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The Purism Non-sterile Powder Free Nitrile Examination Gloves is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Device Description

The Purism Non-sterile Powder Free Nitrile Examination Gloves are a non-sterile, powder free, single use, disposable item. The gloves are made from nitrile compound and are blue in color. The gloves are ambidextrous and offered in Small, Medium, Large and X-Large sizes.

AI/ML Overview

The provided document describes the FDA's 510(k) clearance for the Purism Non-sterile Powder Free Nitrile Examination Gloves. It outlines the non-clinical tests performed to demonstrate that the device meets acceptance criteria.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

Test Method	Purpose	Acceptance Criteria	Reported Device Performance	Pass/Fail
ASTM D6319-19 (Dimensions)	To determine glove length	Min Length (mm): Size S: 230, Size M: 230, Size L: 230, Size XL: 230	Avg Min Length (mm): Size S: 236, Size M: 239, Size L: 241, Size XL: 238	Pass
	To determine glove palm width	Palm Width (mm): Size S: 80±10, Size M: 95±10, Size L: 110±10, Size XL: ≥110	Avg Palm Width (mm): Size S: 84, Size M: 95, Size L: 103, Size XL: 111	Pass
	To determine glove finger thickness	Finger Thickness (mm): Size S: 0.100±0.02, Size M: 0.100±0.02, Size L: 0.100±0.02, Size XL: 0.100±0.02	Avg Finger Thickness (mm): Size S: 0.096, Size M: 0.111, Size L: 0.108, Size XL: 0.111	Pass
	To determine glove palm thickness	Palm Thickness (mm): Size S: 0.060±0.02, Size M: 0.060±0.02, Size L: 0.060±0.02, Size XL: 0.060±0.02	Avg Palm Thickness (mm): Size S: 0.058, Size M: 0.066, Size L: 0.074, Size XL: 0.080	Pass
ASTM D6319-19 (Physical Properties)	To determine glove physical properties before and after ageing	Before Ageing: Tensile Strength min 14 MPa, Ultimate Elongation min 500%	Before Ageing: Tensile Strength min 18.0 MPa, Ultimate Elongation min 694%	Pass
		After Ageing: Tensile Strength min 14 MPa, Ultimate Elongation min 400%	After Ageing: Tensile Strength min 18.2 MPa, Ultimate Elongation min 664%	Pass
ASTM D5151-19	To detect holes and check for water leaks	As per ISO 2859-1. GI Level II, Lot Size 3000, Sample Size 125, AQL 1.5, Ac=5, Re=6	Pass at AQL 1.5	Pass
ASTM D6124	To determine residual powder	≤2 mg/glove	0.06 mg/glove	Pass
ISO 10993-10:2010 (Primary Skin Irritation)	To determine if device is a skin irritant	The device must be a non-irritant	Under the study conditions not an irritant	Pass
ISO 10993-10:2010 (Dermal Sensitization)	To determine if device is a dermal sensitizer	The device must be a non-sensitizer	Under the study conditions not a sensitizer	Pass
ISO 10993-5:2009 (In vitro Cytotoxicity)	To determine if device extract is cytotoxic	The device must be non-cytotoxic	Under the study conditions cytotoxic	Fail
ISO 10993-11:2017 (Acute Systemic Toxicity)	To determine if device induces systemic toxicity	The device must not induce systemic toxicity	Under the study conditions did not induce systemic toxicity	Pass

Note on Cytotoxicity: While the device showed cytotoxic properties in the in vitro test, the document states that additional acute systemic toxicity testing (ISO 10993-11:2017) supported that the device was not systemically toxic. The primary skin irritation and dermal sensitization tests also indicated the device was not an irritant or skin sensitizer. This suggests that the manufacturer provided sufficient evidence to mitigate concerns arising from the in vitro cytotoxicity result in the context of the device's intended use.

2. Sample size used for the test set and the data provenance

The document specifies "Sample Size 125" for the ASTM D5151-19 (Freedom from Holes) test, which is based on ISO 2859-1, GI Level II, and Lot Size 3000. For other tests like dimensions, physical properties, and biocompatibility, specific sample sizes are not explicitly stated in this summary, but the results are reported as average values, indicating that multiple samples were tested.

The provenance of the data (country of origin, retrospective/prospective) is not explicitly stated for each test. However, the manufacturer is "Dezhou Purism Medical Technology Co., Ltd." located in China, suggesting the testing was likely conducted in or overseen from China. The studies are non-clinical (laboratory-based) tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The tests performed are objective, standardized laboratory tests according to ASTM and ISO standards for medical gloves. They do not involve expert interpretation or ground truth establishment in the way clinical studies with human assessors would.

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

Not applicable. As these are objective laboratory tests, there is no adjudication method involved. The results are quantitative measurements against predefined criteria.

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

Not applicable. This device is a nitrile examination glove, not an AI-powered diagnostic tool, and therefore, MRMC studies are not relevant.

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

Not applicable. This device is a physical medical glove. The performance evaluation is based on its material properties and manufacturing quality, not an algorithm.

7. The type of ground truth used

The "ground truth" for the performance tests conducted (dimensions, physical properties, freedom from holes, residual powder, biocompatibility) is established by adherence to recognized international standards (ASTM D6319-19, ASTM D5151-19, ASTM D6124, ISO 10993-10:2010, ISO 10993-5:2009, ISO 10993-11:2017) and their specified acceptance criteria. These standards define the measurable properties that a glove must meet for its intended use.

8. The sample size for the training set

Not applicable. This device is a physical product and does not involve AI or machine learning, thus there is no "training set."

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

Not applicable. There is no training set for this device.

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