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510(k) Data Aggregation
(58 days)
The glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
Nitrile Examination Gloves, Dual Color Black-Blue are Class I Patient Examination Gloves. The glove is made dual color by double dipping. They are ambidextrous and come in different sizes - Extra Small, Small, Medium, Large, Extra Large and XXL. Gloves meet the specification of ASTM D6319-19. The gloves are single use, disposable, and provided non-sterile.
This document describes the non-clinical performance data for the "Nitrile Examination Gloves, Dual Color Black-Blue" (K232550) and compares it to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Methodology | Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319-19 | Physical Dimensions Length | Minimum 220mm for size XS-S; Minimum 230mm for size M-XXL | Pass |
| ASTM D6319-19 | Physical Dimensions Palm Width | XS: 70±10mm; S: 80±10mm; M: 95±10mm; L: 110±10mm; XL: 120±10mm; XXL: 130±10mm | Pass |
| ASTM D6319-19 | Physical Dimensions Thickness | Finger: 0.05mm (min); Palm: 0.05mm (min) | Pass |
| ASTM D6319-19 & ASTM D412-16(2021) | Physical Properties | Tensile Strength (Min 14 MPa) and Elongation (Before Aging 500% and after aging 400%) Min | Pass |
| ASTM D6319-19 & ASTM D5151-19 | Water leak test | G-I, AQL 2.5 (ISO 2859-1) | Pass |
| ASTM D6319-19 & ASTM D6124-06 (2017) | Powder Residue | Max 2mg/glove | Pass |
| ISO 10993-10 & 23:2021 | Irritation and Skin Sensitization | Skin sensitization and Skin irritation requirements (e.g., non-sensitizing, non-irritating) | Is non-sensitization and Non-irritation |
| ISO 10993-5:2009 | Cytotoxicity | Cytotoxicity reactivity (no adverse reaction) | showed potential toxicity to L929 cells. |
| ISO 10993-11:2017 | Acute systemic toxicity study | Subject showed no adverse biological reaction | no evidence of systemic toxicity. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test in the "Summary of Non-Clinical Performance Data" section. It refers to various ASTM and ISO standards, which typically specify sample sizes for their respective test methodologies. The data provenance is not specified, but it can be inferred that these are laboratory tests performed on samples of the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. These are laboratory-based performance tests for a medical device (examination gloves), not studies requiring expert interpretation of medical images or patient data. The "ground truth" is established by the standardized test methodologies themselves.
4. Adjudication Method for the Test Set
Not applicable. This is not a study requiring human adjudication. The results are based on objective measurements and observations according to standardized test protocols.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret medical cases. This document pertains to the performance of examination gloves.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This document is for a physical medical device (examination gloves), not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the performance criteria is established by the specifications defined within the referenced ASTM and ISO standards (e.g., minimum length, maximum powder residue, specified AQL for water leak test, biological response classifications).
8. The Sample Size for the Training Set
Not applicable. This document pertains to the performance of a physical medical device (examination gloves) through non-clinical testing, not a machine learning or AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable (as explained in point 8).
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