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510(k) Data Aggregation
(92 days)
The Vinyl 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 vinyl examination gloves. The subject device is clear. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
The provided document is a 510(k) Premarket Notification for Vinyl Examination Gloves, not an AI/ML medical device. Therefore, the information requested in the prompt regarding AI/ML device acceptance criteria and study details (such as sample sizes for test and training sets, expert ground truth, multi-reader multi-case studies, etc.) is not applicable and cannot be extracted from this document.
The document focuses on demonstrating substantial equivalence of the Vinyl Examination Gloves to a predicate device through non-clinical performance testing.
Here's a breakdown of the non-clinical acceptance criteria and reported performance, as directly extractable from the provided text, adapted to the table format requested:
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test (Length) | Length(mm): S/M/L/XL: ≥ 230 | Length(mm): > 230/Pass |
| ASTM D6319 | Physical Dimensions Test (Width) | Width(mm): S: 85±5; M: 95±5; L: 105±5; XL: 115±5 | Width(mm): S: 80-89 /Pass; M: 90-98/ Pass; L: 100-107/ Pass; XL:111-118/ Pass |
| ASTM D6319 | Physical Dimensions Test (Thickness) | Thickness (mm): Finger: ≥ 0.08; Palm: ≥ 0.08 | Thickness (mm): Finger: 0.08-0.17/Pass; Palm: 0.08/Pass |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125/Pass |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | 0.16-0.20mg/Pass |
| ASTM D412 | Physical properties (Tensile Strength - Before Aging) | ≥11MPa | 11-27MPa/Pass |
| ASTM D412 | Physical properties (Ultimate Elongation - Before Aging) | ≥300% | 304-607%/Pass |
| ASTM D412 | Physical properties (Tensile Strength - After Aging) | ≥11MPa | 11-24MPa/Pass |
| ASTM D412 | Physical properties (Ultimate Elongation - After Aging) | ≥300% | 300-499%/Pass |
| ISO 10993-5 | Cytotoxicity | In Vitro Cytotoxicity (Pass, implied by "Under conditions of the study, device extract is cytotoxic" for predicate but not for subject device - clarification needed for subject device's specific result from the provided table) | [Result not explicitly stated as "Pass" or "Fail" in the table for the main device, but a separate analysis states "Under conditions of the study, device extract is cytotoxic" which would imply fail for the subject device - this seems contradictory to implied substantial equivalence and needs careful interpretation of the table. Assuming a pass based on the conclusion.] |
| ISO 10993-11 | Acute Systemic Toxicity | Non-acute systemic toxicity | Under the condition of acute systemic toxicity test, the test article did not show acute systemic toxicity in vivo / Pass |
| ISO 10993-10 | Irritation | Non-irritating | [Result not explicitly stated as "Pass" or "Fail" in the table for the main device, but a separate analysis states "Under the conditions of the study, not an irritant or a sensitizer" for subject device which would imply pass.] |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer / Pass |
Regarding the other points, as this is a traditional medical device (gloves) and not an AI/ML algorithm, the following points are not applicable:
- Sample sized used for the test set and the data provenance: Not an AI/ML device. Test "set" refers to the specific gloves tested according to standards, not a dataset.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for gloves is defined by physical/chemical standards.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is for AI/ML devices assisting human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, this is for AI/ML algorithms.
- The type of ground truth used: Not applicable in the AI/ML sense. Ground truth is established by standardized physical and chemical testing methods (e.g., ASTM, ISO).
- The sample size for the training set: Not applicable; there is no training set for gloves.
- How the ground truth for the training set was established: Not applicable.
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