(68 days)
HEALTH + AID PREMIUM Powderfree Nitrike 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.
HEALTH + AID® PREMIUM Powder Free Nitrile Examination Gloves meet all the current specification listed under the ASTM Specification Examination Gloves, EXCEPT for ultimate elongation before ageing. They are blue or natural white in colour and are powder free.
Here's an analysis of the provided text regarding the acceptance criteria and study for the "HEALTH + AID® PREMIUM POWDER FREE NITRILE EXAMINATION GLOVES."
It's important to note that this document is a 510(k) summary for a medical glove, which is a relatively low-risk device. As such, the type of studies and acceptance criteria are vastly different from what would be expected for a complex AI/ML-driven diagnostic device. Many of the questions you asked are geared towards AI/ML devices and therefore will not be fully answerable from this submission.
Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Set by ASTM D 3578-95) | Reported Device Performance (HEALTH + AID® PREMIUM Powder Free Nitrile Examination Gloves) | Notes |
|---|---|---|
| Specific parameters of ASTM D 3578-95 | Meets all current specifications listed under ASTM D 3578-95, EXCEPT for ultimate elongation before ageing. | The specific values for each parameter from ASTM D 3578-95 are not provided in this summary, nor are the exact performance values of the device. However, a general statement of compliance (with one exception) is given. |
| Primary skin irritation (rabbit) | Indicates no irritation | Biocompatibility testing. |
| Delayed contact sensitization (guinea pig) | Indicates no sensitization | Biocompatibility testing. |
| Absence of starch | Negative for the presence of starch using the USP iodine test | Relevant for powder-free claims. |
Missing Information (Due to device type): For medical gloves, the primary "acceptance criteria" revolve around physical properties (e.g., tensile strength, elongation, barrier integrity) defined by consensus standards like ASTM D 3578-95, rather than diagnostic accuracy metrics (sensitivity, specificity, AUC) seen in AI/ML devices. The specific numerical targets for ASTM D 3578-95 and the device's actual performance values against those targets are not detailed in this summary.
Study Details (Applicable to this device type)
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Physical/Chemical Tests: The document states "Testing is performed as per ASTM D 3578-95 and 21 CFR 800.20." These standards specify sampling plans for testing. However, the specific number of gloves tested (sample size) for each physical property (e.g., tensile strength, elongation, freedom from holes) is not explicitly stated in this 510(k) summary.
- Data Provenance: Not explicitly stated, but typically these tests would be conducted by the manufacturer or a contracted lab. Given the submitter's address (Malaysia), it's highly probable the testing occurred there. These would be considered prospective tests performed on batches of the manufactured product.
- Sample Size for Biocompatibility Tests: For primary skin irritation and delayed contact sensitization tests:
- Primary skin irritation: Conducted in the rabbit. Typical sample sizes for such tests involve a small number of animals (e.g., 3-6 rabbits). The exact number is not specified.
- Delayed contact sensitization: Conducted in the guinea pig. Typical sample sizes for such tests involve a small number of animals (e.g., 10-20 guinea pigs for the test group, plus controls). The exact number is not specified.
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)
- Not applicable (N/A). For medical gloves, "ground truth" is established by adherence to physical, chemical, and biological performance standards (e.g., tensile strength values, absence of irritants). This is measured objectively by laboratory equipment and standard protocols, not by expert interpretation in the same way as an image-based diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable (N/A). Adjudication methods like 2+1 or 3+1 are used for human expert consensus in diagnostic studies (e.g., reviewing medical images). For medical gloves, performance is measured objectively against predefined specifications, not through expert consensus on qualitative observations.
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 (N/A). This device is a nitrile examination glove, not an AI/ML diagnostic system intended to assist human readers. Therefore, an MRMC study and effect size in the context of AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable (N/A). This device is a physical product (a glove), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for these gloves is defined by:
- Standard Specifications: Adherence to the physical performance requirements outlined in ASTM D 3578-95 (e.g., tensile strength, elongation, freedom from holes, dimensions). These are objective, measurable criteria.
- Biocompatibility Standards: Results from established animal models for irritation and sensitization.
- Chemical Tests: Specific tests like the USP iodine test for starch presence.
8. The sample size for the training set
- Not applicable (N/A). This device does not use machine learning, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable (N/A). This device does not use machine learning, so there is no "training set" and thus no ground truth to establish for it in this context.
§ 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.