(62 days)
AMBIDERM Powder Free Latex Examination Glove (Black Colored), polymer coated, with a protein labeling claim is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.
Ambiderm Powder Free Latex Examination Gloves with Protein Labeling Claim meet the current specifications listed under the ASTM specifications D 3578-99 standard specification for rubber examination gloves. They are black in color.
The provided text describes the 510(k) summary for "AMBIDERM POWDER FREE (COLORED) LATEX EXAMINATION GLOVES WITH PROTEIN CLAIMS OF 50 MICROGRAMS OR LESS PER GRAMS". This document focuses on the regulatory clearance for general-purpose medical gloves and does not involve AI, image analysis, or complex medical diagnostic performance. Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable in the context of this medical device.
However, I can extract the relevant information regarding acceptance criteria and the methods used to demonstrate compliance for these examination gloves.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| ASTM D 3578-99 (Standard Specification for Rubber Examination Gloves) | Meets all current specifications listed under ASTM D 3578-99 |
| 21 CFR 800.20 (Puncture Resistance, Force at Break, etc.) | Testing performed as per 21 CFR 800.20. Gloves meet all current specifications. |
| Primary Skin Irritation (rabbit) | No irritation indicated |
| Delayed Contact Sensitization (guinea pig) | No sensitization indicated |
| Test for Presence of Starch (USP iodine test) | Negative for the test |
| Protein Claims (50 micrograms or less per gram) | Meets the current specifications for protein claims |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes used for testing according to ASTM D 3578-99 or 21 CFR 800.20 for the specific device being submitted. These standards typically define sampling plans. The data provenance is not explicitly stated in terms of country of origin, but the testing was conducted to U.S. regulatory standards (ASTM and FDA). The implication is that these were non-clinical, лабораторные испытания directly related to the product being submitted. It's a "prospective" evaluation in the sense that the new device was manufactured and then tested to meet established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This concept is not applicable here. "Ground truth" in this context refers to the defined specifications and performance requirements set by the ASTM standard and FDA regulations. The "experts" are the consensus bodies that established these standards, and the testing laboratories or personnel simply verify compliance against these objective metrics. There isn't an "expert adjudication" process like there would be for diagnostic imaging.
4. Adjudication Method for the Test Set:
Not applicable. Compliance is determined by direct measurement against objective criteria defined in the ASTM standards and FDA regulations, not by expert consensus or adjudication.
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 an examination glove, not an AI or diagnostic imaging device that involves human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is not an algorithm. Its performance is evaluated through physical and material property testing.
7. The Type of Ground Truth Used:
The ground truth used is based on:
- Standard Specifications: ASTM D 3578-99 (physical properties like dimensions, tensile strength, elongation, freedom from holes).
- Regulatory Requirements: 21 CFR 800.20 (biocompatibility, protein claims).
- Laboratory Tests: Primary skin irritation in rabbits, delayed contact sensitization in guinea pigs, USP iodine test for starch presence.
8. The Sample Size for the Training Set:
Not applicable. This device is a physical product (gloves), not an AI algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
§ 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.