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510(k) Data Aggregation
(44 days)
SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, TESTED FOR CHEMOTHERAPY
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Patient Examination Glove, 80LZA, and meets all requirements of ASTM Standard D6319-00aE3.
The provided text is a 510(k) summary for a medical device: "Syntex Powder-Free Nitrile Examination Glove, Tested for Chemotherapy." Based on the provided document, the device is a Class I patient examination glove. The document describes non-clinical tests to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Standard | Reported Device Performance |
|---|---|
| Physical and Dimensions Testing: | |
| ASTM-D-6319-00aE3 (General Glove Standard) | "All testing meets requirements for Physical and Dimensions Testing conducted on gloves, Inspection Level S-2, AOL 4.0." And "Syntex Healthcare Products Co., Ltd. Syntex Powder-Free Nitrile Examination Glove, Tested for Chemotherapy conform fully to ASTM-D-6319-00a€3 standard..." |
| Pinhole / Water Leak Test: | |
| FDA 1000 ml. Water Fill Test (AQL 2.5, Inspection Level G-1) | "The FDA 1000 ml. Water Fill Test was also conducted with samplings of AQL 2.5, Inspection Level G-1, meeting these requirements." And "...meets pinhole FDA requirements." |
| Biocompatibility (Skin Irritation/Sensitization): | |
| Primary Skin Irritation and Skin Sensitization testing | "Primary Skin irritation and Skin Sensitization (allergic contact dermatitis) testing was conducted with results showing no primary skin irritant or sensitization reactions." And "...biocompatibility requirements..." |
| Powder Residue (for "powder-free" claim): | |
| ASTM D6124-01 for Starch (no more than 2 mg powder per glove) | "A Residual Powder Test that based on ASTM D6124-01 for Starch at finished inspection is conducted to insure that our gloves meet our "powder-free' claims (contain no more than 2 mg powder per glove)." |
| Chemotherapy Permeation (Implied based on device name, but not explicitly detailed in the summary) | The device is named "Tested for Chemotherapy," implying specific testing for this use. However, the 510(k) summary does not explicitly detail the acceptance criteria or results for chemotherapy permeation testing. It only states that the device "conform[s] fully to ASTM-D-6319-00a€3 standard as well as applicable 21 CFR references, and, meets pinhole FDA requirements. biocompatibility requirements and labeling claims as shown by data in Section 7." The lack of specific details for chemotherapy testing in Section 7 (Discussion of Non-Clinical tests) and Section 8 (Discussion of Clinical Tests) is a notable omission in this summary regarding the "Tested for Chemotherapy" aspect. |
2. Sample Size Used for the Test Set and the Data Provenance
- Physical and Dimensions Testing: Inspection Level S-2, AQL 4.0. (This refers to a sampling plan for quality control rather than a specific sample size for a "test set" in an AI/Software context).
- FDA 1000 ml. Water Fill Test: AQL 2.5, Inspection Level G-1. (Again, a sampling plan for quality control).
- Biocompatibility (Skin Irritation/Sensitization), Residual Powder Test: No specific sample sizes are mentioned for these tests, only that testing was "conducted."
- Data Provenance: Not applicable in the context of this device (a physical glove). The tests are performed on manufactured gloves.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable to this type of device (a physical examination glove). Ground truth in this context is established by physical measurements and laboratory analyses against defined standards, not by expert interpretation of data.
4. Adjudication Method for the Test Set
This information is not applicable to this type of device. Adjudication methods are typically used in studies involving human interpretation or subjective assessment.
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 information is not applicable to this type of device. An MRMC study is relevant for AI-powered diagnostic tools where human readers (e.g., radiologists) use the AI for assistance. This device is a physical glove.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable to this type of device. "Standalone performance" refers to the performance of an algorithm without human intervention, which is not relevant for a physical glove.
7. The Type of Ground Truth Used
The ground truth for this device's performance is based on defined physical and chemical standards as outlined in relevant ASTM standards and FDA requirements. This includes:
- Physical dimensions and tensile strength (ASTM-D-6319-00aE3)
- Barrier integrity (FDA 1000 ml. Water Fill Test for pinholes)
- Biocompatibility (Primary Skin irritation and Skin Sensitization testing via laboratory methods)
- Powder content (ASTM D6124-01)
- (Implied: Chemotherapy permeation data based on the device name, but methods/results are not detailed in this summary).
8. The Sample Size for the Training Set
This information is not applicable to this type of device. Training sets are relevant for machine learning algorithms, not for physical products like gloves.
9. How the Ground Truth for the Training Set was Established
This information is not applicable to this type of device, as it does not involve a training set for an algorithm.
Ask a specific question about this device
(83 days)
SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, PURPLE COLOR
A patient examination glove is a disposable device intended for medical purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
Powder-Free Nitrile Examination Glove -- Purple Color
The provided document is a 510(k) clearance letter from the FDA for a device called "Syntex Powder-Free Nitrile Examination Glove, Purple Color." This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any details related to AI or comparative effectiveness studies.
The letter explicitly states that the device is "substantially equivalent" to legally marketed predicate devices. This means that the FDA has determined the new device is as safe and effective as a device already on the market, based on its indications for use, technological characteristics, and performance data. However, the performance data itself, including specific acceptance criteria and study results, is typically found in the 510(k) submission summary, which is not part of this letter.
Therefore, I cannot provide the requested information from this document.
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(13 days)
SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE
A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.
Not Found
The provided text is a 510(k) clearance letter for the "Syntex Powder-Free Nitrile Examination Glove." This document focuses on the regulatory clearance for a medical glove, not on the performance of a diagnostic or AI-driven device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, expert qualifications, and comparative effectiveness studies is not present in the provided text.
The document states that the FDA has "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices." This means the device was cleared because it was found to be as safe and effective as an existing, legally marketed device, not through a study involving the kind of detailed performance metrics as would be required for an AI or diagnostic device.
The "Indications For Use" section on page 3 succinctly describes the intended purpose of the glove: "A glove is worn on the hand of healthcare worker and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment." This is a functional description, not a set of performance criteria with quantitative targets.
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