(24 days)
HEALTH + AID® PREMIUM Pre-powdered 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 contamination between the health care personnel and the patient.
100mcg/gm or less total water extractable protein per gram
HEALTH + AID® PREMIUM Pre-powdered Latex Examination Gloves meet the current specifications listed under the ASTM Specification D 3578 - 95, Standard Specification for Rubber Examination Gloves. They are
This document describes the 510(k) summary for HEALTH + AID® PREMIUM Pre-powdered Latex Examination Gloves.
Here's an analysis of the provided text with respect to your specific questions:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meets ASTM D 3578-95, Standard Specification for Rubber Examination Gloves | Gloved meet all the current specifications listed under the ASTM Specification D 3578-95, Standard Specification for Rubber Examination Gloves. |
| Meets 21 CFR 800.20 | Gloves meet all the current specifications listed under 21 CFR 800.20 |
| Primary skin irritation testing in the rabbit | No irritation |
| Delayed contact sensitization testing in the guinea pig | No sensitization |
| Total Water Extractable Protein | 100mcg/gm or less total water extractable protein per gram (this is an indication for use, not specifically an acceptance criteria for performance against the predicate, but it is a claim being made for the device) |
2. Sample size(s) 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 testing. It refers to "Testing is performed as per ASTM D 3578-95 and 21 CFR 800.20." These standards, particularly ASTM D 3578-95, would define the sampling plans and testing methodologies.
The provenance of the data is not specified beyond being generated by the device manufacturer, M.R.G. Industries Sdn. Bhd., located in Malaysia. It is implied to be prospective testing conducted by the manufacturer for regulatory submission.
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 is not applicable as the device is a medical glove, not a diagnostic or AI-driven decision support system requiring expert-established ground truth. The acceptance is based on physical and biological testing against established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable for the type of device and testing described. Adjudication methods are typically relevant for subjective assessments, particularly in clinical trials or AI performance evaluations, not for objective material property testing.
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 is a medical glove, not an AI or imaging device that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a medical glove, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on objective measurements against established performance standards and biocompatibility tests. For example:
- Physical properties (e.g., tensile strength, elongation, dimensions) are measured against criteria specified in ASTM D 3578-95.
- Freedom from holes is tested per ASTM D 3578-95.
- Biocompatibility (skin irritation and sensitization) is assessed through animal studies (rabbit and guinea pig).
- Water extractable protein is measured objectively.
8. The sample size for the training set
Not applicable. The device is a physical product (glove) and does not involve AI or machine learning algorithms that require 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.