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510(k) Data Aggregation
(108 days)
LYDUS Nitrile Examination Gloves, Powder Free is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner.
The subject device in this 510(k) Notification is LYDUS Nitrile Examination Gloves, Powder Free. The subject device is a patient examination glove made from nitrile compound, blue color, powder free and non-sterile (Per 21 CFR 880.6250, Class I). The device meets the specifications in ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application.
This document is a 510(k) Premarket Notification for LYDUS Nitrile Examination Gloves, Powder Free. It aims to demonstrate that this device is substantially equivalent to a predicate device already legally marketed. As such, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance tests conducted to show the new device performs as safely and effectively as the predicate device, adhering to relevant standards.
Here's the information extracted from the provided text, formatted to address your questions. Please note that this document does not pertain to AI/ML medical devices, so many of your questions related to multi-reader multi-case studies, expert adjudication, or training/test sets for algorithms are not applicable and will be marked as such.
Device Performance Study Details
The study focuses on demonstrating the substantial equivalence of the LYDUS Nitrile Examination Gloves, Powder Free to a legally marketed predicate device (K192333, "Blue Nitrile Examination Gloves Powder Free"). This is achieved through non-clinical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
Device: LYDUS Nitrile Examination Gloves, Powder Free
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| Physical Dimensions (ASMT D6319-19) | To determine the width, length, and thickness of the gloves. | Width: 91 mm (Mean) (for medium size)Length: 241 mm (Mean) (for medium size)Thickness: Finger - 0.13 mm (Mean), Palm - 0.09 mm (Mean) | Passed (Specific measurements not detailed in "Result" column, but stated as "Passed") |
| Physical Requirements (ASMT D6319-19) | To determine the tensile strength and ultimate elongation before and after acceleration aging. | Before Acceleration Aging: Tensile Strength (MPa): 34 (Mean), Ultimate Elongation (%): 601 (Mean)After Acceleration Aging: Tensile Strength (MPa): 34 (Mean), Ultimate Elongation (%): 571 (Mean) | Passed (Specific measurements not detailed in "Result" column, but stated as "Passed") |
| Freedom from Holes (ASTM D6319-19 / ASTM D5151-11) | To determine the holes in the gloves (water tight - 1000 ml). | AQL 2.5 | Passed |
| Residual Powder (ASMT D6319-19 / ASTM D6124-11) | To determine the residual powder in the gloves. | < 2.0 mg/glove | 0.80 mg/glove (Meets criteria) |
| Skin Irritation (ISO 10993-10) | To determine the potential of the material to produce skin irritation in rabbits. | Under the condition of study not an irritant. | Under the condition of study not an irritant. |
| Skin Sensitization (ISO 10993-10) | To determine the skin sensitization potential of the material in guinea pigs. | Under the conditions of the study not a sensitizer. | Under the conditions of the study not a sensitizer. |
| In Vitro Cytotoxicity (ISO 10993-5) | To evaluate the in vitro cytotoxic potential of the test item (inner and outer surface) extracts in L-929 mouse fibroblasts cells using elution method. | Under the conditions of study non-cytotoxic. | Exhibit cytotoxic reactivity at 100% extract concentration (Grade 4 with neat extract). Non-cytotoxic reactivity at 50%, 25%, 12.5% and 6.25% extract concentration. (While 100% showed reactivity, lower concentrations were non-cytotoxic, which, according to the comparison table on page 6, is considered "Similar" to the predicate, implying acceptability). |
| Acute Systemic Toxicity (ISO 10993-11:2017) | The test item was evaluated for acute systemic toxicity in Swiss Albino Mice. | Under the conditions of the study no systemic toxicity. | Under the conditions of the study no systemic toxicity. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for each specific test (e.g., number of gloves tested for physical dimensions or holes). However, the tests are conducted according to the referenced ASTM and ISO standards, which would stipulate appropriate sample sizes for product quality control.
- Data Provenance: The manufacturer is Nathan Trading Co., Ltd. located in Thailand. The testing was non-clinical laboratory testing, performed to international standards. It is retrospective in the sense that it's a verification of product attributes, not a clinical trial.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not Applicable. This is a non-clinical performance test for a medical device (gloves), not an AI/ML diagnostic device requiring expert interpretation of medical images. The "ground truth" is defined by the established physical, chemical, and biological performance standards (ASTM and ISO).
4. Adjudication Method for the Test Set
- Not Applicable. As above, this is non-clinical product testing against defined standards, not a diagnostic task requiring human adjudication of ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No. This type of study is relevant for AI/ML diagnostic tools that impact human reader performance. It is not applicable to the performance testing of medical gloves.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Not Applicable. This document describes the performance of a physical medical device (gloves), not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is established by well-defined, internationally recognized consensus standards for medical gloves:
- ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
- ASTM D5151-11 Standard Test Method for Detection of Holes in Medical Gloves
- ASTM D6124-11 Standard Test Method for Residual Powder on Medical Gloves
- ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for skin irritation and skin sensitization
- ISO 10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for acute systemic toxicity
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/ML device; there is no "training set" in the context of machine learning. The manufacturing process of the gloves functions as the "training" (i.e., production under controlled conditions to meet specifications).
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no AI/ML training set, this question is not relevant. The "ground truth" for glove manufacturing is adherence to material specifications and manufacturing protocols designed to produce a product meeting the performance standards mentioned in point 7.
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