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510(k) Data Aggregation
(107 days)
Vinyl Exam Gloves 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.
The proposed device is a powder free medical glove. The device is available in transparent. The device meets the requirements of ASTM D5250-19: Standard specification for Poly (vinyl chloride) Gloves for Medical Application. The proposed gloves are available in five sizes, which are XS, S, M, L, XL, it could be selected by the user depended on size of hand. The different between each size is just in the dimension. The proposed device is provided in non-sterile.
The provided document describes the acceptance criteria and a study proving the substantial equivalence of Vinyl Exam Gloves (K213019) to a predicate device. This is a 510(k) submission, focusing on non-clinical performance testing rather than clinical trials.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility - Skin Irritation (ISO 10993-10:2010) | Magnusson and Kligman grade shall be less than control group; No significant reaction than the control group | No skin irritation (Under the conditions of the study, not an Irritant) |
| Biocompatibility - Skin Sensitization (ISO 10993-10:2010) | (Implicitly same as irritation, often evaluated together - document states "Magnusson and Kligman grade shall be less than control group") | No skin sensitization (Under the conditions of the study, not a Sensitization) |
| Biocompatibility - Cytotoxicity (ISO 10993-5:2009) | The viability shall be not reduced to less than 70% | No cytotoxic (Under the conditions of the study, the device is non-cytotoxic) |
| Residual Powder (ASTM D6124-06 (Reapproved 2017)) | Less than 2.0mg per glove | Less than 2.0mg |
| Freedom from Holes (ASTM D5151-06 (Reapproved 2015)) | Do not show droplet, stream, or other type of water leakage | No leakage |
| Physical Dimensions - Length (ASTM D6319-10 (Reapproved 2015)) | > 230 mm | Larger than 230mm |
| Physical Dimensions - Width (ASTM D6319-10 (Reapproved 2015)) | XS = 75±5mm, S = 85±5mm, M = 95±5mm, L = 105±5mm, XL = 115±5mm | XS: within 75±5mm, S: within 85±5mm, M: within 95±5mm, L: within 105±5mm, XL: within 115±5mm (Note: Table 1 uses ASTM D5250-19 and lists width for XL as 105±5mm, but Table 2 uses D6319-10 and lists width for XL as 115±5mm. Assuming D6319-10 is the primary for this test type in T2 and the data aligns with it). |
| Physical Dimensions - Thickness (Finger & Palm) (ASTM D6319-10 (Reapproved 2015)) | All Sizes ≥ 0.08 mm | Larger than 0.08mm |
| Physical Properties - Tensile Strength (Before Aging) (ASTM 412-16) | 11MPa min | Larger than 11Mpa |
| Physical Properties - Ultimate Elongation (Before Aging) (ASTM 412-16) | 300% min | Larger than 300% |
| Physical Properties - Tensile Strength (After Aging) (ASTM 412-16) | 11MPa min | (Implied as "Same" in Table 1; Data not explicitly repeated in Table 2 for aged properties, but stated as meeting requirements for "Larger than 11Mpa and 300%") |
| Physical Properties - Ultimate Elongation (After Aging) (ASTM 412-16) | 300% min | (Implied as "Same" in Table 1; Data not explicitly repeated in Table 2 for aged properties, but stated as meeting requirements for "Larger than 11Mpa and 300%") |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes for each non-clinical test (e.g., how many gloves were tested for holes, dimensions, etc.). It generally states that "Non clinical tests were conducted to verify that the proposed device met all design specifications."
- Sample Size: Not explicitly stated for specific tests beyond what is implicit in the standard (e.g., ASTM standards typically define sample sizes).
- Data Provenance (Country of Origin): Not explicitly stated, though the manufacturer (Hebei Astro Medical Supply Co., Ltd) is based in China. The testing labs are not identified.
- Retrospective or Prospective: This distinction is not applicable to non-clinical bench testing. These are controlled performance tests conducted on representative samples of the manufactured device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to this type of submission. For medical gloves, "ground truth" is established by adherence to recognized international and national standards (e.g., ASTM, ISO) which define objective, measurable physical and biocompatibility properties. There are no human experts establishing a subjective "ground truth" for these tests in the same way, for instance, a radiologist would read an X-ray. The "experts" are the lab technicians and scientists performing the standardized tests according to defined protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or image interpretation studies where there is subjective assessment by multiple human readers. For standardized non-clinical performance and biocompatibility tests, the results are objectively measured against established 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
Not applicable. MRMC studies are specific to AI/CAD systems that assist human readers in interpreting medical images. This submission is for medical gloves, which do not involve human interpretation of images or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or AI system. It is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is defined by the acceptance criteria specified in recognized industry standards (ASTM D5250-19, ASTM D5151-19, ASTM D3767-03 (2020), ASTM D412-16, ASTM D6124-06 (Reapproved 2017), ISO 10993-10:2010, ISO 10993-5:2009, ASTM D6319-10). These standards provide objective, measurable parameters for physical properties (dimensions, tensile strength, elongation, freedom from holes, powder residue) and biological safety (irritation, sensitization, cytotoxicity).
