(313 days)
Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue is a disposable device intended for medical purposes that is worn on the examiner 's hand or finger to prevent contamination between the examiner and the patient.
The subject device of this submission is a Nitrile Examination Glove. The glove is non-sterile and meets the recommendations of ASTM 6319-10. The device is Blue in color.
This document is a 510(k) Premarket Notification for Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue. It demonstrates substantial equivalence to a predicate device (K112012). The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance specifications of the glove and the testing conducted to show compliance with those specifications and equivalence to the predicate device.
Here's an breakdown of the information requested, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents several characteristics and their corresponding standards/performance for the new device (K162510) and the predicate device (K112012). This can be structured as follows:
| Characteristic | Standard/Acceptance Criteria (for New Device) | Reported Device Performance (New Device K162510) | Reported Predicate Device Performance (K112012) |
|---|---|---|---|
| Dimensions | ASTM D 6319-10; Inspection Level-S-2 AQL 4.0 | Inspection Level-S-2 AQL 4.0 | Not explicitly stated as pass/fail; Implicitly meets the same general standard. |
| Physical Properties | ASTM D 6319-10; Inspection Level-S-2 AQL 4.0 | Inspection Level-S-2 AQL 4.0 | Not explicitly stated as pass/fail; Implicitly meets the same general standard. |
| Freedom from Pinholes – Water Tight Test (1000ML) | ASTM D 6319-10; ASTM D 5151-06; Inspection Level-G-1 AQL 1.5 | Inspection Level-G-1 AQL 1.5 | AQL 1.5 |
| Powder-Free Residue | ASTM D 6319-10; ASTM D 6124-06; Maximum 2mg/glove | Maximum 2mg/glove (Avg 1.0mg/glove) | Max 2.0mg/glove (Avg .22mg/glove) |
| Biocompatibility - Dermal Sensitization | Dermal Sensitization (as per ISO 10993-10); Not a contact skin sensitizer | Not a contact skin sensitizer | Non-sensitizer |
| Biocompatibility - Primary Skin Irritation | Primary Skin Irritation Test (as per 16 CFR Part 1500); Not a primary skin irritant | Not a primary skin irritant | Non-irritating |
| Tensile Strength (MPa) | ASTM D3578-05(2015); Before Aging: min 14.0; After Aging: min 14.0 | Before Aging: min 14.0; After Aging: min 14.0 | Before Aging: min 14.0; After Aging: min 14.0 |
| Elongation (%) | ASTM D3578-05(2015); Before Aging: min 500; After Aging: min 400 | Before Aging: min 500; After Aging: min 400 | Before Aging: min 500; After Aging: min 400 |
| Palm Width (Medium size) | 95mm +/-10 | 95mm +/-10 | 95mm +/- 10 |
| Length | 240mm min | 240mm min | 240mm min |
| Thickness (Palm and Finger) | Min .05mm Palm and finger | Min .05mm Palm and finger | Min .15mm Palm and Min .17mm finger |
| Sizes | XS - XL | XS - XL | XS - XL |
| Single Use | Yes | Yes | Yes |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document refers to "Inspection Level-S-2" and "Inspection Level-G-1" with associated AQLs (Acceptance Quality Limits) for various tests (e.g., Dimensions, Physical Properties, Freedom from Pinholes). These imply specific sampling plans outlined in the relevant ASTM standards (ASTM D 6319-10, ASTM D 5151-06, etc.). However, the exact number of units tested is not explicitly stated in this summary document.
- Data Provenance: Not explicitly stated in terms of country of origin of the data or whether it was retrospective/prospective. As this is a premarket submission for a physical device, the testing would have been conducted in a lab environment.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- This is not applicable in the context of this device. This document is about a physical medical device (gloves), not an AI/software device requiring expert interpretation of medical images or data. The "ground truth" for glove performance is established by adherence to specified physical and chemical characteristics and recognized ASTM and ISO standards, not by expert consensus on clinical interpretation.
4. Adjudication Method for the Test Set
- Not applicable. The "ground truth" is determined by objective physical and chemical testing methods (e.g., measuring dimensions, tensile strength, performing water leak tests, chemical residue analysis, biocompatibility assays), not through human adjudication of differing interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC study was not done. This type of study is relevant for AI/imaging devices where human reader performance is a key metric. For examination gloves, the focus is on physical and chemical properties and safety/performance equivalence.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is not an algorithm or AI device. The "performance" is the inherent physical and chemical properties of the glove.
7. The Type of Ground Truth Used
- The ground truth for this device is based on objective, standardized measurements and test methods defined by recognized national and international standards, primarily ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards. This includes:
- Physical Specifications: Dimensions (length, width, thickness), tensile strength, elongation.
- Functional Testing: Freedom from pinholes (water integrity).
- Chemical Analysis: Powder residue.
- Biocompatibility Testing: Dermal sensitization and primary skin irritation, conducted according to ISO 10993-10 and 16 CFR Part 1500.
8. The Sample Size for the Training Set
- Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, this is not a machine learning or AI 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.