(92 days)
A powder-free 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 powder-free 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.
Here's a breakdown of the acceptance criteria and study information for the "Powderfree Latex Examination Gloves" described in the provided documents:
The documents provided are a 510(k) Summary and an FDA substantially equivalent letter for "Powderfree Latex Examination Gloves" manufactured by PT. Maja Agung Latexindo. This type of regulatory filing demonstrates substantial equivalence to a predicate device, rather than proving performance against novel acceptance criteria through a full-fledged clinical study.
Therefore, the study design and "acceptance criteria" here refer to meeting established industry standards for similar devices and demonstrating equivalence to a legally marketed predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance (from 510(k) Summary) |
|---|---|
| Dimensions (Length mm (min.)) | |
| Small: 240 | 240 |
| Medium: 240 | 240 |
| Large: 240 | 240 |
| X-Large: 240 | 240 |
| Margin of Error: ± 5 | - |
| Dimensions (Palm Width mm) | |
| Small: 80 | 80 |
| Medium: 95 | 95 |
| Large: 105 | 105 |
| X-Large: 110 | 110 |
| Margin of Error: ± 10 | - |
| Dimensions (Thickness mm (min.)) | |
| Cuff: 0.08 | 0.08 |
| Palm: 0.10 | 0.10 |
| Fingertip: 0.10 | 0.10 |
| Physical Properties (Before Ageing) | |
| Tensile Strength: 18 Mpa (min) | 18 Mpa (min) |
| Ultimate Elongation: 650 % (min.) | 650 % (min.) |
| Physical Properties (After Ageing at 70°C 168 hrs.) | |
| Tensile Strength: 14 Mpa (min) | 14 Mpa (min) |
| Ultimate Elongation: 500 % (min.) | 500 % (min.) |
| Pinhole Requirement | Meets FDA pinhole requirement |
| Compliance with Standard | Meets or exceeds ASTM D 3578-05ae2 Standard |
| Labeling Claim | Meets labeling claim |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in the provided documents. For physical property testing of gloves adhering to ASTM standards, specific sample sizes are typically defined within the ASTM standard (e.g., ASTM D3578-05ae2 for latex examination gloves specifies sampling plans for various tests like dimensions, physical properties, and watertightness).
- Data Provenance: The manufacturing location is "Jln. Utama No. 98 PUJI MULYO SUNGGAL - DELI SERDANG SUMATERA UTARA - INDONESIA". The testing data would originate from the manufacturer's quality control or third-party testing facilities related to their manufacturing process. The data is retrospective, as it refers to tests conducted on manufactured batches to ensure compliance with the standard.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- This question is not applicable in the context of this 510(k) submission. The "ground truth" for the performance specifications of these gloves is defined by the ASTM D 3578-05ae2 Standard and FDA's pinhole requirements. These are engineering and performance specifications, not subjective expert interpretations of medical images or outcomes. The "experts" involved would be the engineers and quality control personnel who conducted the tests and verified compliance with the standard.
4. Adjudication Method for the Test Set
- This is not applicable. Adjudication methods are typically for subjective assessments (e.g., medical image interpretation). The tests conducted for glove performance (tensile strength, elongation, dimensions, pinhole) are objective measurements against a defined standard.
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 is not a study involving human readers or AI assistance. It is a device 510(k) submission for examination gloves, which are physical medical devices, not diagnostic software.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is not an algorithm or software device.
7. The Type of Ground Truth Used
- The ground truth used is established industry standards and regulatory requirements, specifically:
- ASTM D 3578-05ae2 Standard for Powder-Free Latex Examination Gloves
- FDA pinhole requirement for examination gloves.
- The specifications defined in the 510(k) summary for dimensions and physical properties, which are derived from or meet these standards.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" in the context of this device manufacturing and regulatory submission. The gloves are manufactured and tested against predefined specifications.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set for this type of device. The specifications for performance (ground truth) were established over time through industry consensus and regulatory guidance, leading to standards like ASTM D 3578-05ae2.
§ 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.