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510(k) Data Aggregation
(82 days)
The Vinyl Patient 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 vinyl patient examination gloves. The subject device is clear. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is nonsterile.
This document is a 510(k) Premarket Notification for Vinyl Patient Examination Gloves, asserting substantial equivalence to a predicate device (K163168). The acceptance criteria and supporting studies are primarily focused on physical and chemical performance standards for medical gloves, rather than AI/algorithm-based criteria.
Here's a breakdown based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard Reference) | Reported Device Performance (Subject Device) | Predicate Device Performance (K163168) | Comparison |
|---|---|---|---|
| Physical Dimensions (ASTM D5250) | |||
| Length, mm (min) | 230 (XS, S, M, L, XL) | 230 (XS, S), 235 (M), 245 (L, XL) | Different lengths for M, L, XL sizes, but all "meet the requirements of ASTM D5250" |
| Width, mm (±5) | 78 (XS), 85 (S), 95 (M), 105 (L), 115 (XL) | 80 (XS), 85 (S), 95 (M), 105 (L), 115 (XL) | Different for XS width, but all "meet the requirements of ASTM D5250" |
| Finger Thickness, mm (min) | 0.08 | 0.05 | Different, but subject device meets higher minimum. "Meet the requirements of ASTM D5250" |
| Palm Thickness, mm (min) | 0.08 | 0.08 | Same |
| Physical Properties (ASTM D5250) | |||
| Before Aging Tensile Strength | 11 MPa, min | 15 MPa, min | Different, but subject device meets ASTM D5250 requirements ["do not raise any new safety or performance questions"] |
| Before Aging Ultimate Elongation | 300% min | 380% min | Different, but subject device meets ASTM D5250 requirements ["do not raise any new safety or performance questions"] |
| After Aging Tensile Strength | 11 MPa, min | 15 MPa, min | Different, but subject device meets ASTM D5250 requirements ["do not raise any new safety or performance questions"] |
| After Aging Ultimate Elongation | 300% min | 380% min | Different, but subject device meets ASTM D5250 requirements ["do not raise any new safety or performance questions"] |
| Freedom from Holes (ASTM D5151) | Be free from holes when tested in accordance with ASTM D5151 AQL=2.5 | Be free from holes when tested in accordance with ASTM D5151 AQL=2.5 | Same |
| Powder Content (ASTM D6124) | < 0.01 mg per glove. meets the requirements of ASTM D6124 | Meet the requirements of ASTM D6124 | Similar (specific value provided for subject device) |
| Biocompatibility (ISO 10993-10, ISO 10993-5) | |||
| Irritation | Under the conditions of the study, not an irritant. Comply with ISO10993-10. | Comply with ISO10993-10 | Same |
| Sensitization | Under conditions of the study, not a sensitizer. Comply with ISO10993-10. | (Implied by ISO10993-10 compliance) | Same |
| Cytotoxicity | Under conditions of the study, did not show potential toxicity to L-929 cells. Comply with ISO10993-5. | Not provided | Different (predicate did not provide specific data, but is generally expected to have met this if it met ISO 10993 standards). Subject device demonstrated compliance. |
| Material | Vinyl | Vinyl | Same |
| Colorant | Clear | White, Blue, Yellow | Different, but biocompatibility testing confirmed no safety issues. |
| Labeling Information | Single use, powder free, device color, device name, glove size and quantity, Vinyl Examination Gloves, Non-Sterile | Single use, powder free, device color, device name, glove size and quantity, Vinyl Examination Gloves, Non-Sterile | Similar |
The study that proves the device meets the acceptance criteria is detailed in Section 8.0, "Discussion of Non-clinical and Clinical Test Performed," and Section 7.0 "Technological Characteristic Comparison Table" of the 510(k) submission.
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test (e.g., how many gloves were tested for tensile strength or freedom from holes). Instead, it refers to industry standards (ASTM D6124, ASTM D5151, ASTM D5250) which dictate the appropriate sample sizes and testing methodologies.
- Provenance: The document does not explicitly state the country of origin or whether the specific test data was retrospective or prospective. However, the manufacturer is Jiangxi Shengda Medical Technology Co., Ltd. in China, implying the testing was likely conducted in China or by labs accredited to perform testing for devices manufactured in China according to international standards. As these are non-clinical (laboratory) tests, the distinction between retrospective and prospective is less relevant than for clinical studies.
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 to this type of device and study. The "ground truth" for medical gloves is established by objective measurements against established technical standards (like ASTM and ISO), not by expert consensus or interpretations of medical images/data. The tests are for objective physical, chemical, and biological properties, not for diagnostic accuracy or human interpretation.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are used in studies where there is subjective interpretation (e.g., medical image reading) to establish a consensus ground truth. For the physical and chemical testing of medical gloves, the results are typically objective measurements against a defined standard.
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 device is a medical glove, not an AI-assisted diagnostic or therapeutic device. Therefore, the concept of "human readers improve with AI" does not apply.
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 a medical glove, not an algorithm or AI system.
7. The type of ground truth used
The "ground truth" for the performance evaluation of these medical gloves is based on established national and international standards for medical gloves:
- ASTM D5250-19: Standard Specification for Poly (vinyl chloride) Gloves for Medical Application.
- ASTM D5151-19: Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6124-06 (Reapproved 2017): Standard Test Method for Residual Powder on Medical Gloves.
- ISO 10993-10:2010: Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
- ISO 10993-5:2009: Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity.
These standards define the acceptable range or threshold for specific physical properties (e.g., tensile strength, elongation, dimensions), the methodology for detecting defects (holes), the limits for residual powder, and the requirements for biocompatibility (irritation, sensitization, cytotoxicity).
8. The sample size for the training set
This information is not applicable. This is not an AI/machine learning device, so there is no "training set" in the conventional sense. The manufacturing process and quality control would involve statistical sampling, but this is distinct from training an algorithm.
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for this type of medical device submission.
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