8. The sample size for the training set
Not applicable. This device is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML device that requires a training set.
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(214 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or fingers to prevent contamination between patient and examiner.
Subject device: Vinyl Exam Gloves, Powder Free, Clear
Device Class: Class I
Regulation number: 21 CFR 880.6250
Product code: LYZ
Length: 230 mm min
Width: 94 mm min
Palm Thickness: 0.09 mm min
Fingertip Thickness: 0.085 mm min
Tensile Strength (Mpa) Before aging 16.96Mpa average After aging 14.92Mpa average
Ultimate Elongations Before aging 519% average After aging 480% average
Device functions: As a barrier, the subject device prevents contamination between patient and examiner
This document is a 510(k) Premarket Notification from the FDA regarding "Vinyl Exam Gloves, Powder Free, Clear". It's a regulatory submission for a medical device and does not describe an AI/ML powered device or a study related to AI/ML.
Therefore, I cannot provide the requested information about acceptance criteria and studies for an AI device. The document is about physical properties and biocompatibility of examination gloves, not an AI system.
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(39 days)
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.
VINYL EXAM GLOVES, POWDER-FREE, YELLOW
The provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria.
The document is a US FDA 510(k) clearance letter for "Vinyl Exam Gloves, Powder Free, Yellow." It states that the device is substantially equivalent to legally marketed predicate devices. This type of clearance relies on demonstrating substantial equivalence to pre-existing devices, rather than presenting new performance study data against specific acceptance criteria.
Therefore, I cannot provide the requested information based on the given text.
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(31 days)
This powder-free vinyl exam glove is intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
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.
The device is powder-free vinyl exam gloves. They are non-sterile, single use, disposable gloves.
Here's an analysis of the provided text regarding the acceptance criteria and study for the GLORMED INTERNATIONAL, INC. VINYL EXAMINATION GLOVE, POWDER-FREE:
It's important to note that this document is a 510(k) Summary for a medical glove, which is a relatively low-risk device. The regulatory requirements and the nature of the "study" for such devices are much simpler than for complex AI-powered diagnostic tools. Therefore, many of the requested categories (like MRMC studies, ground truth establishment for training data, number of experts for ground truth, etc.) are not applicable to this type of submission.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard/Test) | Device Performance |
|---|---|
| ASTM D5250 | Met and/or exceeded the requirements. (This standard specifies requirements for medical grade vinyl examination gloves.) |
| Primary Skin Irritation Study | Met and/or exceeded the requirements. (Implies no significant primary skin irritation was observed.) |
| Dermal Sensitization Study | Met and/or exceeded the requirements. (Implies no significant dermal sensitization was observed.) |
| FDA Water Leak, before & after aging | Met and/or exceeded the requirements. (This test assesses the integrity of the glove to prevent leakage, both initially and after simulated aging, which is critical for barrier protection. The specific threshold is not provided.) |
Study Details
Given the nature of the device (a vinyl examination glove), the "study" is a series of laboratory tests to demonstrate compliance with relevant standards and safety requirements.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test. For physical property tests like water leak, ASTM standards typically specify a sampling plan (e.g., AQL levels). For biocompatibility tests (skin irritation, sensitization), testing is typically done on a representative biological model or a small group of human volunteers.
- Data Provenance: Not specified, but the tests were performed "in a certified testing laboratory." The country of origin of the data is not mentioned, but it's presumed to be from a laboratory that can provide data acceptable to the FDA for a US market submission. The tests are prospective in the sense that they were conducted specifically for this device submission to demonstrate compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For physical and chemical tests of a medical glove, "ground truth" is established by the objective physical and chemical properties of the glove itself, as measured by standard laboratory procedures. Biocompatibility studies are typically evaluated by toxicologists or dermatologists, but the number of "experts" for ground truth adjudication in the AI sense is not relevant here.
4. Adjudication method for the test set:
- Not Applicable. As per point 3, adjudication in the context of expert consensus for AI is not relevant for these types of lab tests. The tests have pass/fail criteria based on standards.
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 device is a physical product (medical glove), 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 algorithm.
7. The type of ground truth used:
- Objective Test Results against Standards. The "ground truth" for the performance claims of the glove is the objective data obtained from the specified laboratory tests (e.g., water leak test, tensile strength implicit in ASTM D5250, results of irritation and sensitization studies) compared against the acceptance criteria defined by the relevant ASTM standards and FDA requirements.
8. The sample size for the training set:
- Not Applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable. As above, no training set for a physical device.
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