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510(k) Data Aggregation
(339 days)
The Single-use medical poly (vinyl chloride) 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 proposed device is Powder Free Vinyl Patient Examination Gloves which is made of poly vinyl chloride. The proposed device is clear, non-colored. The design of proposed device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The proposed device is non-sterile.
This document is a 510(k) Pre-Market Notification for a medical device: "Single-use medical poly (vinyl chloride) examination glove." It's primarily a comparison to a predicate device to establish substantial equivalence, not a study proving device meeting acceptance criteria in the context of advanced AI/medical imaging devices. Therefore, many of the requested categories are not applicable.
Here's an analysis based on the provided text, focusing on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally based on meeting the specifications of various ASTM and ISO standards for medical examination gloves. The reported device performance indicates that the proposed device meets these criteria.
| Test Item | Acceptance Criteria (Pass Criteria) | Reported Device Performance (Verdict) |
|---|---|---|
| Dimension (mm) | ASTM D5250 | Pass |
| Overall Length | Min 230 | >230/ Pass |
| Width | XS: 76±6; S: 85±5; M: 95±5; L: 105±5; XL: 115±5 | XS: 79-81/ Pass; S: 85-87 /Pass; M: 95-97/ Pass; L: 105-107/ Pass; XL: 115-117/ Pass |
| Finger thickness | 0.05 | 0.09-0.12/ Pass |
| Palm thickness | 0.08 | 0.08-0.09/ Pass |
| Freedom from Holes | Meet the requirements of ASTM D5151 AQL 1.5 | 0/125, 1/ 125, 4/315, 5/500, 3/200 leaks / Pass (Implies AQL 1.5 met) |
| Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | 0.3 – 0.42/ Pass |
| Physical Properties | ASTM D412 | Pass |
| Tensile Strength (MPa) | Meet the requirements of ASTM D412 Min 11 | 14-19/ Pass |
| Ultimate Elongation (%) | Meet the requirements of ASTM D412 Min 300% | 390 – 430/ Pass |
| Biocompatibility | ||
| Irritation | Non-irritating (ISO 10993-10) | Under the conditions of the study, not an irritant/ Pass |
| Sensitization | Non-sensitizing (ISO 10993-10) | Under conditions of the study, not a sensitizer./ Pass |
| Cytotoxicity | Non-cytotoxic (ISO 10993-5) | Under conditions of the study, did not show potential toxicity to L-929 cells./ Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document provides sample sizes for the "Freedom from Holes" test (e.g., 0/125, 1/125, 4/315, 5/500, 3/200 leaks). These numbers likely refer to the number of failed units out of the total tested for specific batches or sample groups to demonstrate compliance with AQL (Acceptable Quality Level) 1.5. For other tests like Dimensions, Powder Content, Physical Properties, and Biocompatibility, specific sample numbers are not explicitly stated, but are implied to be sufficient for compliance with the stated ASTM and ISO standards.
- Data Provenance: The document does not specify the country of origin of the data. Given the applicant is Anhui Bytech Medical Supplies Co., Ltd. in China and the submission correspondent is Shanghai SUNGO Management Consulting Co., Ltd. also in China, it's highly probable the testing was conducted in China. The data is based on non-clinical performance testing, effectively a prospective quality control assessment of manufactured gloves against established standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- This section is not applicable to this type of device submission. The "ground truth" for these tests are objective measurements against established technical standards (ASTM, ISO), not expert consensus on medical interpretation.
4. Adjudication Method for the Test Set
- This section is not applicable. The tests performed are objective measurements against defined criteria in standards, not subjective assessments requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret results with and without AI assistance. This document describes a physical medical device (examination glove).
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI algorithm. The device is a physical glove. Performance is measured directly from the physical characteristics of the glove.
7. The Type of Ground Truth Used
- The "ground truth" for the non-clinical performance and biocompatibility tests are the specifications and acceptable limits defined within the referenced international standards (ASTM D5250, ASTM D5151, ASTM D6124, ASTM D412, ISO 10993-10, ISO 10993-5). This is an objective, standardized basis for evaluation.
8. The Sample Size for the Training Set
- This concept is not applicable here. There is no "training set" in the context of an AI/machine learning model. The device's manufacturing process is designed to produce gloves meeting specifications, not "trained" on data.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no training set for this device.
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