(66 days)
HEALTH + AID @ PREMIUM Powderfree Latex Examination Glove is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contanination between the health care personnel and the patient.
HEALTH + AID ® PREMIUM Powder Free Latex Examination Gloves meet the current specifications listed under the ASTM Specification D 3578 - 95, Standard Specification for Rubber Examination Gloves. They are natural white in colour and are powder free.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the "HEALTH + AID ® PREMIUM POWDER FREE LATEX EXAMINATION GLOVES":
This document is a 510(k) summary for a medical device (examination gloves), which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed performance study with comprehensive acceptance criteria and statistical analysis of an AI algorithm. Therefore, many of the requested points related to AI performance, expert ground truth, adjudication, MRMC studies, and training sets are not applicable to this type of submission.
The "acceptance criteria" for this device are the established specifications for latex examination gloves, primarily defined by the ASTM D 3578-95 standard and FDA regulations.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ASTM D 3578-95 & 21 CFR 800.20) | Reported Device Performance |
|---|---|
| Physical Properties (e.g., Tensile Strength, Elongation, Dimensions, Freedom from Holes) | "Gloves meet all the current specifications listed under the ASTM Specification D 3578-95, Standard Specification for Rubber Examination Gloves." |
| Biocompatibility (e.g., Primary Skin Irritation, Delayed Contact Sensitization) | "Primary skin irritation testing in the rabbit and delayed contact sensitization testing in the guinea pig indicate no irritation or sensitization." |
| Powder/Starch Content | "Final product is negative for the test for presence of starch using the USP iodine test." |
| Protein Content | "With Protein Labeling Claim (50 Micrograms or Less)" / "50 MICROGRAMS OR LESS OF TOTAL EXTRACTABLE PROTEIN PER GRAM." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of an AI algorithm's performance evaluation. Instead, it refers to general product testing in accordance with established standards.
- Sample Size: Not explicitly stated for specific tests. ASTM D 3578-95 and 21 CFR 800.20 would dictate the sampling plans and lot sizes required for various tests (e.g., visual inspection for holes, physical properties, bioburden).
- Data Provenance: The testing was performed on the manufactured "HEALTH + AID ® PREMIUM POWDER FREE LATEX EXAMINATION GLOVES" themselves, presumably at the manufacturer's facility (M.R.G. INDUSTRIES SDN. BIID., Malaysia) or by a contracted lab. This would be considered prospective for the specific batches tested to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This concept is not applicable to this device and submission. "Ground truth" in this context refers to established laboratory testing methods and regulatory standards, not expert consensus on medical images or clinical observations. The "experts" would be the laboratory technicians performing the specified tests according to ASTM and FDA protocols, who are qualified in those specific testing methodologies.
4. Adjudication Method for the Test Set
This concept is not applicable. Adjudication refers to resolving disagreements among experts, which isn't relevant for standardized laboratory tests against predefined specifications.
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 is not applicable as this is not an AI-powered diagnostic or assistive device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable as this is not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- Standardized Laboratory Test Results: Measurements of physical properties (tensile strength, elongation, etc.), chemical tests (starch presence, protein content), and biological tests (skin irritation, sensitization) performed according to internationally recognized standards like ASTM D 3578-95 and specified methodologies in 21 CFR 800.20.
- Predicate Device Equivalence: The primary "ground truth" for regulatory acceptance is demonstrating that the device is "substantially equivalent" to an already legally marketed device (Class 1 patient examination glove 80LYY which meets ASTM D 3578-95).
8. The Sample Size for the Training Set
This is not applicable as this is not an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as this is not an AI algorithm.
§ 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.