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510(k) Data Aggregation
(157 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner.
Powder Free Blue Nitrile Examination Glove meets all the current specifications listed under the ASTM Specification D6319-19, Standard Specification for Nitrile Examination Gloves for Medical Application. The principle operation and mechanism of this device is to prevent contamination between patient and examiner and this principle is achieved through testing of barrier, physical properties and other testing stated in the performance data. This device is for over-the counter single use.
The document provided describes the acceptance criteria and performance data for a Powder Free Nitrile Examination Glove (Blue), K220284, in comparison to a predicate device. This is a medical device submission, and the studies described are non-clinical performance data to demonstrate substantial equivalence, not studies related to AI or diagnostic algorithms. Therefore, many of the requested fields related to AI/algorithm performance (e.g., MRMC studies, standalone performance, training set details) are not applicable.
Here's the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|---|
| ASTM D6319-19: Dimensions | To measure the physical length and width of the gloves | Length: XS-Min 220mm, S-Min 220mm, M-Min 230mm, L-Min 230mm, XL-Min 230mm | Minimal Value for Length: XS: 240mm, S: 246mm, M: 240mm, L: 250mm, XL: 251mm | PASS |
| Width: XS-70 ± 10mm, S-80 ± 10mm, M-95 ± 10mm, L-110 ± 10mm, XL-120 ± 10mm | Minimal Value for Width: XS: 73mm, S: 84mm, M: 93mm, L: 104mm, XL: 111mm | PASS | ||
| ASTM D6319-19: Physical Properties | To measure the tensile strength and elongation before and after aging | Tensile Strength: Before Aging: 14.0 MPa, After Aging: 14.0 MPa | Tensile Strength: Before Aging: Minimal Value: 19.10 MPa, After Accelerated Aging: Minimal Value: 19.0 MPa | PASS |
| Ultimate Elongation: Before Aging: min. 500%, After Aging: min. 400% | Ultimate Elongation: Before Aging Minimal Value: 520%, After Aging Minimal Value: 480% | PASS | ||
| ASTM D6319-19: Thickness | To measure the physical palm and finger thickness of the gloves | Palm-Min. 0.05mm | Palm Minimal Value: XS: 0.07mm, S: 0.07mm, M: 0.07mm, L: 0.07mm, XL: 0.07mm | PASS |
| Finger-Min. 0.05mm | Finger Minimal Value: XS: 0.11mm, S: 0.11mm, M: 0.11mm, L: 0.11mm, XL: 0.12mm | PASS | ||
| ASTM D6319-19: Freedom from Holes Testing | To detect the presence of holes in glove | Meet AQL 2.5 at G1 | Meet AQL 2.5 at G1 | PASS |
| ISO 10993-10: Primary Skin Irritation | To determine the irritation potential of glove when exposed to skin surface | Not an irritant | Under the condition of study, not an irritant | PASS |
| ISO 10993-10: Dermal Sensitization | To determine the sensitization potential of glove when exposed to skin surface | Not a Sensitizer | Under the condition of study, not a sensitizer | PASS |
| ISO 10993-11: Acute Systemic Toxicity | To evaluate the adverse systemic reaction potential from glove | Not induce systemic toxicity | Did not induce systemic Toxicity | PASS |
| ASTM D6124-06: Residual Powder Analysis | To check the amount of powder residue from glove surface | Residual powder test (< 2 mg/glove) | Average 0.10mg/glove | PASS |
2. Sample size used for the test set and the data provenance
The document specifies "Minimal Value" and "Average" for various measurements, indicating that multiple samples were tested, but it does not provide the exact sample size for each test (e.g., number of gloves tested for dimensions, physical properties, etc.).
Data provenance: The testing was performed by KGM Gloves Sdn. Bhd. for their own device. The location of the manufacturer is Malaysia. The testing data is non-clinical performance data, likely gathered prospectively as part of product development and quality control.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" here refers to objective physical and chemical properties measured by standardized tests (e.g., ASTM and ISO standards) and laboratory procedures, not expert interpretation of medical images or other subjective assessments.
4. Adjudication method for the test set
Not applicable. The tests involve objective measurements and standardized protocols, 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 document is for a physical medical device (examination gloves), not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device.
7. The type of ground truth used
The ground truth used consists of objective measurements and laboratory test results against established international and national standards (ASTM D6319-19, ISO 10993-10, ISO 10993-11, ASTM D6124-06). For example, a glove's length is its measured length, and its tensile strength is the result obtained from the specified test method.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not a machine learning/AI device.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" as this is not a machine learning/AI device.
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