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510(k) Data Aggregation
(24 days)
The powder-free 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.
Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange
The provided document is an FDA 510(k) clearance letter for Nitrile Powder Free Examination Gloves. This type of document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria for software or AI-powered medical devices.
The letter pertains to a Class I medical device (non-powdered patient examination glove), which is a physical product, not a software or AI-driven diagnostic or therapeutic tool. As such, the clearance process for such a device typically involves demonstrating substantial equivalence to a predicate device based on material properties, performance standards (e.g., tensile strength, barrier integrity), and biocompatibility, rather than algorithms, ground truth establishment, or human-in-the-loop studies.
Therefore, I cannot extract the requested information from the provided text because it describes the clearance of examination gloves, not an AI/software medical device.
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(47 days)
The powder-free 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.
AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile, (Blue, Black, Orange) are Class I patient examination gloves bearing the product code Nitrile - LZA (2 ICFR880.6250). AMADEX - Nitrile Powder Free Examnation Gloves Non-Sterile,(Blue, Black, Orange) meet all the requirements of ASTM standard D 6319-10 and FDA 21 CFR 880.6250. The AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile, (Blue, Black, Orange) is single-use device to prevent contamination between patient and examiner.
This document describes the acceptance criteria and study results for the AMADEX Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange) to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristics | Standard | Purpose | Acceptance Criteria | Reported Device Performance | Remarks |
|---|---|---|---|---|---|
| Dimensions | ASTM D 6319-10 | ||||
| Length | To determine the length of the gloves | Min 230 mm (All Sizes) | >230 mm (Passes) | Same | |
| Width (XS) | 70 ± 10 mm | 76 ± 3 mm | Same | ||
| Width (S) | 80 ± 10 mm | 84 ± 3 mm | Same | ||
| Width (M) | 95 ± 10 mm | 94 ± 3 mm (Also reported as 98 ± 2 mm, which passes 95 ± 10 mm) | Same | ||
| Width (L) | 110 ± 10 mm | 105 ± 3 mm | Same | ||
| Width (XL) | 120 ± 10 mm | 113 ± 3 mm | Same | ||
| Physical Properties | ASTM D 6319-10 | To determine the physical properties (Tensile strength and Elongation) | |||
| Tensile Strength (Before Aging) | 14 Mpa min | 24.5 Mpa (Passes) (Also reported as 14 Mpa in comparison table) | Same | ||
| Ultimate Elongation (Before Aging) | 500% min | 500% (Implied, as result is 14 Mpa and 500% in comparison table) | Same | ||
| Tensile Strength (After Aging) | 14 Mpa min | 14 Mpa (Implied) | Same | ||
| Ultimate Elongation (After Aging) | 400% min | 400% (Implied) | Same | ||
| Thickness | ASTM D 6319-10 | To determine the thickness of the gloves | Palm 0.05 mm min, Finger 0.05 mm min | Palm: 0.09 mm (Passes), Finger: 0.12 mm (Passes) | Same |
| Powder Free | ASTM D 6319-10, D 6124-06 | To determine the amount of residual powder and non-powder solids found on gloves | < 2 mg / glove | 0.60 mg / glove (Passes) | Same |
| Water Tightness | ASTM D 5151-06 | To determine the holes in the gloves | AQL 2.5 | AQL 2.5 (Passes) | Same |
| Biocompatibility | ISO 10993-10 | To determine the potential irritation of the effect likely to arise from a single exposure of test material on the intact skin of rabbits. | Under the condition of study not an irritant | Under the condition of study not an irritant | Same |
| ISO 10993-10 | To evaluate the potential of a test material to cause a delayed hypersensitivity reaction (Type IV) following exposure of the skin of guinea pigs. | Under the condition of study not an irritant | Under the condition of study not an irritant | Same | |
| Rubber Examination Gloves (General) | ASTM D 3578-05 | To determine the specifications for rubber examination gloves | Dimension, AQL: 4.0; Length: min 230 mm; Force at Break, AQL: 4.0, Tensile and Modulus | Meet the requirements of ASTM 3578 until 5 years (Passes) | - |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each individual test. However, it states that "All testing meets requirements for Physical and Dimensions testing conducted on gloves" based on the listed ASTM and ISO standards. These standards typically define the sampling plans and statistical methods for demonstrating compliance.
The data provenance is not explicitly stated in terms of country of origin but is from the manufacturer, Megine Industries Sdn Bhd, Malaysia, based on non-clinical testing performed to establish substantial equivalence for their device. The tests are described as non-clinical testing, implying the data is generated specifically for this submission. The nature of the tests (physical, chemical, and biocompatibility) suggests this is data collected under controlled laboratory conditions, likely prospective testing for this device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable. The product is an examination glove, and the "ground truth" is established through adherence to recognized international and national consensus standards (ASTM and ISO) for physical, chemical, and biocompatibility properties. These standards define objective performance criteria and test methods, rather than relying on expert clinical consensus or interpretation of complex medical data.
4. Adjudication method for the test set
This section is not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or image interpretation tasks where multiple human readers or experts evaluate data and consensus is needed. The testing for these gloves involves objective laboratory measurements against predefined acceptance criteria from 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
This section is not applicable. An MRMC study is relevant for AI-powered diagnostic devices or systems where human performance is being evaluated and compared with or without AI assistance. This device is a passive examination glove and does not involve AI or human interpretation in its function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. This device is a physical medical device (examination glove), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is based on objective measurements and predefined specifications within recognized international and national consensus standards. Specifically:
- ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
- ASTM D5151-19 Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D6124-06 Standard Test Method for Residual Powder on Medical Gloves
- ASTM D3578-05, 2015 Standard Specification for Rubber Examination Gloves
- ISO 10993-10: 2010, Biological evaluation of medical devices Part 10: Test for irritation and Skin Sensitization
These standards define the acceptable range for physical dimensions, mechanical properties, chemical residue, and biocompatibility, which serves as the definitive set of performance requirements.
8. The sample size for the training set
This section is not applicable. This device is not an AI/ML algorithm that requires a training set. The "training" for the manufacturing process involves adherence to Good Manufacturing Practices (GMP) and quality control systems in the production of the physical gloves.
9. How the ground truth for the training set was established
This section is not applicable for the same reason as point 8.
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