Search Results
Found 1 results
510(k) Data Aggregation
(86 days)
A nitrile patient examination glove is a disposable device made of nitrile rubber intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.
White Nitrile Powder-Free Patient Examination Glove, Non-Sterile is manufactured from nitrile rubber. Innersurface 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 or silicone on the glove surface. The glove is ambidextrous, i.e., can be worn on right or left hand.
The provided document describes the acceptance criteria and performance data for the "White Nitrile Powder-Free Patient Examination Glove, Non Sterile" (K222713). This medical device is a patient examination glove and the testing performed aligns with engineering and material specifications, rather than AI/software performance. Therefore, many of the requested fields related to AI/ML device studies (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, and training set information) are not applicable to this submission.
Here's the relevant information extracted from the document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Standard / Test Method | Acceptance Criteria | Reported Device Performance (K222713) | Status |
|---|---|---|---|---|
| Physical Properties | ASTM D412 (Vulcanized Rubber and Thermoplastic Elastomers—Tension) | Tensile Strength: Before aging: Min 14.0 MPa; After aging: Min 14.0 MPa Ultimate Elongation: Before aging: Min 500%; After aging: Min 400% | Tensile Strength: Before aging: XS – 28.8 MPa, S – 28.6 MPa, M – 28.9 MPa, L – 28.1 MPa, XL – 28.7 MPa After aging: XS – 30.8 MPa, S – 31.1 MPa, M – 31.8 MPa, L – 31.9 MPa, XL – 30.8 MPa Ultimate Elongation: Before aging: XS – 540%, S – 540%, M – 530%, L – 540%, XL – 540% After aging: XS – 460%, S – 480%, M – 480%, L – 480%, XL – 480% | Pass |
| Dimension | ASTM D3767 (Rubber—Measurement of Dimensions) | Length: Min 240 mm Width: XS: 70 ± 10 mm S: 80 ± 10 mm M: 95 ± 10 mm L: 110 ± 10 mm XL: 120 ± 10 mm Thickness (Finger & Palm): Min 0.05 mm | Length: XS: 248 mm, S: 245 mm, M: 244 mm, L: 248 mm, XL: 244 mm Width: XS: 75 mm, S: 85 mm, M: 95 mm, L: 106 mm, XL: 116 mm Thickness: Finger: 0.09 mm (all sizes) Palm: 0.06 mm (all sizes) | Pass |
| Watertight | ASTM D5151 (Detection of Holes in Medical Gloves) | Sample size: 315 pcs (Inspection level G1, AQL 1.5, Acceptance No. 10) | Results for 315 pieces (Batch size 150,001 to 500,000): XS: 1 piece with leaks S: 2 pieces with leaks M: 2 pieces with leaks L: 4 pieces with leaks XL: 3 pieces with leaks (All within the acceptance criteria of 10 leaks or less for the sample size.) | Pass |
| Residual Powder | ASTM D6124 (Residual Powder on Medical Gloves) | Less than 2 mg per glove (< 2 mg/glove) | Results (5 pcs sample size): XS: 0.24 mg/glove S: 0.28 mg/glove M: 0.34 mg/glove L: 0.32 mg/glove XL: 0.38 mg/glove | Pass |
| Biocompatibility | ISO 10993 Part 10 (Irritation and Sensitization), 16 CFR Part 1500 (Consumer Product Safety Commission) | Primary Skin Irritation: Non-irritant or non-sensitizer Dermal Sensitization: Non-irritant or non-sensitizer | Primary Skin Irritation: Test material did not cause an irritant response; deemed 'Negligible' Dermal Sensitization: Test material did not produce a skin sensitization effect in guinea pigs | Pass |
| Biocompatibility | ISO 10993 Part 11 (Systemic Toxicity) | No acute systemic toxicity | Test item did not induce any acute systemic toxicity in Swiss albino mice. | Pass |
2. Sample size used for the test set and the data provenance:
- Physical Properties (Tensile Strength, Elongation): Not explicitly stated how many gloves were tested for each size, but results are shown for each of the 5 sizes (XS, S, M, L, XL).
- Dimension (Length, Width, Thickness): Not explicitly stated how many gloves were tested for each size, but results are shown for each of the 5 sizes (XS, S, M, L, XL).
- Watertight: A sample size of 315 pieces per batch was used, adhering to a single sampling plan G1 for a batch size of 150,001 to 500,000.
- Residual Powder: A sample size of 5 pieces per size was used.
- Biocompatibility: The standard test methods (ISO 10993-10 for irritation/sensitization, ISO 10993-11 for systemic toxicity) imply specific animal models (e.g., guinea pigs for sensitization, Swiss albino mice for systemic toxicity), but the exact number of animals is not detailed in this summary.
Data Provenance: The document does not specify the country of origin for the test data, nor does it explicitly state whether the studies were retrospective or prospective, although laboratory testing like this is typically prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. The ground truth for device performance in this context is established by adherence to recognized international technical standards (ASTM, ISO) and specific criteria outlined for physical, chemical, and biological properties, not by expert consensus on clinical cases.
4. Adjudication method for the test set:
This is not applicable as the tests are objective measurements against defined standards.
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:
This is not applicable as the device is a patient examination glove, not an AI/ML diagnostic or assistive tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is a patient examination glove, not an AI/ML algorithm.
7. The type of ground truth used:
The ground truth used for this device is based on objective measurements and laboratory testing results compared against established international consensus standards (ASTM, ISO) for physical properties, dimensions, watertight integrity, residual powder, and biocompatibility.
8. The sample size for the training set:
This is not applicable as the device is a patient examination glove and does not involve an AI/ML model that requires training data.
9. How the ground truth for the training set was established:
This is not applicable.
Ask a specific question about this device
Page 1 of 1