(100 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination betweeen patient and examiner.
Non sterile, Powder free Nitrile Examination Glove, Blue with Polymer coating
This document describes the premarket notification (510(k)) for the "Non sterile, Powder free Nitrile Examination Glove, Blue with Polymer coating" by Siam Sempermed Corp., Ltd. The study aims to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| CHARACTERISTICS | STANDARDS | ACCEPTANCE CRITERIA (Implied by "Meets" or direct value) | DEVICE PERFORMANCE |
|---|---|---|---|
| Dimensions | ASTM D 6319-00-ae³ | Meets ASTM D 6319-00-ae³ requirements | Meets |
| Physical Properties | ASTM D 6319-00-ae³ | Meets ASTM D 6319-00-ae³ requirements | Meets |
| Freedom from pinholes | ASTM D 6319-00-ae³ | Meets ASTM D 6319-00-ae³ requirements | Meets |
| Powder Free Residue | ASTM D 6124-2006 | ≤ 2 mg/glove | ≤ 2 mg/glove |
| Biocompatibility (Primary Skin Irritation) | Primary Skin Irritation in Rabbits | Passed | Passed |
| Biocompatibility (Guinea Pig Sensitization) | Guinea Pig Sensitization | Passed | Passed |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the specific tests (Dimensions, Physical Properties, Freedom from pinholes, Powder Free Residue, Biocompatibility). The tests reference ASTM standards (ASTM D 6319-00-ae³ and ASTM D 6124-2006), which would specify sampling methods and sizes.
The data provenance is from non-clinical performance testing conducted by Siam Sempermed Corp., Ltd., in Thailand (based on the submitter's address). The data is prospective in the sense that it was generated for the purpose of this 510(k) submission to demonstrate the device's adherence to standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is a medical device performance study, not a study involving human expert interpretation of data like imaging. The "ground truth" for the device's performance is established by standardized testing methods and their inherent pass/fail criteria or quantitative limits, as defined by ASTM standards and biological testing protocols.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are typically used in studies where human readers interpret complex data and their interpretations need to be reconciled (e.g., in radiological studies). For material property testing and biocompatibility assessments, the results are derived directly from the test procedures, eliminating the need for adjudication of human interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, and the AI's impact on their performance is evaluated. This submission is for an examination glove, which does not involve human interpretation in the same way.
6. Standalone (Algorithm Only) Performance Study
No, a standalone (algorithm only) performance study was not done. This device is not an algorithm, but a physical product (a medical glove).
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- Adherence to recognized industry standards: ASTM D 6319-00-ae³ for dimensions, physical properties, and freedom from pinholes.
- Quantitative measurement against a specified limit: ASTM D 6124-2006 for powder-free residue (≤ 2 mg/glove).
- Biological testing outcomes: "Passed" for Primary Skin Irritation in Rabbits and Guinea Pig Sensitization, indicating non-toxicity/non-sensitization according to established biological evaluation protocols.
8. Sample Size for the Training Set
Not applicable. This device is a physical product, not an AI algorithm that requires a training set. The performance data is based on samples of the manufactured gloves being tested against established standards.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this 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.