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510(k) Data Aggregation
(87 days)
The Disposable Nitrile Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
The subject device is powder free nitrile examination gloves. The subject device is blue. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
The provided document pertains to the 510(k) premarket notification for Nitrile Examination Gloves (K212922). This device is a Class I reserved medical device (non-powdered patient examination glove) and, as such, does not involve AI/ML technology or image analysis.
Therefore, the requested information regarding acceptance criteria, study details, human readers, ground truth establishment, etc., is not applicable to this type of medical device submission. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing of physical properties and biocompatibility.
Here's a breakdown of why each point of your request is not relevant in this context:
- Acceptance Criteria and Reported Device Performance: This device is a physical product (gloves), not an AI/ML system. The acceptance criteria relate to physical and chemical properties like dimensions, tensile strength, freedom from holes, powder content, and biocompatibility, not measures like accuracy, sensitivity, or specificity of an algorithm.
- Sample size for the test set and data provenance: No "test set" in the context of AI/ML models exists. The testing involves physical samples of gloves.
- Number of experts and qualifications for ground truth: No "ground truth" in the AI/ML sense is established. The "ground truth" for gloves is adherence to physical and biocompatibility standards.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is not an AI/ML diagnostic or assistive device for human readers.
- Standalone (algorithm-only) performance: Not applicable, as there is no algorithm.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" is established by adherence to recognized ASTM and ISO standards for glove manufacturing and safety (e.g., ASTM D6319, ASTM D5151, ISO 10993).
- Sample size for the training set: Not applicable, as there is no AI/ML model to train.
- How the ground truth for the training set was established: Not applicable.
Instead, the document details:
1. Acceptance Criteria and Reported Device Performance (Summary of Non-clinical Testing):
The acceptance criteria are derived from recognized standards like ASTM D6319 for physical dimensions, ASTM D5151 for watertightness, ASTM D6124 for powder content, and ASTM D412 for physical properties (tensile strength, ultimate elongation). Biocompatibility tests (ISO 10993-5, -10, -11) also have pass/fail criteria.
| Test Method | Purpose | Acceptance Criteria | Reported Performance / Results |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm): S: ≥220; M/L/XL: ≥230Width (mm): S: 80±10; M: 95±10; L: 110±10; XL: 120±10Thickness (mm): Finger: ≥0.05; Palm: ≥0.05 | Length (mm): S/M/L/XL: > 230/PassWidth (mm): S: 80-90 /Pass; M: 85-96/ Pass; L: 101-115/ Pass; XL:110-122/ PassThickness (mm):S: Finger: 0.08-0.15/Pass; Palm: 0.07-0.08/PassM: Finger: 0.10-0.18/Pass; Palm: 0.07-0.11/PassL: Finger: 0.11-0.18/Pass; Palm: 0.07-0.08/PassXL: Finger: 0.11-0.13/Pass; Palm: 0.07-0.08/Pass |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125/Pass (This implies 0 failures in a sample of 125, meeting the AQL of 2.5) |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | 0.12-0.15mg/Pass |
| ASTM D412 | Physical properties | Before Aging: Tensile Strength ≥14MPa; Ultimate Elongation ≥500%After Aging: Tensile Strength ≥14MPa; Ultimate Elongation ≥400% | Before Aging: Tensile Strength: 16-30MPa/Pass; Ultimate Elongation: 500-549%/PassAfter Aging: Tensile Strength: 14-26MPa/Pass; Ultimate Elongation: 435-525%/Pass |
| ISO 10993-5 | Cytotoxicity | In Vitro Cytotoxicity Test (Pass criteria not explicitly detailed but implied by "Pass" result) | Under conditions of the study, device extract is cytotoxic (This seems to be a typo/inconsistency in the original document, it states "is cytotoxic" but the result is "Pass" for the overall conclusion for the device. It likely meant "not cytotoxic" or a specific grade of cytotoxicity was deemed acceptable within the standard's criteria for a "Pass"). - Self-correction: The predicate device comparison table on page 5 shows "ISO 10993-5 Under conditions of the study, device extract is cytotoxic" for the predicate, and there is no specific result shown for the subject device in that table, only a "/" which typically means "not directly comparable" or "no specific difference noted for comparison". However, in Table 2 (Summary of Non-clinical Perf, page 6), it states "ISO 10993-5 Cytotoxicity - In Vitro Cytotoxicity Test - Pass". This implies the subject device did pass the cytotoxicity test, despite the conflicting statement in the comparison table. Given the final "Conclusion" states the device is as safe and effective, the "Pass" result is the definitive one for the subject device. |
| ISO 10993-11 | Acute Systemic Toxicity | Non-acute systemic toxicity (Pass criteria not explicitly detailed but implied by "Pass" result) | Under conditions of the study, did not show acute systemic toxicity in vivo / Pass |
| ISO 10993-10 | Irritation | Non-irritating (Pass criteria not explicitly detailed but implied by "Pass" result) | Under the conditions of the study, not an irritant/ Pass |
| ISO 10993-10 | Sensitization | Non-sensitizing (Pass criteria not explicitly detailed but implied by "Pass" result) | Under conditions of the study, not a sensitizer / Pass |
2. Sample Size and Data Provenance:
The document does not explicitly state the sample sizes for each physical test. However, for the ASTM D5151 Watertightness test, it shows "0/125/Pass," indicating a sample size of 125 gloves. The data provenance is presumed to be from the manufacturer (HSK Medical Apparatus Foshan China Co. LTD) based in China, generating the data for this 510(k) submission. These are non-clinical (laboratory) tests, not retrospective or prospective patient data.
3. Experts and Ground Truth Establishment:
Ground truth for physical/biocompatibility tests is established by the specifications defined in the referenced international (ISO) and national (ASTM) standards. These standards are developed by expert committees in their respective fields (e.g., materials science, biological evaluation). There aren't "experts" in the sense of clinical readers establishing ground truth for individual cases; rather, the "experts" are the standards themselves.
4. Adjudication Method:
Not applicable.
5. MRMC Comparative Effectiveness Study:
Not applicable.
6. Standalone Performance:
The performance demonstrated in Table 2 is the "standalone" performance of the physical glove product as measured against the established standards. There is no algorithm.
7. Type of Ground Truth Used:
The ground truth is based on accepted international and national consensus standards (ISO 10993, ASTM D6319, ASTM D5151, ASTM D6124, ASTM D412) for the manufacturing, physical properties, and biocompatibility of examination gloves.
8. Sample Size for Training Set:
Not applicable.
9. How Ground Truth for Training Set was Established:
Not applicable.
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