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Found 6 results
510(k) Data Aggregation
(53 days)
NITRILE EXAMINATION GLOVES, PRE-POWDERED
THIS GLOVE IS DISPOSABLE AND INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
Nitrile Examination Gloves, Pre-Powdered, Blue Glove
This document is a letter from the FDA regarding a 510(k) premarket notification for "Nitrile Examination Gloves, Pre-Powdered, Blue Glove". It confirms that the device is substantially equivalent to legally marketed predicate devices.
The information requested in your prompt (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) is not present in this document. This letter is a regulatory approval document and does not contain details of the performance study itself. It only states that the device was found substantially equivalent for its intended use, which is "for medical purpose that is worn on the examiner's hand to prevent contamination between patient and examiner."
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(40 days)
NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR WHITE
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(25 days)
NITRILE EXAMINATION GLOVES, PRE-POWDERED, COLOR BLUE
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(31 days)
NITRILE EXAMINATION GLOVES- PRE-POWDERED, SMALL, MEDIUM, AND LARGE
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 examiners.
Private lebel-Nirile Examination Gloves Powder Free, Patient Examination Gloves, Nitrile 80 LZA. The document also provides detailed specifications for the gloves including sizes (XS, S, M, L, XL), length, width, and thickness at the cuff, palm, and finger tip. It also lists physical properties before and after aging, including Tensile Strength and Ultimate Elongation.
The provided document describes the acceptance criteria and performance of "Private label-Nitrile Examination Gloves Powder Free" (Nitrile Patient Examination Gloves Pre-powdered) manufactured by PT. Berlian Glovindo.
Here's an breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (Minimum/Range) | Reported Device Performance (Typical Values) |
|---|---|---|
| Dimensions (Length) | 240 mm (all sizes) | 240 mm |
| Dimensions (Width) | XS: 111 mm | > 111 mm |
| Thickness (Cuff) | 0.10 mm (min.) | 0.10 mm |
| Thickness (Palm) | 0.10 mm (min.) | 0.10 mm |
| Thickness (Finger Tip) | 0.10 mm (min.) | 0.10 mm |
| Tensile Strength (Before aging) | 14 Mpa (min.) | 14 Mpa (min.) |
| Ultimate Elongation (Before aging) | 700 % (min.) | 700 % (min.) |
| Tensile Strength (After aging) | 14 Mpa (min.) | 14 Mpa (min.) |
| Ultimate Elongation (After aging) | 500 % (min.) | 500 % (min.) |
| Pinhole Requirement | Meets FDA pinhole requirement | Meets FDA pinhole requirement |
| ASTM Standard | Meets ASTM D 3578-95 | Meets ASTM D 3578 Standard |
| Labeling Claim | Meets labeling claim | Meets labeling claim |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the sample size used for the performance testing.
- Data Provenance: The testing appears to have been conducted by the manufacturer, PT. Berlian Glovindo, based in Ceram, Indonesia, to certify the gloves meet specific standards. The data is retrospective in the context of the 510(k) submission, meaning the testing was performed prior to the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. For physical examination gloves, "ground truth" typically refers to objective measurements and adherence to established industry standards (like ASTM D 3578), rather than expert consensus on subjective interpretations.
4. Adjudication method for the test set:
- This information is not applicable/provided. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving subjective assessment by multiple human readers (e.g., medical image interpretation). For a device like examination gloves, performance is determined by objective measurements against established 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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices, not for physical medical devices like examination gloves. The document pertains to the performance of the gloves themselves, not the performance of human users with or without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical product (examination gloves), not an algorithm or AI system. Therefore, standalone algorithm performance is not a relevant concept here.
7. The type of ground truth used:
- The ground truth is based on objective measurements and adherence to established industry standards. Specifically, the document states:
- "We certify that these gloves meet ASTM D 3578 Standard."
- "Meets FDA pinhole requirement."
- "Meets labeling claim."
8. The sample size for the training set:
- Not applicable. This device is a physical product, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. As mentioned above, there is no training set for this type of device.
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(36 days)
NITRILE EXAMINATION GLOVES- PRE-POWDERED (SMALL, MEDIUM & LARGE)
A patient examination glove is a disposable device intended for medical purpose that is worn on examiner's hand or finger to prevent contamination between patient and examiners.
Private Label - Nitrile Examination Gloves Pre-Powdered, Blue and White Color
The provided document is a 510(k) submission for Nitrile Examination Gloves. It details the product, its intended use, and its technological characteristics and performance data compared to an equivalent device. However, it does not describe a study that uses AI or machine learning models or involves human readers and experts in the context of device performance evaluation.
