(35 days)
Powder Free Nitrile Rubber Examination Glove, Green Colour, is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.
Medtexx™ Powder Free Green Colour Nitrile Rubber Examination Glove meets all the current specifications listed under the ASTM Specification D 6319-00, Standard Specification for Nitrile Examination Gloves for Medical Application. They are made from nitrile rubber latex compound. They are natural white in color and are powder free.
The provided document is a 510(k) summary for "POWDER FREE GREEN COLOUR NITRILE RUBBER EXAMINATION GLOVES". It describes the device, its intended use, and the non-clinical tests performed to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (ASTM D 6319-00a for Nitrile Examination Gloves) | Reported Device Performance |
|---|---|
| Visual Inspection for flaws (e.g., holes, tears, embedded foreign objects, physical dimensions) | Not explicitly detailed, but implied to meet "all the current specifications" |
| Physical Properties (e.g., tensile strength, elongation at break, force at break) | Not explicitly detailed, but implied to meet "all the current specifications" |
| Freedom from holes (e.g., Water Leak Test) | Not explicitly detailed, but implied to meet "all the current specifications" |
| Protein Content (for latex gloves, not directly applicable to nitrile but a general consideration for glove safety) | Not applicable, as this is a nitrile glove. |
| Powder content (for powder-free gloves) | Final product is negative for the presence of starch using the USP iodine test. Implied to meet powder-free requirements. |
| Primary skin irritation | No irritation indicated by testing in rabbits. |
| Delayed contact sensitization | No sensitization indicated by testing in guinea pigs. |
| Biocompatibility requirements (general) | Met “all performance and biocompatibility requirements.” |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the document. The statement "Testing performed per ASTM D 6319 - 00a" implies that appropriate sample sizes as dictated by the standard were used, but the specific numbers are not mentioned.
- Data Provenance: The document states "Testing performed per ASTM D 6319 - 00a" and refers to "laboratory and animal based test data." This indicates the tests were conducted in a controlled environment (laboratory) and involved animal subjects (rabbits and guinea pigs), likely conducted by the manufacturer or a contracted lab. The country of origin of the data is not explicitly stated, but the manufacturer is based in Malaysia. These were non-clinical (pre-market) tests, which are typically prospective in nature for a new device submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to this type of device and study. The "ground truth" for examination gloves is established by objective engineering and biocompatibility standards (ASTM D 6319-00a and 21 CFR 800.20), not by expert consensus in interpreting images or clinical outcomes.
4. Adjudication method for the test set:
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies where human interpretation of medical data is being evaluated, typically for diagnostic devices. For examination gloves, performance is measured against objective 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. An MRMC study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) interpret cases with and without AI assistance. This device is an examination glove, which does not involve human interpretation or AI assistance in its function.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable. "Standalone" performance generally refers to the performance of an AI algorithm independent of human interaction. Since this device is an examination glove, it does not involve any algorithms.
7. The type of ground truth used:
- The ground truth used is based on established industry standards and regulatory requirements.
- ASTM Specification D 6319-00a: This standard defines the physical requirements (e.g., dimensions, tensile strength, elongation, freedom from holes) for nitrile examination gloves. The device's performance against these specifications serves as the factual "ground truth" for its physical properties.
- 21 CFR 800.20: This refers to the FDA's biocompatibility requirements for medical devices. The results from primary skin irritation and delayed contact sensitization tests against these requirements form the biocompatibility "ground truth."
- USP iodine test: Used to confirm the absence of starch, which is the "ground truth" for being "powder-free."
8. The sample size for the training set:
This information is not applicable. "Training set" refers to data used to train machine learning models. This device is a physical product (examination glove) and does not involve machine learning or AI.
9. How the ground truth for the training set was established:
This information is not applicable, as there is no training set for this 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.