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510(k) Data Aggregation
(169 days)
The Disposable Nitrile Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The subject device is powder free nitrile examination gloves. The subject device is Black/Lavender/Navy Blue/Burgundy. It can be available in five specifications: XS,S,M,L and XL.
The subject device is non-sterile.
This document is a 510(k) Premarket Notification for a Disposable Nitrile Examination Glove. It details the device's characteristics and compares it to a predicate device (K171422) to establish substantial equivalence.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm): XS/S: $\ge$ 220; M/L/XL: $\ge$ 230; Width (mm): XS: 70±10; S: 80±10; M: 95±10; L: 110±10; XL: 120±10 | Length(mm): > 230/Pass; Width(mm): XS: 70-77 /Pass; S: 77-86 /Pass; M: 95-99/ Pass; L: 109-114/ Pass; XL:117-120/ Pass |
| N/A (Section 6) | Thickness (mm) | Finger: ≥0.05; Palm: ≥0.05 | Finger: 0.08-0.11/Pass; Palm: 0.08-0.11/Pass |
| ASTM D412 | Physical Properties (Before Aging) | Tensile Strength: ≥14MPa; Ultimate Elongation: ≥500% | Tensile Strength: 15.3-17.9MPa/Pass; Ultimate Elongation: 496-588%/Pass |
| ASTM D412 | Physical Properties (After Aging) | Tensile Strength: ≥14MPa; Ultimate Elongation: ≥400% | Tensile Strength: 20.0-44.5MPa/Pass; Ultimate Elongation: 450-5710%/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 out of 125 samples tested) |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | 0.03-0.07mg/Pass |
| ISO 10993-5 | Biocompatibility - Cytotoxicity | Under conditions of the study, device extract is not cytotoxic (implied expectation, as the reported result confirms this) | Under conditions of the study, device extract is cytotoxic (This seems to be a typo/inconsistency in the document. The acceptance criterion from the predicate comparison is "Under conditions of the study, device extract is cytotoxic", implying the absence of cytotoxicity is the goal. The reported performance for ISO 10993-5 is the phrase "Toxicity" with the acceptance criteria being "Under conditions of the study, device extract is cytotoxic". This is highly confusing. Based on standard biocompatibility testing, the desired outcome for cytotoxicity is non-cytotoxic. However, the "Table 2 - Summary of non-clinical performance testing" explicitly lists "Toxicity" as the purpose and "Under conditions of the study, device extract is cytotoxic" as both the acceptance criteria and implied result. This is a critical discrepancy in the provided text. For a medical device, a cytotoxic extract would typically not be acceptable. Assuming the intent was for it to be non-cytotoxic, and that the "Results" column would show "Pass" for non-cytotoxicity, there's a clear error in the document as presented.) |
| ISO 10993-11 | Biocompatibility - Systemic Toxicity | Under conditions of the study, did not show acute systemic toxicity in vivo | Non-acute systemic toxicity / Pass |
| ISO 10993-10 | Biocompatibility - Irritation | Under the conditions of the study, not an irritant | Non-irritating / Pass |
| ISO 10993-10 | Biocompatibility - Sensitization | Under conditions of the study, not a sensitizer | Non-sensitizing / Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Watertightness Test (ASTM D5151): The reported performance "0/125/Pass" indicates a sample size of 125 units were tested.
- Other tests: The sample sizes for the remaining tests (Physical Dimensions, Thickness, Physical Properties, Powder Content, Biocompatibility) are not explicitly stated in the provided document.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. The manufacturer is Jiangsu Cureguard Glove Co., Ltd. in China, so it's reasonable to infer the testing was conducted in China, but this is not explicitly confirmed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This device (Disposable Nitrile Examination Glove) is a Class I medical device, which typically relies on established engineering and materials standards (e.g., ASTM, ISO) rather than expert human interpretation of complex medical images or outcomes.
- Therefore, the concept of "experts" establishing a "ground truth" as it would apply to AI/imaging diagnostics does not apply to the performance testing described for this device. The ground truth is defined by the objective measurement specifications in the referenced standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Again, due to the nature of the device and testing (physical and chemical properties measured against objective standards), no adjudication method of expert opinions was used or necessary. The results are based on objective measurements.
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
- An MRMC study is not applicable to this type of device. This device is a disposable examination glove, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a physical product, not an algorithm or software. The "standalone" performance is simply the device's ability to meet the specified physical, chemical, and biological criteria.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth for this device's performance testing is defined by objective engineering and material standards (e.g., ASTM D6319 for dimensions, ASTM D412 for physical properties, ASTM D5151 for watertightness, ASTM D6124 for powder content, and ISO 10993 series for biocompatibility). These standards provide the measurable criteria that the device must meet.
8. The sample size for the training set
- This is not applicable as the device is a physical product, not an AI model requiring a training set.
9. How the ground truth for the training set was established
- This is not applicable as the device is a physical product, not an AI model.
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