(115 days)
Powdered Nitrile Examination Gloves, Non -Sterile is a disposable device and made of Synthetic Polymer that exhibits rubber like characteristics intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
The Powdered Nitrile Examination Gloves, Blue, Non Sterile meets all the requirements of ASTM standard D 6319-00a53 and FDA 1000 ml Water Leak Test.
Here's an analysis of the provided text regarding the acceptance criteria and study for the device:
Device: Powdered Nitrile Blue Examination Gloves, Blue, Non Sterile
1. Table of Acceptance Criteria and Reported Device Performance:
| CHARACTERISTICS | STANDARDS | DEVICE PERFORMANCE |
|---|---|---|
| Dimension | D 6319-00aE3 | Meets |
| Physical Properties | D 6319-00aE3 | Meets |
| Freedom from Pinholes | D 6319-00aE3 | Meets (implied by meeting FDA 1000 ml Water Leak Test and AQL requirements) |
| Freedom from Pinholes | FDA 21 CFR 800.20 | Meets (implied by meeting FDA 1000 ml Water Leak Test and AQL requirements) |
| Powder Residue | D 6319-00aE3 | 10 mg/dm² (specific numerical value provided) |
| Powder Residue | D6124 - 01 | 10 mg/dm² (specific numerical value provided) |
| Biocompatibility: Primary Skin Irritation | Primary Skin Irritation in Rabbits | Passes (No primary skin irritation) |
| Biocompatibility: Dermal Sensitization | Dermal Sensitization | Passes (No contact sensitizer) |
| Water Leak Test | FDA 1000 ml Water Leak Tes | Meets (specific mention in the conclusion for pinhole AQL) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document refers to "performance test data" but does not specify the number of gloves tested for each characteristic.
- Data Provenance: The document states the submitter is PT MAHAKARYA INTI BUANA, located in SUMUT - INDONESIA. The tests were likely conducted by or for this manufacturer, but the specific location of the testing facility is not provided. The study appears to be a prospective series of tests conducted to demonstrate compliance with established standards (ASTM and FDA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a Class I medical device (nitrile examination gloves) and the performance criteria are based on established engineering and safety standards (ASTM and FDA regulations), not on expert interpretations of complex data like medical images. The "ground truth" is defined by the objective pass/fail criteria of these standards.
4. Adjudication method for the test set:
- Not applicable. See point 3. The assessment involves physical and chemical tests against defined numerical or qualitative (e.g., "Passes") thresholds within established standards. There is no subjective interpretation requiring an adjudication process.
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:
- No. This is not a diagnostic imaging device or an AI-assisted device. Therefore, a MRMC study or AI assistance is not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical product (gloves), not an algorithm or software.
7. The type of ground truth used:
- The ground truth is based on established industry standards and regulatory requirements. Specifically:
- ASTM D 6319-00aE3: Standard Specification for Nitrile Examination Gloves for Medical Applications.
- FDA 21 CFR 800.20: Regulations for pinhole defects in medical gloves (referenced implicitly through the water leak test).
- ASTM D6124 - 01: Standard Test Method for Residual Powder on Medical Gloves.
- Biocompatibility Testing: Primary Skin Irritation in Rabbits and Dermal Sensitization tests (standard methods for assessing biological safety).
- FDA 1000 ml Water Leak Test: A specific test for glove integrity.
8. The sample size for the training set:
- Not applicable. This study does not involve machine learning or AI, and therefore, there is no "training set." The device itself is the product being tested.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
§ 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.