(124 days)
The Nitrile Patient 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 powder free nitrile examination gloves. The subject device is blue. The subject device is non-sterile.
The provided document is a 510(k) Summary for a medical device called "Nitrile Patient Examination Glove." It outlines the device's characteristics, intended use, and comparison to a predicate device, along with non-clinical performance testing.
Here's the breakdown of the acceptance criteria and study information:
Acceptance Criteria and Reported Device Performance
| Item | Acceptance Criteria (Predicate Device K171422) | Reported Device Performance (Subject Device K210723) | Remark |
|---|---|---|---|
| Material | Nitrile | Nitrile | Same |
| Physical Properties | |||
| Before Aging | Tensile Strength: 14MPa, min | Tensile Strength: 14MPa, min | Same |
| Ultimate Elongation: 500% min | Ultimate Elongation: 500% min | Same | |
| After Aging | Tensile Strength: 14MPa, min | Tensile Strength: 14MPa, min | Same |
| Ultimate Elongation: 400% min | Ultimate Elongation: 400% min | Same | |
| Compliance | Comply with ASTM D6319 | Comply with ASTM D6319 | Same |
| Freedom from Holes | Be free from holes when tested in accordance with ASTMD5151 AQL=2.5 | Be free from holes when tested in accordance with ASTMD5151 AQL=2.5 | Same |
| Powder Content | Meet the requirements of ASTM D6124 | Meet the requirements of ASTM D6124 | Same |
| Biocompatibility | |||
| Irritation | Comply with ISO 10993-10:2010 | Under the conditions of the study, not an irritant | The subject device met the criteria for not being an irritant, which is considered compliant with ISO 10993-10. |
| Sensitization | Comply with ISO 10993-10:2010 | Under conditions of the study, not a sensitizer. | The subject device met the criteria for not being a sensitizer, which is considered compliant with ISO 10993-10. |
| Cytotoxicity | Comply with ISO 10993-5:2009 | Under conditions of the study, device extract is not cytotoxic | The subject device met the criteria for not being cytotoxic. While the predicate device column for cytotoxicity has a "/", the remark "Similar" implies an acceptable comparison or implied compliance for the predicate, and the subject device explicitly demonstrates compliance. |
| Device Dimensions | ASTM D6319-19 requirements (specific values present for predicate) | ASTM D6319-19 requirements (specific values present for subject) | The physical dimensions are little different but all meet the requirements of ASTM D6319-19, so the differences do not raise any new safety or performance questions. |
Study Information
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Sample sizes used for the test set and the data provenance:
The document does not specify exact sample sizes for each test. However, it indicates compliance with recognized standards such as ASTM D6319-19, ASTM D5151-19, ASTM D6124-06 (Reapproved 2017), ISO 10993-10:2010, and ISO 10993-5:2009. These standards inherently define appropriate sampling plans for testing.
The data provenance is from non-clinical tests conducted to verify design specifications. The company, Jiangxi Zhonghong Pulin Medical Products Co.,Ltd., is located in China. The nature of these tests (e.g., laboratory testing of material properties) implies prospective data collection as part of the device development and regulatory submission process. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the evaluation relies on established standardized test methods (e.g., ASTM, ISO standards) for material properties and biocompatibility, rather than expert interpretation of a diagnostic output. The "ground truth" is determined by the objective results of these standardized tests against their defined pass/fail criteria. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This is not applicable. The tests performed are objective, quantitative or qualitative measurements governed by international standards, not subjective interpretations requiring adjudication. -
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 is not applicable. The device is a patient examination glove, not an AI-powered diagnostic or assistive SaMD (Software as a Medical Device). Therefore, MRMC studies are not relevant. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is not applicable. The device is a physical medical glove, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device is based on objective, standardized test results against the specifications outlined in relevant ASTM and ISO standards for physical properties, barrier integrity, and biocompatibility. For example:- Physical properties (Tensile Strength, Elongation): Measured values compared against minimum requirements specified in ASTM D6319.
- Freedom from Holes: Determined by testing in accordance with ASTMD5151, with an Acceptance Quality Limit (AQL) of 2.5.
- Powder Content: Measured against requirements of ASTM D6124.
- Biocompatibility (Irritation, Sensitization, Cytotoxicity): Determined by laboratory assays compliant with ISO 10993-10 and ISO 10993-5, where the outcome is classified as "not an irritant," "not a sensitizer," or "not cytotoxic."
-
The sample size for the training set:
This is not applicable. The device is a physical product, not an AI/ML algorithm that requires a training set. -
How the ground truth for the training set was established:
This is not applicable for the same reason as above.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.