Search Results
Found 1 results
510(k) Data Aggregation
(43 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 blue. It can be available in five specifications: XS, S, M, L and XL. The subject device is non-sterile.
The provided document is a 510(k) Premarket Notification for a Disposable Nitrile Examination Glove, not an AI/ML medical device. Therefore, the information requested regarding acceptance criteria and study designs that are specific to AI/ML device performance (e.g., sample size for test/training sets, expert ground truth establishment, MRMC studies, standalone performance, etc.) is not applicable.
The document focuses on demonstrating substantial equivalence of the new glove to a legally marketed predicate device based on material, performance, and biocompatibility standards.
Here's a breakdown of the relevant information from the document related to performance and acceptance criteria for this non-AI/ML device:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm): XS/S: ≥220; M/L/XL: ≥230; Width (mm): XS: 70±10; S: 80±10; M: 95±10; L: 110±10; XL: 120±10; Thickness (mm): Finger: ≥0.05; Palm: ≥0.05 | Length (mm): > 230 / Pass; Width (mm): XS: 74-77 / Pass; S: 85-86 / Pass; M: 94-97 / Pass; L: 103-108 / Pass; XL: 114-118 / Pass; Thickness (mm): Finger: 0.08-0.09 / Pass; Palm: 0.06-0.07 / Pass |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125 / Pass (This likely means 0 failures out of 125 samples, meeting AQL 2.5) |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | 0.29-0.33mg / Pass |
| ASTM D412 | Physical Properties (Before Aging) | Tensile Strength: ≥14MPa; Ultimate Elongation: ≥500% | Tensile Strength: 14-30 MPa / Pass; Ultimate Elongation: 509-586 % / Pass |
| ASTM D412 | Physical Properties (After Aging) | Tensile Strength: ≥14MPa; Ultimate Elongation: ≥400% | Tensile Strength: 14-25 MPa / Pass; Ultimate Elongation: 418-533 % / Pass |
| ISO 10993-5 | Cytotoxicity | Non-Toxicity | "Under conditions of the study, device extract is cytotoxic." (Note: This might suggest a failure, but often with gloves, extract cytotoxicity is expected and evaluated in context of direct skin contact, which is covered by irritation/sensitization tests. Given the "Pass" results for irritation/sensitization, this might be a nuanced finding that doesn't preclude clearance.) |
| ISO 10993-11 | Acute Systemic Toxicity | Non-acute systemic toxicity | "Under conditions of the study, did not show acute systemic toxicity in vivo. / Pass" |
| ISO 10993-23 | Irritation | Non-irritating | "Under the conditions of the study, not an irritant. / Pass" |
| ISO 10993-10 | Sensitization | Non-sensitizing | "Under conditions of the study, not a sensitizer. / Pass" |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for each specific test, other than for the Watertightness Test (125 samples). The tests are non-clinical (laboratory-based) and conducted to verify compliance with specified ASTM and ISO standards. The data provenance is implied to be from the manufacturer (Anhui Kindguard Medical Supplies Technology Co., Ltd) in China, as it's part of their 510(k) submission. These are experimental results from a lab, not patient data, so "retrospective or prospective" is not applicable in the typical AI/ML sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The device is a medical glove, and its performance is assessed against technical specifications and standardized laboratory tests (e.g., dimensions, tensile strength, hole detection, biocompatibility assays), not through expert interpretation of clinical data like medical images.
4. Adjudication Method for the Test Set
Not applicable. Performance is determined by objective measurements and standardized test procedures, not human 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
Not applicable. This is not an AI/ML device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is defined by the acceptance criteria specified in internationally recognized standards (ASTM D6319, ASTM D5151, ASTM D6124, ASTM D412, ISO 10993 series). These standards provide objective measurement methodologies and thresholds for physical properties and biocompatibility.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device subject to training data.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is not an AI/ML device subject to training data.
In summary, the provided document is for a conventional Class I medical device (disposable examination gloves) and illustrates the data and tests required for a 510(k) clearance based on substantial equivalence. The questions posed are highly specific to AI/ML medical devices, which are not relevant to this submission.
Ask a specific question about this device
Page 1 of 1