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510(k) Data Aggregation
(18 days)
The surgeon's glove is a device made of synthetic rubber latex intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.
The Powder Free, Polymer Coated Polyisoprene Surgical Gloves, Sterile, Coated with Aloe Vera, Natural colour or Turquoise (Blue/Green) colour are made of synthetic rubber lates intended to be worn by surgeons and/or operating room personnel to protect a surgical wound from contamination.
The provided document describes the acceptance criteria and performance of Powder Free, Polymer Coated Polyisoprene Surgical Gloves, Sterile, Coated with Aloe Vera, Natural colour or Turquoise (Blue/Green) colour. The study detailed is aimed at demonstrating substantial equivalence to a legally marketed predicate device (K032942) for 510(k) clearance.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standards) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 3577 - 01aE2 | Meets |
| Physical Properties | ASTM D 3577 - 01aE2 | Meets |
| Freedom from pinholes | ASTM D 3577 - 01aE2 & FDA 21 CFR 800.20 | Meets |
| Powder Residual | ASTM D 6124 - 01 | Meets (< 2 mg/glove) |
| Biocompatibility | Primary Skin Irritation in Rabbits (Test) | Passes (Not a primary skin irritant) |
| Dermal Sensitization (Test) | Passes (Not a contact sensitizer) |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes used for testing each characteristic. It refers to compliance with ASTM standards, which would typically specify sample sizes for testing.
The data provenance is not explicitly mentioned, but the manufacturer is WRP Asia Pacific Sdn Bhd, located in Malaysia. The testing was conducted to meet US FDA regulations (21 CFR 800.20) and ASTM standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a surgical glove, and its performance is evaluated against engineering and biological standards, not against interpretation by medical experts.
4. Adjudication method for the test set
Not applicable. As described above, performance is evaluated against objective 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
Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not a software algorithm.
7. The type of ground truth used
The ground truth is established by objective engineering and biological standards and test methods.
- Engineering Standards: ASTM D 3577 - 01aE2 for dimensions, physical properties, and freedom from pinholes; ASTM D 6124 - 01 for powder residual.
- Regulatory Standard: FDA 21 CFR 800.20 for freedom from pinholes.
- Biological Testing: Primary Skin Irritation in Rabbits and Dermal Sensitization tests for biocompatibility.
8. The sample size for the training set
Not applicable. There is no training set for this type of device (surgical glove).
9. How the ground truth for the training set was established
Not applicable. There is no training set.
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