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A 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.

Device Description

The Dermagrip powder free blue nitrile patient examination glove is manufactured from synthetic rubber latex. Inner surface of gloves undergo surface treatment process to produce a smooth surface that assists the user in donning the qloves with ease without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e. can be worn on right hand or left hand.

AI/ML Overview

This document is a 510(k) summary for the Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile. It provides information about the device's characteristics and how it meets acceptance criteria, primarily through comparison to established standards and a predicate device.

Here's a breakdown of the requested information based on the provided text:

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

CHARACTERISTICS	STANDARDS	Acceptance Criteria (from Standards)	Reported Device Performance (Current)
Dimensions	ASTM D6319-10	Meets ASTM D6319-10 requirements	Meets
Physical Properties	ASTM D6319-10	Meets ASTM D6319-10 requirements	Meets
Thickness	ASTM D6319-10	Meets ASTM D6319-10 requirements	Meets (Note: Current device is thinner than predicate but still meets standard)
Powder Free	ASTM D6124-06	≤ 2 mg/glove	Meets (≤ 2 mg/glove)
Biocompatibility (Primary Skin Irritation)	ISO 10993-10:2010(E) & Consumer Product Safety Commission, Title 16, Chapter II, Part 1500	Passes (Not a primary skin irritant)	Passes (Not a primary skin irritant). There was no erythema or oedema noted on test sites after (24±2), (48±2) and (72±2) hours. The Primary Irritation Index (PII) was "0".
Biocompatibility (Dermal Sensitization)	ISO 10993-10:2010(E) & Consumer Product Safety Commission, Title 16, Chapter II, Part 1500.3(c)(4)	Passes (Not a contact sensitizer)	Passes (Not a contact sensitizer). There was no positive allergic reaction observed during the challenge phase at (0±2), (24±2) and (48±2) hours in animals treated with the test material and negative control.
Watertight (1000ml)	ASTM D5151-06	Passes (as per standard)	Passes
Intended use	N/A (Descriptive)	Disposable device for medical purposes to prevent contamination between patient and examiner.	A 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.
Material	ASTM D6319-10	Nitrile	Nitrile
Color	N/A (Descriptive)	Blue	Blue
Texture	N/A (Descriptive)	Finger textured	Finger textured
Size	Medical Glove Guidance Manual - Labeling	Small, Medium, Large, Extra Large (for predicate)	Extra Small, Small, Medium, Large, Extra Large
Single Use	Medical Glove Guidance Manual - Labeling	Single use	Single use

2. Sample sizes 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 used for each specific test (e.g., for biocompatibility, watertightness, etc.). It only indicates that the device's performance "Meets" the respective standards. The provenance of the data is not specified in terms of country of origin or whether it was retrospective or prospective, beyond acknowledging that the manufacturer (WRP Asia Pacific Sdn Bhd) is located in Malaysia.

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 type of information is not applicable to the device described. The device is a patient examination glove, and its performance is assessed against established engineering and biocompatibility standards (ASTM, ISO), not through expert interpretation of medical images or clinical outcomes that require "ground truth" established by medical experts in a diagnostic context. The "ground truth" here is the pass/fail criteria defined by the standards.

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

Not applicable. As explained above, the assessment is against predefined technical and biological standards, not through adjudication of expert opinions on a test set.

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 medical glove, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study and effects on human readers are irrelevant.

6. 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.

7. 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. For example:

Dimensions, Physical Properties, Thickness: Defined by ASTM D6319-10.
Powder Free: Defined by ASTM D6124-06 (≤ 2 mg/glove).
Biocompatibility: Defined by ISO 10993-10:2010(E) and Consumer Product Safety Commission regulations (absence of primary skin irritation, absence of dermal sensitization).
Watertight: Defined by ASTM D5151-06 (passing the water leak test).
Intended Use, Material, Color, Texture, Size, Single Use: Compliance with descriptive criteria or labeling guidance.

These standards provide objective, measurable criteria for the device's performance.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set. Its development and testing follow established engineering and manufacturing quality control processes.

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

Not applicable, as no training set is used for this type of device.

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