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510(k) Data Aggregation
(73 days)
A patient examination glove is a disposable device intended for medical purposes that is worn upon the examiner's hands or finger to prevent contamination between patient and examiner (21CFR 880.6250)
Classified by FDA's General and Plastic Surgery Device panel as Class I, 21 CFR 880.6250, Powder-Free Nitrile Patient Examination Glove, 80LA, and meets all requirement of ASTM Standard D6319-10.
Device Acceptance Criteria and Performance Study Analysis:
1. Table of Acceptance Criteria and Reported Device Performance:
| Description | Acceptance Criteria (from predicate "Substantially equivalent") | Reported Device Performance (Dehai Nitrile Examination Gloves) |
|---|---|---|
| Material | Substantially equivalent to predicate | Nitrile Latex (NBR), Sulfur, Accelerator (ZDBC), Zinc Oxide, Potassium Hydroxide, Titanium Dioxide, and Stabilizer. (Deemed substantially equivalent to predicate's materials) |
| Before Aging: Tensile Strength (Mpa) | Substantially equivalent to predicate | 29.00 Mpa |
| Before Aging: Ultimate Elongations (%) | Substantially equivalent to predicate | 750% |
| After Aging: Tensile Strength (Mpa) | Substantially equivalent to predicate | 24.00 Mpa |
| After Aging: Ultimate Elongations (%) | Substantially equivalent to predicate | 700% |
| Overall Length on Medium Size (mm) | Substantially equivalent to predicate | Average over 230mm |
| Width of Palm on Medium Size (mm) | Substantially equivalent to predicate | Average 95mm |
| Film Thickness (mm) | Substantially equivalent to predicate | Average 0.073 mm |
| Finger Thickness (mm) | Substantially equivalent to predicate | Average 0.090 mm |
| Residual Powder (mg/glove) | Substantially equivalent to predicate (no more than 2 mg powder per glove based on ASTM D6124-06) | < 2 mg per glove, with no defective gloves found according to ASTM D6124-06. |
| Pinhole Results | Substantially equivalent to predicate (AQL 2.5) | Less than two defective gloves out of 125 pieces tested according to ASTM D5151-06. AQL 2.5 is met. |
| Biocompatibility: Primary Skin Irritation | Substantially equivalent to predicate (passes ISO 10993-10) | Passes ISO 10993-10 |
| Biocompatibility: Dermal Sensitization (Allergic Contact Dermatitis) | Substantially equivalent to predicate (passes ISO 10993-10) | Passes ISO 10993-10 |
Study Proving Device Meets Acceptance Criteria:
The study to prove the device met acceptance criteria was a comparison to a predicate device (K082598), Tangshan Zhonghong Pulin Group Co., Ltd. Synthetic Nitrile Patient Examination Gloves - Powder Free. The subject device, Dehai (Shandong) Medical Gloves, Co., Ltd. Nitrile Examination Gloves - Powder Free, Blue Color, was asserted to be "substantially equivalent" in all technological characteristics to the predicate device.
The study involved non-clinical tests based on ASTM-D-6319-10 for physical and dimensions testing, and the FDA 1000 ml. Water Fill Test for pinhole detection. Additionally, biocompatibility testing (Primary Skin Irritation and Skin Sensitization) was conducted based on ISO 10993-10.
2. Sample Sizes Used for the Test Set and Data Provenance:
- Pinhole Testing (Water Fill Test): AQL 2.5, Inspection Level I, sampling of 125 pieces (gloves were found to have less than two pinholes out of 125).
- Physical and Dimensions Testing (Tensile Strength, Elongation, Length, Width, Thickness): Inspection Level S-2 AQL 2.5. The specific sample size for each test within this category is not explicitly stated beyond "samplings of AQL 2.5."
- Residual Powder: According to ASTM D6124-06. The specific sample size is not explicitly stated.
- Biocompatibility (Primary Skin Irritation and Skin Sensitization): Not explicitly stated, but testing was conducted with results showing no primary skin irritant or sensitizing reactions.
Data Provenance: The data appears to be prospective as these tests were conducted on the subject device by the manufacturer (Dehai (Shandong) Medical Gloves, Co., Ltd.) to demonstrate substantial equivalence to the predicate device. The country of origin of the data is China, where the manufacturing company is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not mention the use of experts to establish ground truth for this type of medical device (examination gloves). The ground truth is established by standardized testing protocols (ASTM, ISO, FDA Water Fill Test) and comparisons against predefined criteria or a predicate device's characteristics. There's no indication of human expert interpretation for physical or chemical properties of the gloves.
4. Adjudication Method for the Test Set:
Not applicable. This type of device evaluation (physical and chemical properties of gloves) does not typically involve human adjudication in the way medical imaging or diagnostic devices might. Results are obtained directly from standardized tests and compared against numerical criteria or the properties of the predicate device.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not conducted. This type of study focuses on the effectiveness of human readers, typically in interpreting medical images or diagnostic information, which is not relevant for the evaluation of examination gloves.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
Not applicable. This device is a physical medical glove, not an algorithm or AI system. Therefore, standalone performance (without human-in-the-loop) is not a relevant concept for its evaluation.
7. Type of Ground Truth Used:
The ground truth used is primarily standardized test results and direct measurement data compared to established industry standards (ASTM-D-6319-10, ASTM D6124-06, ASTM D5151-06, ISO 10993-10) and the characteristics of a predicate device. It's a "pass/fail" or "meets specification" type of ground truth based on objective measurements rather than expert consensus on a diagnostic outcome or pathology.
8. Sample Size for the Training Set:
Not applicable. This device is a physical product and does not involve AI or machine learning, thus there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
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