Instead, the document focuses on the physical and performance attributes of the gloves, referencing ASTM standards and FDA requirements. Therefore, I cannot extract information related to AI performance, human reader studies, ground truth establishment, or sample sizes for AI training/testing from this document.
The acceptance criteria and reported device performance are related to the physical properties and dimensions of the Nitrile Examination Gloves as per ASTM D 3578-95 standards.
Here's the relevant information that can be extracted:
1. Table of Acceptance Criteria and the Reported Device Performance:
| Characteristic | Acceptance Criteria (ASTM D 3578-95) | Reported Device Performance (Nitrile Exam Gloves) |
|---|---|---|
| Dimensions | ||
| Length (min) mm | Not explicitly stated as "criteria", but 240 mm is consistently reported. | 240 mm |
| Palm width mm | Not explicitly stated as "criteria", but ranges are consistently reported. | Small: 85 ± 10 mm |
| Medium: 95 ± 10 mm | ||
| Large: 111 ± 10 mm | ||
| Thickness (min) | ||
| 1. Cuff (min) | Not explicitly stated as "criteria", but 0.1 mm is consistently reported. | 0.1 mm |
| 2. Palm (min) | Not explicitly stated as "criteria", but 0.1 mm is consistently reported. | 0.1 mm |
| 3. Fingertip (min) | Not explicitly stated as "criteria", but 0.1 mm is consistently reported. | 0.1 mm |
| Physical Properties (Before Aging) | Minimum values required by ASTM D 3578-95 | |
| Tensile Strength (min) | 14 Mpa | 14 Mpa |
| Ultimate Elongation (min) | 700 % (Small) | |
| 700 % (Medium) | ||
| 700 % (Large) | 700 % (Small) | |
| 700 % (Medium) | ||
| 500 % (Large) | ||
| Physical Properties (After Aging at 100° for 22 hrs) | Minimum values required by ASTM D 3578-95 | |
| Tensile Strength (min) | Not explicitly stated as "criteria", but 14 Mpa is consistently reported. | 14 Mpa |
| Ultimate Elongation (min) | Not explicitly stated as "criteria", but 500 % is reported for aged gloves. | 500 % |
| Inspection Related Defects | AQL (Acceptable Quality Level) | |
| Watertightness (Holes) | 2.5 (S-4) | Meets FDA pinholes requirement. |
| Dimension (Width, length, Thickness) | 4 (S-2) | Meets ASTM Standard. |
| Physical Properties (Before & After Aging) | 4 (S-2) | Meets ASTM Standard. |
| Weight of residual powder in medium size gloves: | 150 ± 50 mg | (Reported as a characteristic, no explicit criteria for passing) |
2. Sample size used for the test set and the data provenance:
- The document refers to "Inspection Related Defeats" with AQL (Acceptable Quality Level) values (e.g., S-4 for watertightness, S-2 for dimension and physical properties). These AQL values imply a sampling plan used for quality control, but the specific sample sizes for the test sets are not provided.
- The data provenance is for gloves manufactured by PT. EKA WIRA ASIA in Medan, Indonesia. The data is retrospective, as it describes the characteristics of the 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 as the document describes performance testing of physical products (gloves) against established ASTM standards, not evaluation by human experts using a ground truth.
4. Adjudication method for the test set:
- This information is not applicable for the same reason as point 3. Testing is against objective physical 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:
- This information is not applicable as the document is about the physical properties of examination gloves, not an AI-assisted diagnostic or interpretative device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This information is not applicable as the document is about the physical properties of examination gloves.
7. The type of ground truth used:
- The "ground truth" for the device's performance is established by ASTM D 3578-95 standards and FDA requirements (e.g., pinholes requirement). These are objective, pre-defined specifications rather than expert consensus, pathology, or outcomes data in a medical diagnostic context.
8. The sample size for the training set:
- This information is not applicable. There is no mention of a "training set" as the device is a physical product (gloves) and not an AI/ML model.
9. How the ground truth for the training set was established:
- This information is not applicable for the same reason as point 8.
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(253 days)
NITRILE EXAMINATION GLOVES-PRE POWDERED
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hand or finger to prevent contamination between patient and examiner.
NITRILE EXAMINATION GLOVES ( POWDERED
The provided text is related to a 510(k) clearance letter from the FDA for "Nitrile Powdered Examination Gloves." It does not contain any information about acceptance criteria, device performance studies, or AI/software analysis.
Therefore, I cannot fulfill your request for information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for the device, as none of this information is present in the provided document.
The document primarily focuses on the FDA's determination of substantial equivalence for the nitrile gloves to predicate devices and outlines regulatory responsibilities.
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