(134 days)
A powder-free 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. Gloves are available with finger textured surface in four sizes; Small, Medium, Large and X-large.
Midas TouchTM - Nitrile Examination Gloves - Powder free, Green
This is a 510(k) premarket notification for "Midas Touch 191 - Nitrile Examination Gloves - Powder Free. Green." This document does not describe a study that proves the device meets specific acceptance criteria in the manner that a medical imaging AI or diagnostic device would. Instead, it is an FDA clearance letter based on substantial equivalence to a predicate device.
Therefore, many of the requested items (sample sizes, expert qualifications, MRMC studies, standalone performance, training data, etc.) are not applicable to this type of regulatory submission.
However, I can extract the relevant information regarding the device and its indications for use.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
For examination gloves, the "acceptance criteria" are typically defined by recognized consensus standards, which include physical properties and barrier integrity. The FDA letter indicates that the device is "substantially equivalent" to legally marketed predicate devices, implying it meets the relevant performance standards for patient examination gloves. However, the specific performance data against these standards are not included in this clearance letter. This letter is the outcome of the review, not the detailed submission itself.
| Acceptance Criteria (General for Examination Gloves) | Reported Device Performance (Implied by Substantial Equivalence) |
|---|---|
| Barrier integrity (e.g., freedom from pinholes) | Meets relevant industry standards (e.g., ASTM D6319) |
| Physical properties (e.g., tensile strength, elongation) | Meets relevant industry standards (e.g., ASTM D6319) |
| Biocompatibility | Meets relevant industry standards |
| Powder-free status | Confirmed (device name specifies "Powder Free") |
| Sizing (Small, Medium, Large, X-large) | Available in these sizes |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This is not a study involving a test set of data in the context of an AI or diagnostic device. The clearance is based on demonstrating substantial equivalence to a predicate device, which typically involves testing the physical properties of the glove according to recognized standards. The sample sizes for these physical tests would be defined by the specific test methods (e.g., ASTM standards) but are not detailed in this clearance letter.
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. As above, there is no "ground truth" establishment in the context of image interpretation or diagnosis for this type of device. The quality and performance of the gloves are assessed through standardized physical and chemical tests, not expert consensus on medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable.
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. This device is an examination glove, not an AI or diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for examination gloves typically refers to the objective measurements of their physical and barrier properties against established, internationally recognized standards (e.g., ASTM D6319 for Nitrile Examination Gloves). These standards define acceptable performance ranges for attributes like tensile strength, elongation, and freedom from holes.
8. The sample size for the training set
- Not Applicable. This is not an AI or machine learning device; therefore, there is no training set.
9. How the ground truth for the training set was established
- Not Applicable.
Summary of Device and Indication for Use:
- Device Name: Midas Touch™ - Nitrile Examination Gloves - Powder free, Green
- Manufacturer: Industrial Clothings Ltd., Prime Polymers Division
- 510(k) Number: K130846
- Indications for Use: "A powder-free 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. Gloves are available with finger textured surface in four sizes; Small, Medium, Large and X-large."
- Regulatory Class: I
- Product Code: LZA (Patient Examination Glove)
This clearance indicates that the FDA has determined the device is "substantially equivalent" to currently marketed devices and can be legally marketed, based on fulfilling the general controls provisions of the Act and likely meeting relevant consensus standards. The detailed engineering and performance data are part of the original 510(k) submission, which is not fully included here.
§ 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.