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510(k) Data Aggregation
(109 days)
The Nitrile Patient Examination Gloves are non-sterile disposable devices intended for medical purposes that are worn on the examiner's hands or finger to prevent contamination between patient and examiner.
The subject device is powder free nitrile examination gloves. The subject device is cobalt blue. The subject device is non-sterile.
This document describes the acceptance criteria and the study that proves the device meets those criteria for Nitrile Patient Examination Gloves (K211012).
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm): ≥230 | Length: >230 mm (Pass) |
| Width (mm): XS: 80±10 S: 90±10 M: 100±10 L: 110±10 XL: 115±10 XXL: 125±10 | Width (mm): XS: 83-88 S: 90-94 M: 96-100 L: 109-114 XL: 117-121 XXL: 123-126 (Pass) | ||
| Thickness (mm): Finger: ≥0.05 Palm: ≥0.05 | Thickness (mm): XS: Finger: 0.08-0.10, Palm: 0.08-0.10 S: Finger: 0.07-0.11, Palm: 0.08-0.11 M: Finger: 0.08-0.12, Palm: 0.07-0.11 L: Finger: 0.08-0.13, Palm: 0.08-0.11 XL: Finger: 0.08-0.12, Palm: 0.08-0.13 XXL: Finger: 0.08-0.12, Palm: 0.08-0.13 (Pass) | ||
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | XS: 0/125 leaks S: 1/125 leaks M: 0/125 leaks L: 0/125 leaks XL: 0/125 leaks XXL: 1/125 leaks (Pass) |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | XS: 0.04 mg S: 0.06 mg M: 0.08 mg L: 0.07 mg XL: 0.10 mg XXL: 0.07 mg (Pass) |
| ASTM D412 | Physical Properties (Before Aging) | Tensile Strength: ≥14MPa Ultimate Elongation: ≥500% | Tensile Strength: XS: 15.4-16.6 S: 15.6-19.2 M: 15.9-17.3 L: 15.3-17.2 XL: 15.3-17.1 XXL: 15.6-17.2 (Pass) Ultimate Elongation: XS: 542-579 S: 536-571 M: 515-575 L: 521-562 XL: 523-568 XXL: 543-568 (Pass) |
| ASTM D412 | Physical Properties (After Aging) | Tensile Strength: ≥14MPa Ultimate Elongation: ≥400% | Tensile Strength: XS: 15.3-18.7 XXL: 15.8-17.2 (Pass - Note: Data for other sizes are not explicitly listed in the "Reported Device Performance" column for After Aging Tensile Strength, but "Pass" is indicated overall.) Ultimate Elongation: XS: 549-568 S: 538-570 M: 528-570 L: 523-564 XL: 529-570 XXL: 529-568 (Pass) |
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under conditions of the study, did not show potential toxicity to L-929 cells. (Pass) |
| ISO 10993-10 | Irritation | Non-irritating | Under the conditions of the study, not an irritant. (Pass) |
| ISO 10993-10 | Sensitization | Non-sensitizing | Under conditions of the study, not a sensitizer. (Pass) |
2. Sample Size Used for the Test Set and Data Provenance
The document provides specific sample sizes for some tests:
- Watertightness Test (ASTM D5151): 125 samples for each glove size (XS, S, M, L, XL, XXL).
- Data provenance is not explicitly stated (e.g., country of origin). The studies appear to be retrospective as they are testing completed devices against established standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the ground truth for glove testing is established through standardized laboratory procedures and measurements, not expert clinical consensus.
4. Adjudication Method for the Test Set
This information is not applicable as the testing involves objective measurements against predefined criteria, not subjective interpretations requiring adjudication.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices involving human interpretation, not for examination gloves.
6. Standalone Performance (Algorithm Only Without Human-in-the Loop Performance)
This information is not applicable. This device is a physical medical device (examination gloves), not an algorithm or AI system. Its performance is inherent to its physical properties, not a software component.
7. Type of Ground Truth Used
The ground truth used for these tests is based on established industry standards and regulatory requirements, specifically:
- ASTM D6319 (Standard Specification for Nitrile Examination Gloves for Medical Application)
- ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves)
- ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves)
- ASTM D412 (Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension) - Inferred from the physical properties testing.
- ISO 10993-5 (Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity)
- ISO 10993-10 (Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization)
8. Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of testing physical medical devices like examination gloves. The manufacturing process is controlled to ensure consistent product characteristics.
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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