(70 days)
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Nitrile Examination Gloves, Powder Free Polymer Coated, Purple Color
The provided text contains information about the FDA's clearance of Nitrile Examination Gloves, Powder Free Polymer Coated, Purple Color. However, it does not contain the detailed acceptance criteria or the specifics of a study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter, which affirms substantial equivalence to a predicate device, but does not typically include the full technical study report.
Therefore, most of the requested information cannot be extracted from this document.
Here's what can be extracted, and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. This information is not present in the FDA clearance letter. Such details would typically be found in the manufacturer's submission or a detailed test report. The letter only states that the device is "substantially equivalent" to a legally marketed predicate device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. This information is not present.
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)
- Cannot be provided. This information is not present. The device is a glove, so "ground truth" and "experts" in the context of diagnostic performance are not applicable here. Performance criteria for gloves usually relate to physical properties like tensile strength, elongation, and barrier integrity (e.g., freedom from pinholes).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. This information is not relevant or present.
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
- Cannot be provided. This type of study (MRMC, AI assistance) is not applicable to an examination glove.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Cannot be provided. This is not applicable to a physical examination glove.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Ground truth for examination gloves typically involves objective physical and chemical testing against recognized standards (e.g., ASTM standards for medical gloves) for properties like dimensions, tensile strength, elongation, and barrier integrity (e.g., AQL for pinholes).
- Cannot be provided in detail from this document. The document does not specify the ground truth methods used in the testing for the glove, only that it met requirements for substantial equivalence.
8. The sample size for the training set
- Cannot be provided. Not applicable in the context of substantial equivalence for a physical device like a glove, which doesn't typically involve "training sets" in the AI/ML sense.
9. How the ground truth for the training set was established
- Cannot be provided. Not applicable.
Summary of available information from the document:
- Trade/Device Name: Nitrile Examination Gloves, Powder Free Polymer Coated, Purple Color
- Regulation Number: 880.6250
- Regulation Name: Patient Examination Gloves
- Regulatory Class: I (indicating lower risk and general controls apply)
- Product Code: LZA
- K Number: K030245
- Applicant: PT. ARISTA LATINO Industrial Limited, LTD.
- Indications For Use: "A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner."
- Basis for Clearance: Substantial Equivalence to legally marketed predicate devices.
To obtain the specific acceptance criteria and detailed study data (e.g., AQL levels for pinholes, tensile strength values, elongation at break), one would typically need to review the full 510(k) submission available through FDA's public access, or contact the manufacturer directly, as this information is not typically included in the clearance letter itself.
§ 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.