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510(k) Data Aggregation
(20 days)
The Powder Free Polymer Coated Latex Surgical Gloves, Sterile (Protein Labeling Claim) are made of natural rubber latex intended to be worn on the hand of healthcare personnel, operating room personnel and similar personnel to prevent contamination between the healthcare or similar personnel and the patient's body, fluids, waste, or environment.
The surgeon's glove is a device made of natural 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 Latex Surgical Gloves, Sterile (Protein Labeling Claim) meets all the requirements of ASTM standard D 3577 - 0151 and FDA 21 CFR 800.20.
The document describes the acceptance criteria and performance of Powder Free Polymer Coated Latex Surgical Gloves. It is a 510(k) summary for a medical device.
1. Table of Acceptance Criteria and Reported Device Performance:
| CHARACTERISTICS | STANDARDS | ACCEPTANCE CRITERIA (from Standards) | REPORTED DEVICE PERFORMANCE |
|---|---|---|---|
| Dimensions | ASTM D 3577 - 01E1 | As per ASTM D 3577 - 01E1 | Meets |
| Physical Properties | ASTM D 3577 - 01E1 | As per ASTM D 3577 - 01E1 | Meets |
| Freedom from pinholes | ASTM D 3577 - 01E1 & FDA 21 CFR 800.20 | As per ASTM D 3577 - 01E1 & FDA 21 CFR 800.20 | Meets |
| Powder-Free | ASTM D 6124 - 01 | < 2 mg/glove | < 2 mg/glove (Meets) |
| Protein Level | ASTM D 5712 – 99 | < 50 $\mu$g/g | < 50 $\mu$g/g (Meets) |
| Biocompatibility (Primary Skin Irritation in Rabbits) | As per standard (not explicitly named but implied) | Passes (Not a primary skin irritant) | Passes (Not a primary skin irritant) |
| Biocompatibility (Dermal Sensitization) | As per standard (not explicitly named but implied) | Passes (Not a contact sensitizer) | Passes (Not a contact sensitizer) |
Regarding the studies that prove the device meets acceptance criteria:
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials for effectiveness. The "study" here refers to the testing performed to show compliance with established standards.
2. Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample sizes used for each specific test (e.g., dimensions, pinholes, protein level). These tests are typically performed on a statistically representative sample of gloves from manufacturing lots, as outlined in the respective ASTM standards.
- Data Provenance: The tests are described as non-clinical performance data. The submitter is WRP Asia Pacific Sdn Bhd, located in Malaysia, suggesting the testing was likely conducted in Malaysia or by a contracted lab. The data is retrospective in the sense that it's reported from tests performed on already manufactured gloves.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to this type of device and study. The "ground truth" for these tests is defined by established scientific and engineering standards (ASTM and FDA regulations), not by expert consensus readings of, for example, medical images. The experts involved would be the engineers and quality control personnel performing the tests and interpreting the results against the defined standards. Their qualifications would be in metrology, chemistry, materials science, and quality assurance, not clinical expertise like radiology.
4. Adjudication method for the test set:
- This question is not applicable. Adjudication methods like "2+1" typically refer to reconciling disagreements among multiple human readers interpreting data. Here, the assessment involves objective measurements against predefined criteria in established 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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, not for a physical product like surgical gloves.
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 passive physical product and does not involve any algorithms or AI.
7. The type of ground truth used:
- The "ground truth" for the device's performance is established by the specified ASTM standards and FDA regulations for each characteristic (e.g., ASTM D 3577 for dimensions, physical properties, and freedom from pinholes; ASTM D 6124 for powder-free; ASTM D 5712 for protein level). For biocompatibility, the ground truth is determined by the results of standardized animal irritation and sensitization tests.
8. The sample size for the training set:
- This question is not applicable. There is no "training set" in the context of this device. A training set is used for machine learning models, which are not involved here. The data comes from quality control testing of manufacturing batches.
9. How the ground truth for the training set was established:
- This question is not applicable as there is no training set.
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