Search Results
Found 1 results
510(k) Data Aggregation
(66 days)
The Disposable Nitrile Examination Gloves are disposable devices intended for medical purposes that are worn on the examiner's hands to prevent contamination between patient and examiner.
The subject device is powder free nitrile examination gloves. The subject device is in blue color. It can be available in four specifications: S,M,L and XL. The subject device is non-sterile.
The provided document is a 510(k) Premarket Notification for Disposable Nitrile Examination Gloves. It details the non-clinical testing performed to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study findings based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| ASTM D6319 | Physical Dimensions Test | Length(mm): S:≥220; M/L/XL:≥230; Width(mm): S: 80±10; M: 95±10; L: 110±10; XL: 120±10; Thickness (mm): Finger: ≥0.05, Palm: ≥0.05 | Length: S: >220/Pass; M/L/XL: >230/Pass; Width: S: 82-88 /Pass; M: 95-98/ Pass; L: 106-111/ Pass; XL:111-115/ Pass; Finger Thickness: 0.13-0.15/Pass; Palm Thickness: 0.09-0.12/Pass |
| ASTM D5151 | Watertightness Test for Detection of Holes | Meet the requirements of ASTM D5151 AQL=2.5 | 0/125/Pass (This implies 0 holes found in 125 samples, meeting the AQL of 2.5) |
| ASTM D6124 | Powder Content | Meet the requirements of ASTM D6124 << 2.0mg/glove | S:0.13 mg/glove; M:0.13 mg/glove; L:0.16 mg/glove; XL:0.11 mg/glove (All below 2.0mg/glove) |
| ASTM D412 | Physical properties | Before Aging: Tensile Strength ≥14MPa, Ultimate Elongation ≥500%; After Aging: Tensile Strength ≥14MPa, Ultimate Elongation ≥400% | Before Aging: Tensile Strength: 20-34/Pass (vs ≥14MPa); Ultimate Elongation: 521-570/Pass (vs ≥500%); After Aging: Tensile Strength: 15-25/Pass (vs ≥14MPa); Ultimate Elongation: 470-545/Pass (vs ≥400%) |
| ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under the condition of the study, the device extract showed cytotoxic / fail. (Note: This is a failure, indicating it did not meet the non-cytotoxic criterion.) Correction: The sentence in the document says "Under conditions of the study, device extract is cytotoxic" for the predicate in the comparison table, and then "Under the condition of the study, the device extract showed cytotoxic / fail" in the results. This indicates that their device extract was indeed cytotoxic according to the test results and it failed this specific criterion as reported. From the context below, it seems the failure was acknowledged and the device was still cleared based on overall safety. (In 510k submissions, sometimes minor failures are accepted if compensated by other factors or if the risk is deemed acceptable for the intended use.) |
| ISO 10993-11 | Acute 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 size used for the test set and the data provenance
- Test Set Sample Sizes:
- ASTM D5151 (Watertightness): 125 samples (stated as "0/125/Pass")
- ASTM D6319 (Dimensions), ASTM D6124 (Powder Content), ASTM D412 (Physical Properties): Specific sample sizes for each glove size (S, M, L, XL) are not explicitly stated, but the results are presented for each size.
- Biocompatibility (ISO 10993-5, -10, -11): Not explicitly stated, but these typically involve a certain number of replicates and control groups for in vitro or in vivo tests.
- Data Provenance: The document implies that the testing was conducted by or for the manufacturer, Jiangxi Handspro Products Solutions CO., LTD. in China. The data is from non-clinical testing designed to evaluate the physical and biological characteristics of the device. It is prospective in the sense that these tests were conducted intentionally for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable for this type of device and study. The "ground truth" for the non-clinical testing of medical gloves (like dimensions, physical properties, or biocompatibility) is established by adherence to recognized international and national standards (e.g., ASTM, ISO). There are no human experts "establishing ground truth" in the way a radiologist would for medical imaging. The standards themselves define the test methods and acceptance criteria.
4. Adjudication method for the test set
This is not applicable for non-clinical performance testing. Adjudication methods like "2+1" are relevant for clinical studies or expert review processes where subjective interpretations might differ. For objective measurements against established standards, the results are determined by the test execution itself.
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
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or screening devices, not for disposable examination gloves.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. This device is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" is defined by established international and national consensus standards (ASTM D6319, ASTM D5151, ASTM D6124, ASTM D412, ISO 10993-5, ISO 10993-10, ISO 10993-11). These standards specify the methods for measurement and the acceptable ranges for physical properties and biological responses.
8. The sample size for the training set
Not applicable. This device is a physical medical product (disposable gloves), not a machine learning or AI algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As stated above, this device does not utilize a training set.
Ask a specific question about this device
Page 1 of 1