(62 days)
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.
Dental Latex Examination Gloves are formulated using natural rubber latex and offered non-sterile.
This document describes the safety and effectiveness summary for Allegiance Dental Latex Examination Gloves with Protein Labeling Claim.
Here's an analysis of the provided text, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Primary Skin Irritation | No potential for irritation | Gloves do not display any potential for irritation. |
| Systemic Toxicity | No toxic reactions to acute application | Gloves do not elicit any toxic reactions to acute application. |
| Intracutaneous Reactivity | No reactivity | Gloves show no reactivity. |
| Hemocompatibility | No lysis | Gloves are hemocompatible exhibiting no lysis. |
| Guinea Pig Maximization | No potential for irritation | Gloves do not display any potential for irritation. |
| Ultimate Elongation & Tensile Strength | Meet or exceed requirements for rubber examination gloves per ASTM D3578-99 | Gloves meet or exceed requirements for rubber examination gloves per ASTM D3578-99. |
| Barrier Defects | Meet or exceed requirements per 21 CFR §800.20, AQL = 4.0 | Gloves meet or exceed requirements per 21 CFR §800.20, AQL = 4.0. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample sizes used for each of the listed tests (e.g., number of gloves tested for barrier defects, number of animals for skin irritation tests).
The data provenance is not explicitly stated as "country of origin." However, the manufacturer is "Allegiance Healthcare Sdn. Bhd. Plot 87. Kampung Jawa 11900 Bayan Lepas Penang, West Malaysia." The summary was prepared for the FDA in the USA. The tests themselves are scientific and generally accepted internationally. The text does not explicitly state if the studies were retrospective or prospective, but given the nature of product testing for regulatory submission, they would typically be prospective studies designed to assess product performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the text. The tests listed are for material properties and biological responses, rather than interpretation of diagnostic images or clinical scenarios that would typically require expert consensus as "ground truth." The "ground truth" for these tests are objective measurements or observable biological reactions.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. Adjudication methods like "2+1" or "3+1" are typically used when multiple human readers are interpreting data or making diagnoses (e.g., in medical image analysis). For material and biological testing, the results are usually objectively measured or observed, often against established standards.
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. This document describes the safety and effectiveness of a physical medical device (examination gloves), not an artificial intelligence (AI) system or diagnostic tool that would involve human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. This document is about a physical medical device.
7. The Type of Ground Truth Used
The ground truth used for these tests is based on:
- Objective measurements and scientific standards: For tests like Ultimate Elongation & Tensile Strength (against ASTM D3578-99) and Barrier Defects (against 21 CFR §800.20, AQL = 4.0).
- Observable biological responses: For tests like Primary Skin Irritation, Systemic Toxicity, Intracutaneous Reactivity, Hemocompatibility, and Guinea Pig Maximization, where the "ground truth" is the presence or absence of a specific adverse biological reaction as assessed according to established scientific protocols.
8. The Sample Size for the Training Set
This information is not applicable/not provided. The concept of a "training set" is relevant to machine learning or AI development. For a physical device like examination gloves, the manufacturing process might involve process control parameters that are "trained" or optimized, but there isn't a "training set" of data in the AI sense. The text describes product testing to meet regulatory standards.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/not provided for the reasons stated in point 8.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered 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. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.