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510(k) Data Aggregation
(223 days)
The Nitrile 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.
Nitrile Examination Gloves are patient examination gloves made from nitrile compound, non-sterile (as per 21 CFR 880.6250, Class I). The principle operation of the medical device to provide single use barrier protection for the wearer and the device meets all the requirements specifications for barrier protection, tensile properties as defined in ASTM D6319-10, Standard specification for Nitrile Examination Gloves. The subject device is powder free nitrile examination gloves. The subject device is in blue color.
This document is a 510(k) Pre-Market Notification for Nitrile Examination Gloves (K210706). It reports on non-clinical testing to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions | Length (mm): ≥ 230; Width (mm): S: 80 ± 10; M: 95 ± 10; L: 110 ± 10; XL: 120 ± 10; Thickness (mm): Finger: ≥ 0.05; Palm: ≥ 0.05 | Length: ≥ 230; Width: S: 80-84, M: 95-99, L: 108-111, XL: 117-121; Thickness: Finger: 0.08-0.10, Palm: 0.06-0.08 (Pass) |
| ASTM D5151 | Watertightness | Meet the requirements of ASTM D5151 AQL 2.5 | 0/125 leaks (Pass) |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 < 2.0mg | 0.02 mg (Pass) |
| ASTM D6319 (ASTM D412) | Physical properties (Before Aging) | Tensile Strength: ≥ 14 MPa; Ultimate Elongation: ≥ 500 % | Tensile Strength: 26-35; Ultimate Elongation: 509-545 (Pass) |
| ASTM D6319 (ASTM D412) | Physical properties (After Aging) | Tensile Strength: ≥ 14 MPa; Ultimate Elongation: ≥ 400 % | Tensile Strength: 19-36; Ultimate Elongation: 447-510 (Pass) |
| ISO 10993-5 | Cytotoxicity | Cytotoxic (Note: The acceptance criteria here is for the study to detect cytotoxicity, not to "pass" by being non-cytotoxic. The reported result then indicates observation of slight toxicity.) | Under conditions of the study, show slight potential toxicity to L-929 cells (This is the reported result, not necessarily a "pass" in the typical sense, but an observation as per the test.) |
| ISO 10993-11 | Acute systemic toxicity | Non-toxicity | Under the condition of acute systemic toxicity test, the test article 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 Size Used for the Test Set and Data Provenance
The document does not explicitly state a separate "test set" in the context of an algorithm or AI model. Instead, it refers to samples tested for physical and biological properties of the nitrile gloves.
- Sample Size for Physical and Chemical Tests:
- Watertightness Test (ASTM D5151): 125 leaks (implied sample size tested to achieve 0/125 leaks).
- Other tests like physical dimensions, powder content, and physical properties (tensile strength, elongation) would have required a specific number of glove samples, but these exact numbers are not detailed in this summary. ASTM standards typically specify sample sizes for these tests.
- Data Provenance: The document does not specify the country of origin for the samples used in these non-clinical tests. The tests are for the Nitrile Examination Gloves manufactured by Niujian Technology Co., Ltd. (China). The tests themselves were conducted according to international standards (ASTM, ISO). The tests are prospective in the sense that they are performed on samples of the manufactured device to assess its compliance.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This document describes the testing of a physical medical device (nitrile gloves), not an AI algorithm. Therefore, concepts like "ground truth established by experts" are not applicable in the same way. The "ground truth" for these tests is defined by the technical specifications and limits set by the ASTM and ISO standards (e.g., a glove must have a tensile strength of X MPa, or less than Y mg of powder). The results are objectively measured against these numerical or qualitative criteria by laboratory technicians.
4. Adjudication Method
Not applicable, as this is laboratory testing of a physical product against predefined physical and chemical specifications, not subjective interpretation by multiple human readers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI or imaging device that would typically involve human readers.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a physical product (nitrile examination gloves), not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the performance of the Nitrile Examination Gloves is based on:
- Standard Specifications: Requirements outlined in established industry standards such as ASTM D6319, ASTM D5151, ASTM D6124, and ISO 10993-5, ISO 10993-10, ISO 10993-11. These standards define the acceptable physical dimensions, mechanical properties, freedom from holes, powder content, and biocompatibility profiles for such devices.
- Objective Measurements: Laboratory measurements and analyses conducted according to the specified test methodologies to determine if the device's properties fall within the defined acceptance criteria.
8. Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device. The document describes pre-market non-clinical testing of a physical product.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for a physical device like examination gloves. The "ground truth" for the performance characteristics of the gloves (e.g., minimum tensile strength, maximum powder content) is established through regulatory standards and scientific consensus embodied in the ASTM and ISO documents.
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