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510(k) Data Aggregation
(144 days)
The Disposable Nitrile Medical Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The subject device is powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.
Acceptance Criteria and Device Performance for Disposable Nitrile Medical Examination Gloves (K210691)
The provided document describes the acceptance criteria and performance data for the Disposable Nitrile Medical Examination Glove (K210691) in comparison to the predicate device (K171422). The study primarily focuses on non-clinical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance (Results for 3 Lots) | Outcome |
|---|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test (Length) | XS/S: ≥220 mm; M/L/XL: ≥230 mm | Lot1, Lot2, Lot3: >230 mm | Pass |
| ASTM D6319 | Physical Dimensions Test (Width) | XS: 70±10 mm; S: 80±10 mm; M: 95±10 mm; L: 110±10 mm; XL: 120±10 mm | Lot1: XS: 78-80, S: 85-86, M: 95-96, L: 105-106, XL: 115-116Lot2: XS: 79-80, S: 85-86, M: 95-96, L: 105-106, XL: 115-116Lot3: XS: 78-80, S: 85-86, M: 95-96, L: 105-106, XL: 115-116 | Pass |
| ASTM D6319 | Physical Dimensions Test (Thickness) | Finger: ≥0.05 mm; Palm: ≥0.05 mm | Lot1: Finger: 0.11-0.13, Palm: 0.06-0.07Lot2: Finger: 0.11-0.13, Palm: 0.06-0.07Lot3: Finger: 0.11-0.13, Palm: 0.07 | Pass |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | Lot1: 0/125 leaksLot2: 0/125 leaksLot3: 0/125 leaks | Pass |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0 mg | Lot1: 0.09 mg/gloveLot2: 0.06 mg/gloveLot3: 0.08 mg/glove | Pass |
| ASTM D412 | Physical properties (Before Aging - Tensile Strength) | ≥14 MPa | Lot1: 28-36Lot2: 28-33Lot3: 23-33 | Pass |
| ASTM D412 | Physical properties (Before Aging - Ultimate Elongation) | ≥500% | Lot1: 510-570Lot2: 480-565Lot3: 515-566 | Pass |
| ASTM D412 | Physical properties (After Aging - Tensile Strength) | ≥14 MPa | Lot1: 27-33Lot2: 28-33Lot3: 28-32 | Pass |
| ASTM D412 | Physical properties (After Aging - Ultimate Elongation) | ≥500% | Lot1: 485-535Lot2: 480-530Lot3: 485-533 | 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 sample size for the test set is not explicitly stated as a single number but is indicated by the "3 Lots" tested for physical properties, watertightness, and powder content. For the watertightness test (ASTM D5151), a sample size of 125 gloves per lot was tested. The data provenance is China, as the manufacturer, Jiangsu Cureguard Glove Co., Ltd., is located in China. The testing appears to be prospective as it was conducted to demonstrate compliance with standards for a new device submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of device (medical examination glove) does not typically involve human expert interpretation or ground truth establishment in the same way an AI diagnostic tool would. The ground truth for this device is based on objective, quantitative measurements and standardized laboratory test procedures derived from established ASTM and ISO standards. Therefore, the concept of "experts" establishing ground truth for individual cases is not directly applicable here. The "experts" would be the scientists and technicians performing the standardized tests in a laboratory setting, adhering to the specified methodologies.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the testing conducted for this medical device involves objective measurements and standardized laboratory methods, not subjective interpretation requiring adjudication among human readers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data, and the AI's assistance is evaluated. For medical examination gloves, the performance evaluation is based on physicochemical and biological properties against established standards.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This question is not applicable to the device under review. The device is a physical medical glove, not an algorithm or software. The performance evaluation is inherently "standalone" in the sense that the glove's properties are measured directly, without human interpretation in a diagnostic loop.
7. The Type of Ground Truth Used
The ground truth used for this device's performance evaluation is objective laboratory measurements and compliance with established international standards (ASTM and ISO). This includes:
- Physical dimensions (length, width, thickness) measured against specified ranges.
- Mechanical properties (tensile strength, ultimate elongation) measured against minimum requirements.
- Barrier integrity (freedom from holes) measured against AQL (Acceptable Quality Level).
- Chemical properties (powder content) measured against a maximum limit.
- Biocompatibility (cytotoxicity, irritation, sensitization) evaluated through in vitro and in vivo (though described as "in vitro" for cytotoxicity, the irritation and sensitization tests typically involve animal or human models as per ISO 10993-10, even if the results are presented as "non-irritant" or "non-sensitizing" without detailing the specific model here) tests against pass/fail criteria.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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