Search Results
Found 1 results
510(k) Data Aggregation
(192 days)
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. These gloves are designed for single use only and should be disposed after use.
The powder free nitrile examination glove is manufactured from Nitrile rubber. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves without using any lubricant such as powder on the glove surface. The glove is ambidextrous, i.e., can be worn on right hand or left hand and it is a single use device.
The provided document describes the acceptance criteria and results of a study for the "Black Nitrile Powder Free Patient Examination Glove, Non Sterile" (K212916).
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Test Method | Acceptance Criteria | Reported Device Performance | Status |
|---|---|---|---|
| Physical Properties | |||
| Tensile Strength (Before aging) | Min 14.0 MPa | 30.9 Mpa | Pass |
| Tensile Strength (After aging) | Min 14.0 MPa | 34.2 Mpa | Pass |
| Ultimate Elongation (Before aging) | Min 500% | 583% | Pass |
| Ultimate Elongation (After aging) | Min 400% | 538% | Pass |
| Watertight | Sample size: 315 pcs, Inspection level: G1, AQL: 1.5, Acceptance No. 10 | 0 pieces with leaks (for a batch size of 150,001 to 500,000, where 315 pcs were drawn for testing). | Pass |
| Dimension (Length) | Min 240 mm (for all sizes) | X-Small: 251 mm, Small: 250 mm, Medium: 251 mm, Large: 250 mm, X-Large: 249 mm | Pass |
| Dimension (Palm Width) | X-Small: 70 ± 10 mm, Small: 80 ± 10 mm, Medium: 95 ± 10 mm, Large: 110 ± 10 mm, X-Large: 120 ± 10 mm | X-Small: 78.0 mm, Small: 88.0 mm, Medium: 98.0 mm, Large: 108 mm, X-Large: 118 mm | Pass |
| Dimension (Thickness - Finger) | Min 0.05 mm | 0.10 mm (for all sizes) | Pass |
| Dimension (Thickness - Palm) | Min 0.05 mm | 0.07 mm (for all sizes) | Pass |
| Residual Powder | Less than 2 mg per glove | 0.20 mg/glove (Sample size: 5 pcs) | Pass |
| Biocompatibility - Primary Skin Irritation | "Passes" (Predicate result), "Negligible" irritant response (Subject device) | The test material did not cause an irritant response. The Primary Irritant Response Category is deemed 'Negligible'. | Similar |
| Biocompatibility - Dermal Sensitization | "Passes" (Predicate result), "No skin sensitization effect" (Subject device) | The test material did not produce a skin sensitization effect in the guinea pigs. | Similar |
| Biocompatibility - Cytotoxicity | "Passes" (Predicate result) | The test material demonstrated a cytotoxic effect under the condition of this study. Grade 2 for 6.25% & 12.5%, Grade 4 for 25%, 50% & 100%. (Note: Additional test i.e. Acute Systemic Toxicity was tested, indicating a deviation from the predicate's implied acceptance but mitigated by further testing) | Different (But additional test performed) |
| Biocompatibility - Acute Systemic Toxicity | Not Applicable (Predicate result) | The test item did not induce any systemic toxicity in Swiss albino mice. | Different |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Physical Properties: The document doesn't explicitly state the sample size for individual physical properties tests, but generally refers to conforming to ASTM D412.
- Watertight: The sample size for the watertight test was 315 pieces from a batch size of 150,001 to 500,000.
- Dimension: The document doesn't specify a sample size for dimensional measurements per glove size, but mentions measurement as per ASTM D6319.
- Residual Powder: The sample size for residual powder was 5 pieces.
- Biocompatibility: The sample size for biocompatibility tests is not explicitly stated in the provided text for each specific test, but they generally follow ISO and CPSC standards, which would define appropriate sample sizes for these types of biological evaluations. For Dermal Sensitization, "guinea pigs" are mentioned, and for Acute Systemic Toxicity, "Swiss albino mice" are mentioned, implying animal testing was conducted.
The data provenance is not explicitly stated as "retrospective" or "prospective." However, given that this is a 510(k) submission for a new device claiming substantial equivalence to a predicate, the tests are conducted on the subject device (K212916) in order to demonstrate its performance. The manufacturer, Rimba Glove Sdn Bhd, is located in Perak, Malaysia. The testing would have been conducted to support this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This device is a patient examination glove, a non-AI/software medical device. Therefore, the concept of "ground truth established by experts" in the context of diagnostic interpretation (like in imaging AI) is not applicable here. The "ground truth" for the performance tests (e.g., tensile strength, watertightness, dimensions, powder content, biocompatibility) is established by adherence to recognized international and national standards (ASTM, ISO), and the results are quantifiable measurements or observed biological responses as determined by standard laboratory practices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a diagnostic device involving human interpretation that would require adjudication. The test methods are objective, standardized laboratory measurements and biological assays.
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 a physical medical device (examination glove) and does not involve human readers, AI, or diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device and does not involve algorithms or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on:
- Standardized Test Methods: Adherence to established industry standards like ASTM (e.g., ASTM D412, D5151, D3767, D6124, D6319) and ISO (e.g., ISO 10993 for biocompatibility).
- Quantifiable Measurements: Physical properties (tensile strength, elongation, dimensions, powder residue) are measured directly.
- Biological Responses: Biocompatibility tests (skin irritation, sensitization, cytotoxicity, systemic toxicity) are assessed based on scientific protocols for animal and in vitro tests, adhering to ISO 10993 and CPSC guidelines.
8. The sample size for the training set
Not applicable. This is a physical medical device and does not involve AI or machine learning models that require a training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI model, no ground truth was established for it.
Ask a specific question about this device
Page 1 of 1