(34 days)
Stronghold Group Nitrile Examination Gloves, Powder Free is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
The subject device in this 510(k) Notification is Stronghold Group Nitrile Examination Glove, Powder Free. The subject device is a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250. Class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
The Stronghold Group Nitrile Examination Gloves, Powder Free, device performance was evaluated through non-clinical testing to demonstrate substantial equivalence to a legally marketed predicate device (K203191).
1. Acceptance Criteria and Reported Device Performance
The device performance was evaluated against the standards outlined in ASTM D6319-19 and ISO 10993 for various physical properties and biocompatibility. The table below summarizes the acceptance criteria and the reported results:
| Test Method | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|
| ASMT D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Dimensions Test (Width) | Width: 91 mm (Mean) (for medium size) | Passed (The specific measured value is not provided, but it met the criteria to be termed "Passed") | Passed |
| ASMT D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Dimensions Test (Length) | Length: 241 mm (Mean) (for medium size) | Passed (The specific measured value is not provided, but it met the criteria to be termed "Passed") | Passed |
| ASMT D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Dimensions Test (Thickness: Finger) | Thickness: Finger – 0.13 mm (Mean) | Passed (The specific measured value is not provided, but it met the criteria to be termed "Passed") | Passed |
| ASMT D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Dimensions Test (Thickness: Palm) | Thickness: Palm – 0.09 mm (Mean) | Passed (The specific measured value is not provided, but it met the criteria to be termed "Passed") | Passed |
| ASMT D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Requirements Test (Tensile Strength Before Aging) | Before Acceleration Aging: Tensile Strength (MPa): 34 (Mean) | Passed (The specific measured value is not provided, but it met the criteria to be termed "Passed") | Passed |
| ASMT D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Requirements Test (Ultimate Elongation Before Aging) | Before Acceleration Aging: Ultimate Elongation (%): 601 (Mean) | Passed (The specific measured value is not provided, but it met the criteria to be termed "Passed") | Passed |
| ASMT D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Requirements Test (Tensile Strength After Aging) | After Acceleration Aging: Tensile Strength (MPa): 34 (Mean) | Passed (The specific measured value is not provided, but it met the criteria to be termed "Passed") | Passed |
| ASMT D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application - Physical Requirements Test (Ultimate Elongation After Aging) | After Acceleration Aging: Ultimate Elongation (%): 571 (Mean) | Passed (The specific measured value is not provided, but it met the criteria to be termed "Passed") | Passed |
| ASTM D6319-19 (ASTM D5151-11) Standard Test Method for Detection of Holes in Medical Gloves | AQL 2.5 | Passed | Passed |
| ASMT D6319-19 (ASTM D6124-11) Standard Test Method for Residual Powder on Medical Gloves | ≤ 2.0 mg/glove | 0.12 mg/glove | Passed |
| ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for skin irritation and skin sensitization (Irritation) | Under the condition of study not an irritant | Under the condition of study not an irritant | Passed |
| ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for skin irritation and skin sensitization (Sensitization) | Under the conditions of the study not a sensitizer. | Under the conditions of the study not a sensitizer. | Passed |
| ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Under the conditions of study non cytotoxic | Non-cytotoxic reactivity at 100%, 50%, 25%, 12.5% and 6.25% extract concentration. (This indicates it was non-cytotoxic across all tested concentrations, meeting or exceeding the "non-cytotoxic" acceptance criteria). | Passed |
| ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for acute systemic toxicity | Under the conditions of the study no systemic toxicity | Under the conditions of the study no systemic toxicity | Passed |
| ISO 10993-23:2021 Biological evaluation of medical devices Part 23: Tests for skin irritation | Under the conditions of the study, no skin irritation | Under the conditions of the study, no skin irritation | Passed |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each non-clinical test conducted for the Stronghold Group Nitrile Examination Gloves. However, tests were conducted according to established ASTM and ISO standards, which typically specify minimum sample sizes for valid results.
The data provenance is from non-clinical testing (laboratory-based testing) of the Stronghold Group Nitrile Examination Gloves. The country of origin for the data is not specified directly in the provided text, but the testing was for a device manufactured by Stronghold Group. The testing is prospective in the sense that it evaluates the performance of the manufactured device directly.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the evaluation involved non-clinical laboratory testing against established physical and chemical standards (ASTM, ISO), rather than a clinical study requiring expert interpretation of results or ground truth establishment by medical experts. The "ground truth" for these tests is defined by the objective measurement criteria of the standards themselves.
4. Adjudication Method for the Test Set
This information is not applicable as the evaluation involved non-clinical laboratory testing with objective pass/fail criteria from recognized standards, not a process that would require expert adjudication.
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
This information is not applicable. The device is a "Nitrile Examination Glove, Powder Free" and does not involve AI or human reader interpretation. The testing focuses on the physical and biocompatibility properties of the glove.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable, as the device is a physical medical glove and does not involve any algorithms or AI.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests is based on established standard specifications and methodologies from ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization). For example, for dimensions, the ground truth is the specified range in ASTM D6319-19; for cytotoxicity, it's the qualitative assessment of "non-cytotoxic" based on ISO 10993-5.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical medical glove, and its performance evaluation did not involve machine learning models that require a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as above (no training set for a physical 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.