(124 days)
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
Powder Free Nitrile Examination Gloves meets all the current specifications listed under the ASTM Specification D6319-00a, Standard Specification for Nitrile Examination Gloves for medical Application.
This document describes the acceptance criteria and performance data for non-sterile, powder-free nitrile examination gloves.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (ASTM D6319-00a & FDA) | Reported Device Performance (POWDER FREE NITRILE EXAMINATION GLOVES) |
|---|---|---|
| 1. Watertight (1000ml) | Multiple Normal GI, AQL = 2.5 | Pass GI, AQL = 2.5 |
| 2. Length (mm) | XS: Min 220, S: Min 220, M: Min 230, L: Min 230, XL: Min 230 | 240 mm minimum for all sizes |
| 3. Palm Width (mm) | XS: 70±10, S: 80±10, M: 95±10, L: 111±10, XL: 111±10 | 73-78 (XS), 83-88 (S), 93-98 (M), 103-107 (L), 103-107 (XL) |
| 4. Thickness (mm) (Single Layer) | ||
| Finger | Min 0.05 | Min 0.08 |
| Palm | Min 0.05 | Min 0.08 |
| 5. Physical Properties | ||
| Before Aging: Tensile Strength (Mpa) | Min 14 | 15 - 21 |
| Before Aging: Ultimate Elongation (%) | Min 500 | 550 - 630 |
| After Aging: Tensile Strength (Mpa) | Min 14 | 14 - 22 |
| After Aging: Ultimate Elongation (%) | Min 400 | 520 - 610 |
| 6. Powder Content | Max 2.0 mg/glove | Below 2 mg/glove |
| 7. Biocompatibility | Satisfactory Results (Implied by conclusion) | Primary Dermal Irritation Test, Guinea Pig Sensitization Test (passed) |
The performance data of the gloves shown above meet the ASTM D6319-00a Standard and FDA's requirements.
Study Information:
This document is a 510(k) summary for a medical device and provides performance data based on established standards rather than a typical clinical study with patient data. Therefore, some of the requested information (like sample size for test/training sets from patient data, ground truth establishment by experts for medical AI, MRMC studies) is not applicable in this context.
2. Sample Size Used for the Test Set and Data Provenance:
The document refers to performance data based on ASTM D6319-00a and FDA 1000ML watertight test.
- Sample Size: Not explicitly stated as a single "test set" in terms of patient cases. The ASTM standard specifies how many gloves from a lot must be sampled and tested for each criterion (e.g., AQL for watertightness). The number of individual gloves tested for each property (length, width, thickness, physical properties, powder content) would be determined by the specific sampling plans outlined in ASTM D6319-00a.
- Data Provenance: The manufacturing company is stated as ULTRAWIN SDN BHD in Malaysia. The testing was conducted to meet international standards (ASTM) and FDA requirements. Therefore, the data originates from testing conducted by or for the manufacturer, likely in Malaysia or accredited testing facilities. The data is retrospective in the sense that it's a report of tests already performed on manufactured products.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
Not applicable in the context of glove performance testing against technical standards. The "ground truth" for these tests is defined by the objective measurement methods and specifications within ASTM D6319-00a and FDA regulations. These are quantitative measurements that do not require expert consensus for interpretation in the way clinical diagnostic image interpretation would.
4. Adjudication Method for the Test Set:
Not applicable. The tests are based on objective measurements against specified ranges or thresholds (e.g., minimum length, maximum powder content, AQL for pinholes). There is no "adjudication" in the sense of resolving disagreements between human evaluators.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or screening devices involving human interpretation (e.g., radiologists reading images) and comparison of performance with and without AI assistance. This document pertains to the physical and barrier properties of examination gloves.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical product, not a software algorithm. The "performance" is the inherent property of the glove itself, measured directly.
7. The Type of Ground Truth Used:
The "ground truth" for the device's performance is based on objective measurement against established technical standards and regulatory requirements.
- ASTM D6319-00a Standard: This standard provides the specific test methods, acceptable ranges, and sampling plans for nitrile examination gloves.
- FDA Pinhole Requirements: Specifically, the 1000ml watertight test with an AQL of 2.5 is a regulatory requirement for barrier integrity.
- FDA Requirements for Powder Content: Stipulating a maximum of 2.0 mg/glove.
- Biocompatibility Tests: Primary Dermal Irritation Test and Guinea Pig Sensitization Test.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device that requires a training set of data.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this type of 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.