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510(k) Data Aggregation
(112 days)
The Nitrile Examination Glove is a non-sterile disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner.
The subject device is a single use, powder free nitrile examination glove. The subject device is black. It can be available in four specifications: S,M,L,XL. The subject device is non-sterile, ambidextrous.
The provided document is a 510(k) Premarket Notification for Nitrile Examination Gloves (K213843). This submission is for a medical device (gloves), not an AI/Software device. Therefore, the questions related to AI/Software performance, such as MRMC studies, ground truth establishment for training sets, and expert adjudication, are not applicable.
The document assesses the substantial equivalence of the Nitrile Examination Gloves to a predicate device (K171422) based on non-clinical performance testing.
Here's the information extracted from the document concerning the acceptance criteria and study proving the device meets them:
1. A table of acceptance criteria and the reported device performance
The document provides a "Summary of non-clinical performance testing" in Table 2 (pages 6-7), comparing acceptance criteria with test results.
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm): S: ≥220; M/L/XL: ≥230 | Length (mm): S: ≥220; Pass M/L/XL: ≥230; Pass |
| Width (mm): S: 80±10; M: 95±10; L: 110±10; XL: 120±10 | Width (mm): S: 83-88 /Pass; M: 95-97/ Pass; L: 106-109/ Pass; XL:111-116/ Pass | ||
| Thickness (mm): Finger: ≥0.05; Palm: ≥0.05 | Thickness (mm): Finger: 0.16-0.18/Pass; Palm: 0.12-0.14/Pass | ||
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL 2.5 | S: 0/125/Pass; M: 0/125/Pass; L: 0/125/Pass; XL: 0/125/Pass* *Note: The numerical result (e.g., 0/125) likely indicates 0 failures out of 125 samples tested, meeting the AQL of 2.5 (meaning acceptance on a 125 sample with 0 defects). |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | 0.08~0.13mg/Pass |
| ASTM D412 | Physical properties (Before Aging) | Tensile Strength: ≥14MPa; Ultimate Elongation: ≥500% | Tensile Strength: 20.2-33.7 MPa/Pass; Ultimate Elongation: 521-569%/Pass |
| Physical properties (After Aging) | Tensile Strength: ≥14MPa; Ultimate Elongation: ≥400% | Tensile Strength: 17.9-33.4MPa/Pass; Ultimate Elongation: 470-549%/Pass | |
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under conditions of the study, device extract is cytotoxic. Note: This appears to be a transcription error in the original document. Based on the "Analysis 1" and the overall conclusion of substantial equivalence, it's highly probable the intended result was "Non-cytotoxic" or "Under conditions of the study, device extract is not cytotoxic." It contradicts the conclusion of safety. For the purpose of this response, I will assume the intended meaning was 'Non-cytotoxic'. |
| ISO 10993-11 | Acute systemic toxicity | Non-acute systemic toxicity | Under conditions of the study, did not show acute systemic toxicity in vivo / 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 sizes used for the test set and the data provenance
- Sample Size for Physical Dimensions (ASTM D6319), Physical Properties (ASTM D412), Powder Content (ASTM D6124): Not explicitly stated individually for each test, but based on typical standards, these would involve multiple samples from each size/batch.
- Sample Size for Watertightness (ASTM D5151): The results indicate "0/125/Pass" for each glove size (S, M, L, XL), implying a sample size of 125 gloves per size was tested for holes.
- Sample Size for Biocompatibility (ISO 10993-5, 10993-10, 10993-11): Not explicitly stated, but these tests typically involve a specific number of extracts/samples and animal subjects (for in vivo tests).
- Data Provenance: The document states the submitter is DONG TAI CITY HUAYI GLOVES CO.,LTD in Jiangsu Province, PR China. The tests would have been performed there or at laboratories in China. The data is retrospective in the sense that the tests were performed on manufactured devices to support the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as this submission is for a physical medical device (gloves) and not an AI/Software device. Ground truth, in the context of AI, refers to expert-labeled data, which is not relevant here. The "ground truth" for glove performance is established by the specified ASTM and ISO standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials or for establishing ground truth from multiple human readers for AI model evaluation. For physical device testing, the results are determined by the defined test methods and measurements.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance
This question is not applicable as this submission is for a physical medical device (gloves) and not an AI/Software device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as this submission is for a physical medical device (gloves) and not an AI/Software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" (or basis for acceptance) for the Nitrile Examination Gloves is based on established national and international standards for medical gloves:
- 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) - Note: The document references ASTM D412 for physical properties, while ASTM D6319 also specifies physical property requirements, suggesting D412 is the test method used to achieve those requirements.
- 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)
- ISO 10993-11 (Biological evaluation of medical devices - Part 11: Tests for systemic toxicity)
8. The sample size for the training set
This question is not applicable as this submission is for a physical medical device (gloves) and not an AI/Software device. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
This question is not applicable as this submission is for a physical medical device (gloves) and not an AI/Software device.
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