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510(k) Data Aggregation
(160 days)
The DISPOSABLE NITRILE EXAMINATION GLOVES (Powder free, Blue) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed device, DISPOSABLE NITRILE EXAMINATION GLOVES (Powder free, Blue) are disposable devices intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.
The proposed devices are Powder Free Nitrile Examination Gloves and includes variations of different size. The color of the proposed device is Blue.
The proposed device is not provided as sterilized The proposed device is made of Nitrile.
This document is a 510(k) Summary for a medical device called "DISPOSABLE NITRILE EXAMINATION GLOVES (Powder free, Blue)". It is an FDA submission to demonstrate substantial equivalence to a legally marketed predicate device.
The section providing acceptance criteria and performance data is "Table 5 Performance Test Results Summary" on pages 8-10.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D5151 | Testing for Freedom from holes | Freedom from holes AQL 2.5 | No water leakage inspected from 200 samples (This implies meeting or exceeding the AQL 2.5, as no holes were found). |
| ASTM D6124 | Determine the powder residue for powder free gloves | < 2.0 mg per glove | Residual Powder: Size S: Average 0.36 mg; Size M: Average 0.37 mg; Size L: Average 0.34 mg; Size XL: Average 0.32 mg. |
| ASTM D412, ASTM D573 | Testing for Physical property characteristics (Tensile Strength & Ultimate Elongation) | Before Aging: Tensile Strength: 14 MPa min.; Ultimate Elongation: 500% min.After Aging: Tensile Strength: 14 MPa min.; Ultimate Elongation: 400% min. | Before Aging: Tensile Strength: ≥ 19MPa; Ultimate Elongation: ≥ 500%.After Aging: Tensile Strength: ≥ 18 MPa; Ultimate Elongation: ≥ 472%. |
| ASTM D412, ASTM D3767 | Testing For physical dimensions specification | Length: 220 mm min. for S; 230 mm min. for M, L, XL.Width: 80±10 mm for S; 95±10 mm for M; 110±10 mm for L; 120±10 mm for XL.Cuff Thickness: ≥ 0.05 mm; Finger Thickness: ≥ 0.05 mm; Palm Thickness: ≥ 0.05 mm.All acceptance criteria above meet the requirements in Table 1 Dimensions and Tolerances of ASTM D6319. | Size S: Length: ≥ 223mm; Width: 85±2 (85-87) mm; Cuff Thickness: ≥ 0.06 mm; Palm Thickness: ≥ 0.07 mm; Finger Thickness: ≥ 0.10 mm.Size M: Length: ≥ 231 mm; Width: 95±3 (95-97) mm; Cuff Thickness: ≥ 0.06 mm; Palm Thickness: ≥ 0.07 mm; Finger Thickness: ≥ 0.10 mm.Size L: Length: ≥ 231mm; Width: 107±2 (105-109) mm; Cuff Thickness: ≥ 0.06 mm; Palm Thickness: ≥ 0.07 mm; Finger Thickness: ≥ 0.10 mm.Size XL: Length: ≥ 233mm; Width: 121±6 (115-127) mm; Cuff Thickness: ≥ 0.06 mm; Palm Thickness: ≥ 0.07 mm; Finger Thickness: ≥ 0.10 mm. |
| ISO 10993-11 | Evaluate the endpoint of Cytotoxicity for biocompatibility | The test article showed no evidence of cytotoxic potential from the extract. | The test article showed no evidence of systemic toxicity from the extract. (This appears to be a slight mismatch in the reported "Purpose" and "Results" cell content for ISO 10993-11, possibly an error in the document, as cytotoxicity and systemic toxicity are distinct endpoints. However, the result for systemic toxicity is provided.) |
| ISO 10993-10 | Evaluate the endpoint of irritant for biocompatibility | The response of the test article extract is negligible. | The test result showed that the response of the test article extract was categorized as negligible under the test condition. |
| ISO 10993-10 | Evaluate the endpoint of sensitization for biocompatibility | The test article showed no evidence of causing delayed dermal contact sensitization. | The test article showed no evidence of causing delayed dermal contact sensitization in the guinea pig. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Physical/Performance Tests:
- Freedom from holes (ASTM D5151): 200 samples (from "No water leakage is inspected form 200 samples").
- Other physical/performance tests (Tensile Strength, Elongation, Dimensions, Powder Residue): Not explicitly stated, but typically these tests use statistical sampling plans from the respective ASTM standards. For example, ASTM D6319 often references sampling procedures. The reported values are averages, implying multiple samples were tested for each size.
- Sample Size for Biocompatibility Tests (ISO 10993-series): Not explicitly stated, but standard protocols for these tests typically involve a specific number of animals/samples per test.
- Data Provenance: Not explicitly stated regarding country of origin or retrospective/prospective nature. However, the sponsor and submission correspondent are based in China, suggesting the testing was likely conducted there or overseen by labs affiliated with the manufacturer. The tests are bench tests ("Summary of Non-Clinical Testing"), so they are experimental in nature, not retrospective or prospective clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This document describes performance testing of a physical medical device (examination gloves) against established ASTM and ISO standards. It does not involve human interpretation of medical images or diagnoses that would require expert "ground truth" establishment in the way AI/ML devices do. Therefore, this section is not applicable for this type of device and testing. The "ground truth" here is the objective measurement against the specified standard criteria.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving subjective human assessment or consensus on, for example, diagnostic findings. The tests involve objective measurements and established physical/chemical testing protocols.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This is a 510(k) submission for examination gloves, which are Class I devices. It's a non-clinical bench test report to demonstrate substantial equivalence based on physical and safety characteristics. MRMC studies are typically performed for AI/ML-enabled diagnostic devices where human reader performance is a critical factor.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical product (gloves), not an algorithm or AI/ML software.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is defined by:
- Standard Specifications: Requirements outlined in ASTM D6319-19, ASTM D5151-19, ASTM D6124-17 (for physical performance and holes).
- Biocompatibility Standards: ISO 10993-10:2010 and ISO 10993-11:2017 (for irritation, sensitization, and systemic toxicity).
These are objective, measurable criteria established by recognized national and international standards bodies.
8. The Sample Size for the Training Set
Not applicable. This device is a manufactured product, not a software algorithm that requires a "training set" in the machine learning sense. The manufacturer's production processes are subject to Good Manufacturing Practices (GMP) and Quality System (QS) regulations, which ensure consistent product quality, but this isn't a "training set" like in AI/ML.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this device. The manufacturing process is controlled by quality systems rather than data-driven machine learning training.
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