(235 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.
Not Found
This document describes the 510(k) premarket notification for "Midas Touch™ - Nitrile Examination Gloves - Powder Free, Grey." The FDA has determined the device is substantially equivalent to legally marketed predicate devices.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the format typically seen for complex medical devices with quantitative diagnostic or performance metrics (e.g., sensitivity, specificity, accuracy).
However, for patient examination gloves, the primary acceptance criteria revolve around meeting established ASTM standards for physical properties and barrier integrity. The "Premarket Notification (510k) Summary" (which is typically part of an FDA submission but not fully contained in the provided letter and Indications for Use) would detail these.
Based on the context of FDA substantial equivalence for examination gloves, the implied acceptance criteria are that the Midas Touch™ gloves meet the relevant ASTM standards. The "study that proves the device meets the acceptance criteria" would be the testing conducted by the manufacturer according to these standards.
Here's a hypothetical table based on typical glove testing for a 510(k) submission, as these are the "performance" aspects a glove device would need to demonstrate:
| Acceptance Criteria (Typically ASTM Standards) | Reported Device Performance (Implied) |
|---|---|
| Physical Properties | |
| Tensile Strength (before and after aging) | Met/Exceeded ASTM D412, D573 values |
| Elongation (before and after aging) | Met/Exceeded ASTM D412, D573 values |
| Barrier Integrity | |
| Freedom from Holes (AQL 2.5) | Met/Exceeded ASTM D5151 (e.g., AQL 1.5) |
| Biocompatibility | |
| Primary Skin Irritation | Passed ASTM F719, ISO 10993-10 |
| Dermal Sensitization | Passed ASTM F720, ISO 10993-10 |
| Powder Residue (for powder-free gloves) | Met/Exceeded ASTM D6124 |
| Labeling Requirements | |
| Indications for Use | As stated in the document |
| Material Statement | As stated in the document |
Note: The specific ASTM standards and target values would be detailed in the applicant's 510(k) submission. This table is illustrative of the types of criteria and performance typically required for examination gloves.
The "Study That Proves the Device Meets the Acceptance Criteria":
The "study" confirming the device meets the acceptance criteria would be a series of bench tests and laboratory assays conducted by the manufacturer, Industrial Clothings Limited, Prime Polymers Division. These tests would involve:
- Physical Property Testing: Measuring tensile strength and elongation using methods like ASTM D412 (Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension) and ASTM D573 (Standard Test Method for Rubber—Deterioration in an Air Oven). These tests would be performed on samples of the finished gloves, both before and after accelerated aging to simulate shelf life.
- Barrier Integrity Testing: Primarily through the water leak test according to ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves). This involves filling gloves with water and observing for leaks within a specified time, and reporting results based on Acceptable Quality Limits (AQL). An AQL of 2.5 is common for examination gloves, meaning a certain percentage of defects is acceptable. The applicant likely tested to an AQL of 1.5 as is commonly done.
- Biocompatibility Testing: Performing dermal irritation and sensitization tests on Guinea pigs (or other suitable models) according to standards like ASTM F719/F720 or ISO 10993-10 (Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization).
- Powder Residue Testing: For powder-free gloves, testing according to ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves) to ensure powder levels are below the specified maximum.
2. Sample Sizes Used for the Test Set and Data Provenance
- Test Set Sample Sizes: The document does not explicitly state the sample sizes used for each test. These details would be contained within the engineering and testing reports submitted as part of the 510(k). For glove testing:
- For physical properties, sample sizes are usually quite small (e.g., 5-10 gloves per batch per test condition).
- For the water leak test (AQL testing), sample sizes are determined by statistical sampling plans based on the batch size, as outlined in ASTM D5151 (e.g., ANSI/ASQ Z1.4). For a large batch, this could be hundreds of gloves.
- For biocompatibility, sample sizes are typically defined by regulatory toxicology guidelines (e.g., 3-5 animals per test group for irritation/sensitization).
- Data Provenance: The manufacturing entity is Industrial Clothings Limited, Prime Polymers Division, located in Sri Lanka. Therefore, the testing data would originate from their facilities or contracted testing laboratories, likely in Sri Lanka or elsewhere as required by testing standards. The data would be prospective as it's generated specifically for the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This question is not directly applicable in the context of examination gloves. "Ground truth" (in the sense of expert consensus on diagnostic findings) is relevant for diagnostic imaging or AI algorithms. For a physical device like a glove, the "ground truth" is established by adherence to universally accepted engineering and material science standards (e.g., tensile strength values in ASTM, AQL limits in D5151). The "experts" would be the testing technicians, quality engineers, and regulatory specialists who conduct and verify the adherence to these standards. Their qualifications would be expertise in materials testing, quality control, and relevant ASTM/ISO standards.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (2+1, 3+1) are used for resolving disagreements among multiple human readers on diagnostic tasks, typically in AI/imaging studies. For physical device performance, tests yield objective quantitative or pass/fail results, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. MRMC studies compare the performance of human readers (with or without AI assistance) on diagnostic cases. This device is a disposable medical glove, not a diagnostic AI system.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is a physical medical device (glove), not an algorithm or AI system.
7. Type of Ground Truth Used
As mentioned, "ground truth" for this device is based on established engineering and material science standards (e.g., ASTM standards) rather than pathology, outcomes data, or expert consensus on clinical findings. For example:
- The "ground truth" for tensile strength is the minimum value specified in the relevant ASTM standard.
- The "ground truth" for barrier integrity is the AQL level specified in ASTM D5151.
- The "ground truth" for biocompatibility is the absence of a significant irritative or sensitizing response according to recognized toxicology protocols.
8. Sample Size for the Training Set
Not applicable. This device does not use a "training set" in the context of machine learning or AI. The term "training set" refers to data used to train an algorithm. For a physical device, the equivalent concept might be the data from process validation runs or initial manufacturing batches used to optimize the production process, but this is distinct from an AI training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable for the same reasons as 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.