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510(k) Data Aggregation
(59 days)
The Powder Free Vinyl Patient Examination Glove is a disposable device intended for medical purposes that is 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 colorless. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is nonsterile.
This document describes the premarket notification for the "Powder Free Vinyl Patient Examination Glove" (K210799). It is a Class I device and the submission focuses on demonstrating substantial equivalence to a predicate device (K163168).
Here's an analysis of the acceptance criteria and study data:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly defined by compliance with specific ASTM and ISO standards, and by showing equivalence to the predicate device, particularly regarding physical properties and biocompatibility.
| Acceptance Criteria (Standard/Requirement) | Reported Device Performance (Subject Device) |
|---|---|
| Physical Dimensions: | |
| Length (ASTM D5250) | 230mm (XS, S, M, L, XL) min |
| Width (ASTM D5250) | 75mm (XS), 85mm (S), 95mm (M), 105mm (L), 115mm (XL) $\pm$ 5mm |
| Finger Thickness (ASTM D5250) | 0.08mm min |
| Palm Thickness (ASTM D5250) | 0.08mm min |
| Physical Properties: | |
| Tensile Strength Before Aging (ASTM D5250) | 11MPa, min |
| Ultimate Elongation Before Aging (ASTM D5250) | 300% min |
| Tensile Strength After Aging (ASTM D5250) | 11MPa, min |
| Ultimate Elongation After Aging (ASTM D5250) | 300% min |
| Freedom from Holes (ASTM D5151) | Be free from holes when tested in accordance with ASTM D5151, AQL=2.5 |
| Powder Content (ASTM D6124) | < 0.02 mg per glove |
| Biocompatibility: | |
| Irritation (ISO 10993-10) | Under the conditions of the study, not an irritant |
| Sensitization (ISO 10993-10) | Under conditions of the study, not a sensitizer. |
| Cytotoxicity (ISO 10993-5) | Under conditions of the study, did not show potential toxicity to L-929 cells. |
| Labeling | Meets FDA's Requirement (Single use, powder free, device color, device name, glove size and quantity, Vinyl Examination Gloves, Non-Sterile information stated) |
| Material | Vinyl |
| Intended Use | Disposable device for medical purposes, worn on examiner's hands to prevent contamination between patient and examiner. |
2. Sample sized used for the test set and the data provenance
The document does not specify the exact sample sizes used for each test (e.g., number of gloves tested for tensile strength, pinholes, etc.). It only references compliance with the standards, which typically define sampling plans. The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). However, given the manufacturer's location in China, it is highly probable that the testing was conducted in China.
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 device is a medical glove, and its performance is evaluated against engineering and biological standards, not through expert human interpretation of medical data (like radiology images).
4. Adjudication method for the test set
This information is not applicable. Adjudication methods like "2+1" or "3+1" are typically used for establishing ground truth in expert-dependent diagnostic studies, not for the physical and biological testing of medical devices like gloves.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for AI-powered diagnostic tools, not for medical gloves. The device is not an AI-assisted tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study was not applicable/conducted in the context of an algorithm or AI. The performance studies conducted were on the physical and biological properties of the glove itself.
7. The type of ground truth used
The "ground truth" for this device's performance is established by compliance with recognized industry standards and regulatory requirements. This includes:
- Engineering Standards: ASTM D5250 (Standard Specification for Poly (vinyl chloride) Gloves for Medical Application), ASTM D5151 (Standard Test Method for Detection of Holes in Medical Gloves), ASTM D6124 (Standard Test Method for Residual Powder on Medical Gloves).
- Biocompatibility Standards: ISO 10993-10 (Tests For Irritation And Skin Sensitization), ISO 10993-5 (Tests For In Vitro Cytotoxicity).
- Predicate Device Equivalence: Demonstrating that the subject device performs similarly or better than a legally marketed predicate device (K163168) in key functional and safety attributes.
8. The sample size for the training set
This information is not applicable. The device is a physical product (medical glove), not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable. As explained above, there is no AI algorithm or training set for this device.
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