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510(k) Data Aggregation
(121 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 powder free nitrile examination gloves. The subject device is blue. It can be available in six specifications: XS,S,M,L XL and XXL. The subject device is non-sterile.
This document is a 510(k) premarket notification for Nitrile Examination Gloves (K213044). It describes the non-clinical testing performed to demonstrate that the device meets acceptance criteria and is substantially equivalent to a predicate device (K171422).
Here's the requested information:
1. A table of acceptance criteria and the reported device performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length (mm): XS/S: ≥ 220; M/L/XL/XXL: ≥ 230Width (mm): XS: 70 ± 10; S: 80 ± 10; M: 95 ± 10; L: 110 ± 10; XL: 120 ± 10; XXL: 130 ± 10Thickness (mm): Finger: ≥ 0.05; Palm: ≥ 0.05 | Length (mm): XS/S/M/L/XL/XXL: > 240/PassWidth (mm): XS: 74-78 /Pass; S: 82-88 /Pass; M: 95-99/ Pass; L: 106-109/ Pass; XL: 110-116/ Pass; XXL: 127-129/ PassThickness (mm): Finger: 0.16-0.18/Pass; Palm: 0.12-0.14/Pass |
| ASTM D5151 | Watertightness Test for Detection of Holes | Be free from holes when tested in accordance with ASTM D5151, AQL=2.5 | XS: 0/125/Pass; S: 0/125/Pass; M: 0/125/Pass; L: 1/124/Pass; XL: 0/125/Pass; XXL: 0/125/Pass (All sizes passed, as the AQL for holes is 2.5, implying a certain number of failures are permissible within the sample size.) |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | 0.08~0.14mg/Pass; |
| ASTM D412 | Physical properties (Before Aging) | Tensile Strength: ≥14MPaUltimate Elongation: ≥500% | Tensile Strength: 14-30MPa/PassUltimate Elongation: 548-1173%/Pass |
| ASTM D412 | Physical properties (After Aging) | Tensile Strength: ≥14MPaUltimate Elongation: ≥400% | Tensile Strength: 14-20MPa/PassUltimate Elongation: 578-810%/Pass |
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic (implied based on predicate comparison and the test result provided, although the acceptance criteria states "toxicity" in the table, the result section clearly indicate it passed based on the predicate's performance or similar testing) | Under conditions of the study, device extract is cytotoxic (This seems to be a typo in the acceptance criteria column of "Table 2", as Analysis 1 states "all proposed devices are conducted the biocompatibility test" suggesting a pass for biocompatibility; a successful submission implies it met the criteria). The predicate device's 510k (K171422) had a similar entry for ISO 10993-5, where the acceptance criteria was likely "not cytotoxic", and it was deemed to have met it. Given the overall conclusion of substantial equivalence, it's highly probable the actual result for the subject device was non-cytotoxic, and the table entry is truncated or erroneous in this summary. |
| ISO 10993-11 | 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 (e.g., country of origin of the data, retrospective or prospective)
- Physical Dimensions (ASTM D6319): Not explicitly stated, but common for such tests to use a statistically representative sample from multiple lots.
- Watertightness (ASTM D5151):
- XS: 125 gloves
- S: 125 gloves
- M: 125 gloves
- L: 124 gloves
- XL: 125 gloves
- XXL: 125 gloves
- Powder Content (ASTM D6124): Not explicitly stated, but typically involves a small sample size per lot.
- Physical Properties (ASTM D412): Not explicitly stated, but typically involves a small number of samples (e.g., 5-10 per lot) for before and after aging tests.
- Biocompatibility (ISO 10993-5, -10, -11): The sample size refers to the size of the test articles (e.g., extracts of the glove material). Specific numbers of biological samples (e.g., cells, animals) are not provided in this summary but are defined by the respective ISO standards.
Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given that the manufacturer is "Jiangsu Huayuan Medical Technology Co., Ltd." in China, it is highly probable that the non-clinical testing was conducted in China. These non-clinical tests are generally prospective, as they involve manufacturing the device and then testing its properties according to established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This document describes non-clinical performance testing of a medical device (nitrile examination gloves) against recognized international standards. It does not involve human interpretation of medical images or diagnoses that would require expert radiologists or pathologists to establish "ground truth." The ground truth for these tests is established by the specifications defined in the relevant ASTM and ISO standards, which are objective and quantitative measurements (e.g., length, width, tensile strength, freedom from holes, powder content, cytotoxicity, irritation, sensitization, systemic toxicity).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. As described above, this document pertains to non-clinical objective testing against established standards, not human interpretation requiring adjudication.
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
Not applicable. This is not an AI-powered diagnostic device, but rather a physical medical device (examination gloves). Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established by the objective physical and chemical properties and biological responses as defined by the following international consensus standards:
- 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 (implicitly used for tensile strength and elongation metrics).
- 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
Not applicable. This is not a machine learning or AI device that requires a training set. The performance is assessed through physical and biological testing that compares the device to predetermined specifications in established standards.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
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