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510(k) Data Aggregation
(90 days)
The disposable nitrile medical 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 available in color blue and white, and it provides five specifications: XS,S, M, L, and XL. The subject device is non-sterile.
The provided text describes the acceptance criteria and the study results for a Disposable Nitrile Examination Glove.
Here's the information extracted and formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ISO 10993-23:2021 Tests For Irritation | To determine if device is a skin irritant | The device must be a non-irritant | Pass |
| ISO 10993-10:2021 Tests For Skin Sensitization | To determine if device is a skin sensitizer | The device must be a non-sensitizer | Pass |
| ISO 10993-5:2009 Tests For In Vitro Cytotoxicity | To determine if the device is potential toxicity to L-929 cells. | The device must be a non toxicity. | Cytotoxic (Note: The summary later states this is the same as the reference device and does not affect substantial equivalence due to acute systemic toxicity results.) |
| ISO 10993-11:2017 Tests for Acute systemic toxicity | To determine if the device will cause acute systemic toxicity in vivo | The device must be a Non-acute systemic toxicity | Pass |
| ASTM D6319 (Physical Dimensions) | Physical Dimensions Test | Length(mm): S:≥220; M/L/XL:≥230; Width(mm): XS: 70±10mm; S:80±10mm; M:95±10mm; L: 110±10mm; XL: 120±10mm; Thickness (mm): Finger: ≥0.05, Palm: ≥0.05 | Length: > 240/Pass (for all sizes) Width (Blue color): XS: 74-76 /Pass; S: 82-86 /Pass; M: 95-97/ Pass; L: 104-106/ Pass; XL:115-117/ Pass Width (White Color): XS: 73-76 /Pass; S: 80-87 /Pass; M: 100-103/ Pass; L: 104-106/ Pass; XL:114-117/ Pass Thickness (Blue color): XS: Finger:0.10-0.12/Pass, Palm: 0.06-0.10/Pass; S: Finger: 0.09-0.12/Pass, Palm:0.07-0.09/Pass; M: Finger: 0.08 -0.12/Pass, Palm: 0.07-0.09/Pass; L: Finger: 0.09-0.12/Pass, Palm: 0.06-0.09/Pass; XL: Finger: 0.11-0.12/Pass, Palm: 0.06-0.09/Pass Thickness (White Color): Details for XS are visible, other sizes indicated but not fully detailed, likely indicating pass. |
| ASTM D6319 (Physical Properties) | Tensile Strength | Before Aging: ≥14MPa, After Aging: ≥14MPa | Before Aging: Blue color: 20-30/Pass; White Color: 16-35/Pass After Aging: Blue color: 20-30/Pass; White Color: 16-35/Pass |
| ASTM D6319 (Physical Properties) | Ultimate Elongation | Before Aging: ≥500%, After Aging: ≥400% | Before Aging: Blue color: 511-565/Pass; White Color: 436-521/Pass After Aging: Blue color: 511-565/Pass; White Color: 436-521/Pass |
| ASTM D6319 / ASTM D5151-19 | Freedom from Holes | G-1, AQL 2.5 | Complies with ASTM D6319-19 and ASTM D5151-19, G-1, AQL 2.5 (Implies Pass) |
| ASTM D6319-19 | Powder Content | < 2 mg per glove | Complies with ASTM D6319-19 (Implies Pass) |
| ASTM D6124-06 (Reapproved 2017) | Residual Powder on Medical Gloves | (Not explicitly stated in table, but standard implies criteria) | (Implied to be compliant as "adequately demonstrate the effectiveness") |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test beyond the implication that sufficient samples were tested to meet the requirements of the listed ASTM and ISO standards. These standards typically define appropriate sampling plans.
- Data Provenance: The text does not specify the country of origin for the data (e.g., where the tests were conducted or the materials sourced from). The study is non-clinical performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable as the described tests are laboratory-based physical and biocompatibility evaluations, not assessments requiring expert interpretation of diagnostic images or clinical scenarios.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable as the described tests are laboratory-based physical and biocompatibility evaluations.
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. This submission is for a disposable nitrile examination glove, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable. This submission is for a disposable nitrile examination glove.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance tests relies on established scientific and engineering standards and methodologies defined by organizations such as ISO and ASTM. For example, for tensile strength, the ground truth is the specified MPa value; for freedom from holes, it's the AQL (Acceptable Quality Limit). For biocompatibility, it's the biological response observed according to the specific ISO test protocols.
8. The sample size for the training set:
- This information is not applicable. This submission is for a physical medical device (glove), not a machine learning or AI algorithm that requires a training set.
9. How the ground truth for the training set was established:
- This information is not applicable. No training set was used.
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