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510(k) Data Aggregation
(104 days)
Blue Nitrile Examination Gloves Powder Free is disposable devices intended for medical purpose that are worn on the examiner's hand to prevent contamination between patient and examiner.
Blue Nitrile Examination Gloves Powder Free are Class I patient examination gloves bearing the product code Nitrile - LZA (21CFR880.6250). The gloves are made from acrylonitrilebutadiene copolymer dispersion. These gloves are blue in color and are powder free.
The provided information is a 510(k) summary for "Blue Nitrile Examination Gloves Powder Free". This document describes the device and its equivalence to a predicate device, based on non-clinical performance testing. It does not describe a study involving an AI/Machine Learning driven medical device, human readers, or the establishment of ground truth by expert consensus for medical image interpretation or similar.
Therefore, most of the requested information regarding AI/ML device studies (e.g., number of experts, adjudication methods, MRMC studies, standalone algorithm performance, training set details) is not applicable to this document.
However, I can extract the acceptance criteria and reported device performance from the non-clinical testing summary as requested for a physical device:
Acceptance Criteria and Device Performance for Blue Nitrile Examination Gloves Powder Free
This document describes the non-clinical performance of the "Blue Nitrile Examination Gloves Powder Free" and its substantial equivalence to a predicate device (K192333). The study performed is a series of laboratory tests to ensure the physical and chemical properties of the gloves meet established standards.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-10 (Reapproved 2015) Standard Specification for Nitrile Examination Gloves for Medical Application | To determine the length of the gloves | Min 230 mm for all sizes | X-Small: 305 mmSmall: 305 mmMedium: 305mmLarge: 306mmX-Large: 306mm |
| ASTM D6319-10 (Reapproved 2015) Standard Specification for Nitrile Examination Gloves for Medical Application | To determine the width of the gloves | X-small: 70+/-10 mmSmall: 80+/-10 mmMedium: 95+/-10mmLarge: 110+/-10 mmX-Large: 120+/-10 mm | X-small: 74 mmSmall: 84 mmMedium: 94 mmLarge: 105 mmX-Large: 115 mm |
| ASTM D6319-10 (Reapproved 2015) Standard Specification for Nitrile Examination Gloves for Medical Application | To determine the thickness of the gloves | Palm 0.05 mm minFinger 0.05 mm min for all sizes | PalmX-Small: 0.10mmSmall: 0.10mmMedium: 0.10mmLarge: 0.10mmX-Large: 0.10mmFingerX-Small: 0.13mmSmall: 0.13mmMedium: 0.14mmLarge: 0.13mmX-Large: 0.14mm |
| ASTM D5151-06 (Reapproved 2015) Standard Test Method for Detection of Holes in Medical Gloves | To determine the holes in the gloves | AQL 1.5 | Passes AQL 1.5 |
| ASTM D6124-06 (Reapproved 2017) Standard Test Method for Residual Powder on Medical Gloves | To determine the residual powder in the gloves | 2 Mg/Glove Max | Residual Powder ContentX-Small: 0.21mg/gloveSmall: 0.21mg/gloveMedium: 0.22 mg/gloveLarge: 0.22 mg/gloveX-Large: 0.22 mg/glove |
| ASTM D6319-10 (Reapproved 2015) Standard Specification for Nitrile Examination Gloves for Medical Application | To Determine the physical properties - Tensile strength | Before Ageing: Tensile Strength 14Mpa Minimal for all sizesAfter Ageing: Tensile Strength 14Mpa Minimal for all sizes | Tensile Strength (Mpa)Before AgeingX-Small: 18.43Small: 18.49Medium: 18.54Large: 18.57X-Large: 18.64After AgeingX-Small: 17.49Small: 17.51Medium: 17.65Large: 17.67X-Large: 17.71 |
| ASTM D6319-10 (Reapproved 2015) Standard Specification for Nitrile Examination Gloves for Medical Application | To Determine the physical properties - Ultimate Elongation | Before Ageing: Ultimate Elongation 500% Min for all sizesAfter Ageing: Ultimate Elongation 400% Min for all sizes | Ultimate Elongation (%)Before AgeingX-Small: 685Small: 688Medium: 692Large: 695X-Large: 698After AgeingX-Small: 654Small: 658Medium: 661Large: 665X-Large: 669 |
| Biocompatibility (Primary Skin Irritation - ISO 10993-10:2010(E)) | Biocompatibility | Under the condition of study not an irritant | Under the condition of study not an irritant |
| Biocompatibility (Dermal Sensitization - ISO 10993-10:2010(E)) | Biocompatibility | Under the conditions of the study not a sensitizer | Under the conditions of the study not a sensitizer |
| Biocompatibility (In vitro cytotoxicity - ISO10993-5:2009(E)) | Biocompatibility | (Predicate: Under the conditions of the study, cytotoxic) (Subject: Under the conditions of the study, non-cytotoxic) | Under the conditions of the study, non-cytotoxic |
| Biocompatibility (Acute Systemic Toxicity Test ISO 10993-11:2017(E)) | Biocompatibility | Under the condition of study not systemic toxic | Under the conditions of study, the device extracts do not pose a systemic toxicity concern |
| Biocompatibility (Material Mediated Pyrogenicity ISO 10993-11:2017(E) / USP 41<151>) | Biocompatibility | Under the conditions of the study non pyrogenic | Under the conditions of the study non pyrogenic |
| Biocompatibility (Bacterial Endotoxin test USP 42<85>) | Biocompatibility | (Predicate: No data available) (Subject: <20EU/pair of gloves) | <20EU/pair of gloves |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the numerical sample sizes for each test. However, it indicates compliance with ASTM standards, which typically specify sampling plans. The data provenance is implied to be from the manufacturer's internal testing as part of the 510(k) submission process. The manufacturing location is Thailand ("Hi-Care Thai Gloves Co. Ltd. Thailand."). The specific tests are non-clinical, laboratory-based physical and chemical tests, not involving patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. This is for a physical device (examination gloves), not an AI/ML medical image analysis device requiring expert radiological review and ground truth establishment.
4. Adjudication Method for the Test Set:
Not applicable. This is for a physical device, not an AI/ML medical image analysis device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is for a physical device.
6. Standalone (Algorithm Only) Performance:
Not applicable. This is for a physical device.
7. Type of Ground Truth Used:
For this physical device, the "ground truth" is defined by the physical and chemical properties of the gloves as measured against established ASTM (American Society for Testing and Materials) and ISO (International Organization for Standardization) standards (e.g., ASTM D6319-10 for dimensions, physical properties, thickness; ASTM D5151-06 for water tightness/holes; ASTM D6124-06 for residual powder; ISO 10993 series for biocompatibility; USP for pyrogenicity and bacterial endotoxin).
8. Sample Size for the Training Set:
Not applicable. This is a manufactured physical good, not an AI/ML model.
9. How the Ground Truth for the Training Set was Established:
Not applicable.
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