D 6319-10" and "Meets ASTM D5151-06" and "Meets ASTM D6124-06", indicating adherence to these sampling requirements. Specific numerical sample sizes for each test are not explicitly provided in the summary, but are implied by reference to the ASTM standards.
Resistance Against Chemotherapy Drugs: Tested in accordance with ASTM D6978-05. The specific sample size used for this test is not explicitly stated in the provided text.
Low Dermatitis Potential Claim (Skin Sensitization):
- Sample Size: Initial stage with 30 human subjects, followed by an additional number of subjects to reach a total of a minimum of 205 individuals.
- Data Provenance: The study was conducted on "non sensitized adult human subjects, who reasonably reflect the general user population in the US." This implies the data is prospective and representative of the US population, although the study itself was likely conducted by the manufacturer (Riverstone Resources Sdn. Bhd. in Malaysia) or a contract research organization.
Primary Skin Irritation: The specific sample size for this test is not explicitly stated but is also an in-vivo biological evaluation performed under ISO 10993-10:2010.

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

For physical and chemical properties (e.g., dimensions, tensile strength, chemotherapy drug permeation, pinholes, residual powder): The ground truth is established by objective, standardized laboratory tests according to recognized ASTM and ISO standards. These do not typically involve human "experts" in the way clinical studies do. The "ground truth" is the quantitative measurement or qualitative assessment (e.g., pass/fail) determined by the test method.
For Low Dermatitis Potential Claim (Modified Draize 95 test): This is a human subject study. The nature of the "ground truth" is the observed skin reaction (or lack thereof) in the human subjects. The qualification of individuals assessing these reactions (e.g., dermatologists) is not specified in the document but would typically involve trained medical professionals or researchers.

4. Adjudication Method for the Test Set

For physical and chemical properties: Adjudication is not applicable in the traditional sense. The results are objective measurements against predefined criteria.
For Low Dermatitis Potential Claim (Modified Draize 95 test): The document states that "The study completed on 205 non sensitized adult human subjects...gave all negative results. There was no clinical evidence of the presence of residual chemical additives..." This implies a direct observation and interpretation by the study's clinical staff. No specific adjudication method like "2+1" or "3+1" is mentioned for conflicting expert opinions, as the result was consistently negative for all subjects.

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

No, an MRMC comparative effectiveness study was not done. This device is a medical glove, and the studies described are performance and biocompatibility assessments, not diagnostic imaging or clinical decision support tools that would typically involve human readers or AI assistance in the way an MRMC study is designed.

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

Not applicable. This device is a physical product (a glove), not an algorithm or a software device. The concept of "standalone performance" for an algorithm without human involvement does not apply here. The performance is the inherent performance of the glove itself.

7. The Type of Ground Truth Used

Physical/Chemical Properties: Standardized measurements and assessments from laboratory testing against established specifications (e.g., ASTM standards). This is objective laboratory data.
Chemotherapy Drug Permeation: Breakthrough detection time measured in accordance with ASTM D6978-05. This is objective laboratory data.
Primary Skin Irritation and Dermal Sensitization: In-vivo biological response observed in animal studies (for general biocompatibility, although human studies were done for sensitization). For the Low Dermatitis Potential Claim, the ground truth is the clinical outcome (presence or absence of irritation/sensitization) observed in human subjects.

8. The Sample Size for the Training Set

Not applicable. This document describes the performance of a manufactured medical device (glove), not an AI or machine learning model. Therefore, there is no "training set" in the context of algorithm development. The "training" for such a product would involve manufacturing process controls and quality assurance, which are not detailed as a "training set" in this context.

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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