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510(k) Data Aggregation
(283 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands of fingers to prevent contamination between patient and examiner.
Classified by FDA's General and Plastic Surgery Device panel as Class 1, 21 CFR 880.6250, Powder-Free Nitrile Patient Examination Glove. 80LZA, and meets all requirement of ASTM Standard D6319-10.
This document describes the premarket notification for the "Blue Nitrile Powder-Free Exam Glove" by Shandong Xinshi Medical Products Co., Ltd. The submission aims to demonstrate substantial equivalence to a predicate device.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Predicate Device Requirement | Device Performance (Blue Nitrile Powder-Free Exam Glove) |
|---|---|---|
| Mechanical Properties | ||
| Before Aging: Tensile Strength (Mpa) | Substantially equivalent | Average 28.77 Mpa |
| Before Aging: Ultimate Elongations (%) | Substantially equivalent | Average 759.23% |
| After Aging: Tensile Strength (Mpa) | Substantially equivalent | Average 24.00 Mpa |
| After Aging: Ultimate Elongations (%) | Substantially equivalent | Average 712.31% |
| Physical Dimensions | ||
| Overall Length on Medium Size | Substantially equivalent | Average 231 mm |
| Width of Palm on Medium Size | Substantially equivalent | Average 95.15 mm |
| Palm Thickness | Substantially equivalent | Average 0.08 mm |
| Finger Thickness | Substantially equivalent | Average 0.09 mm |
| Barrier Integrity | ||
| Free of Pinhole | Meets ASTM D5151-06 (AQL 2.5) | Testing result indicates pinhole were found less than two pieces gloves out of 125 pieces gloves. AQL 2.5 is met. |
| Material/Processing Residuals | ||
| Residue Powder | Meets ASTM D6124-06 (< 2 mg per glove) | Testing result indicates the weight of all types of residual or powder on finished powder-free gloves as < 2 mg per glove and there is no defect glove found according to ASTM D6124-06. |
| Biocompatibility | ||
| Primary Skin Irritation | Under the conditions of the study, not an irritant | Under the conditions of the study, not an irritant |
| Dermal Sensitization | Under conditions of the study, not a sensitizer | Under conditions of the study, not a sensitizer |
Study Details:
For medical gloves, the "study" typically refers to several non-clinical tests performed according to recognized standards to ensure the device performs as intended and is safe for use.
2. Sample Size Used for the Test Set and Data Provenance:
- Pinhole Test (ASTM D5151-06): The document states "less than two pieces gloves out of 125 pieces gloves." This indicates that a sample of 125 gloves was used for this particular test.
- Residue Powder Test (ASTM D6124-06): While a specific sample size isn't explicitly stated, the method implies testing on a sample of gloves to determine residual powder content.
- Physical and Dimensions Testing: "Inspection Level S-2. AQL 2.5" is mentioned, which refers to sampling plans defined in standards like ISO 2859-1. The exact sample size would depend on the lot size from which the samples were drawn.
- Data Provenance: The tests were conducted by Shandong Xinshi Medical Products Co., Ltd. in China, or laboratories commissioned by them. This is retrospective data from product testing for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable in this context. The "ground truth" for medical gloves is established by objective measurements against recognized performance standards (like ASTM standards) and validated test methods, not by expert consensus or interpretation of complex data like medical images. The test results themselves directly demonstrate compliance with the defined criteria.
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving human interpretation or subjective assessments. For objective performance testing of a physical medical device like a glove, the results of the specified test methods are directly compared to the acceptance criteria.
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 is not applicable. This question addresses AI/diagnostic imaging performance, which is entirely outside the scope of evaluating a medical glove.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. This question addresses AI algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance of the Blue Nitrile Powder-Free Exam Glove is based on objective measurements obtained through standardized laboratory test methods (e.g., tensile strength, elongation, pinhole detection, residual powder measurement, skin irritation tests) as defined by ASTM standards (specifically ASTM D6319-10, D5151-06, and D6124-06) and other relevant regulations (e.g., FDA 1000 ml. Water Fill Test).
8. The Sample Size for the Training Set:
This information is not applicable. The concept of a "training set" is relevant for machine learning algorithms. For a physical medical device, there is no "training set" in this sense. The manufacturing process is designed to consistently produce gloves meeting specifications, which is then validated through quality control and regulatory testing.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable for the reasons stated in point 8.
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