(14 days)
Blue Colour Powder Free Nitrile Rubber Examination Gloves 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™ Blue Colour Powder Free Nitrile Rubber Examination Glove is substantially equivalent to the Class 1 patient examination glove bearing the product code 80LYY (21CFR 880.6250). It meets all the current specifications listed under the ASTM Specification D 6913-00a, Standard Specification for Nitrile Examination Gloves. They are made from nitrile rubber compound. They are blue in color and are powder free.
The provided document describes the acceptance criteria and the study conducted for the Medtexx™ Blue Colour Powder Free Nitrile Rubber Examination Gloves.
Here's the breakdown:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (ASTM D 6319-00a) | Reported Device Performance (Medtexx™ Gloves) |
|---|---|---|
| Physical Properties | Meets ASTM D 6319-00a specifications | Meets ASTM D 6319-00a specifications |
| Biocompatibility | No irritation or sensitization | Negative for primary skin irritation and delayed contact sensitization |
| Powder-Free (Starch Presence) | Negative for starch | Negative for the presence of starch (USP iodine test) |
Note: The document states that the device "meets all the current specifications listed under the ASTM Specification D 6319-00a, Standard Specification for Nitrile Examination Gloves" and "Non-clinical laboratory and animal based test data indicate that the powder-free product meets all performance and biocompatibility requirements." However, specific numerical values for physical properties (e.g., tensile strength, elongation, force at break, freedom from holes) are not provided in this summary.
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 Test Set: The document does not explicitly state the sample size used for each specific test within ASTM D 6319-00a. However, it indicates testing was performed per ASTM D 6319-00a. This standard specifies sampling plans for various tests (e.g., visual inspection for defects, physical dimensions, physical properties, leak test).
- Data Provenance:
- Country of Origin: The test origin is not explicitly stated, but the submitter (Latexx Manufacturing Sdn. Bhd.) is based in Malaysia.
- Retrospective or Prospective: The testing described for this 510(k) is prospective, as it was conducted to demonstrate substantial equivalence for the new device 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 to the evaluation of examination gloves. The "ground truth" for examination gloves is established through adherence to recognized international standards (ASTM D 6319-00a) for physical properties and validated laboratory test methods for biocompatibility and chemical composition. There are no human "experts" in the sense of medical diagnosticians establishing interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. The assessment involves physical, chemical, and biological testing against predefined scientific criteria, not subjective human interpretation requiring adjudication.
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. The device is a medical glove, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The phrase "standalone performance" typically refers to the performance of an AI algorithm. This device is a physical product (medical glove) and its performance is evaluated through laboratory and preclinical (animal) tests, not algorithmic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is established by:
- Accredited laboratory testing and adherence to published, universally accepted industry standards: Specifically, ASTM D 6319-00a for Nitrile Examination Gloves. This standard dictates test methods and acceptable limits for properties like dimensions, physical characteristics (tensile strength, elongation), and freedom from holes.
- Established biological testing protocols: For biocompatibility (primary skin irritation and delayed contact sensitization), validated animal models are used as the ground truth.
- Standardized chemical tests: For powder-free claims, a USP iodine test for starch is used.
8. The sample size for the training set
This is not applicable. The device is a manufactured product, not an AI model that requires a training set.
9. How the ground truth for the training set was established
This 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.