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510(k) Data Aggregation
(111 days)
Sterile Latex Surgical Gloves Powder Free is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
The proposed device, Sterile Latex Surgical Gloves Powder Free with protein content labeling claim of 50 µg/ dm² or less per glove of extractable protein is a sterile and disposable medical glove intended to be worn by operating room personnel to protect a surgical wound from contamination. The proposed device is made of natural rubber latex, as per standard ASTM D3577-2019, Standard Specification for Rubber Surgical Gloves. The classification is: Type I - gloves compounded primarily from natural rubber latex. The proposed device is Sterile Latex Surgical Gloves Powder Free, and variants of different sizes. All variants share the same natural color (No color is added). The proposed device is sterilized using Gamma Radiation method to achieve the Sterility Assurance Level (SAL) of 10 and place in a sterility maintained package to ensure a shelf life of 3 years.
The provided text describes the acceptance criteria and study results for "Sterile Latex Surgical Gloves Powder Free." Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Specification as per ASTM D3577-2019) | Reported Device Performance (Average value of subject device) | Complied with Standard? |
|---|---|---|---|
| Dimensions | |||
| Length (all sizes) | Min 265mm | 383mm (Size 6), 385mm (Size 6.5), 388mm (Size 7), 390mm (Size 7.5), 392mm (Size 8), 394mm (Size 8.5), 396mm (Size 9) | Yes |
| Width (Size 6) | 76+/-6mm | 74mm | Yes |
| Width (Size 6.5) | 83+/-6mm | 86mm | Yes |
| Width (Size 7) | 89+/-6mm | 92mm | Yes |
| Width (Size 7.5) | 95+/-6mm | 98mm | Yes |
| Width (Size 8) | 102+/-6mm | 105mm | Yes |
| Width (Size 8.5) | 108+/-6mm | 110mm | Yes |
| Width (Size 9) | 114+/-6mm | 116mm | Yes |
| Finger Thickness (all sizes) | Min 0.10mm | 0.21mm | Yes |
| Palm Thickness (all sizes) | Min 0.10mm | 0.16mm | Yes |
| Cuff Thickness (all sizes) | Min 0.10mm | 0.12mm | Yes |
| Tensile Strength | |||
| Before aging (all sizes) | 24Mpa minimum | 28.55Mpa | Yes |
| After aging @ 70°±2C for 166±2 hr (all sizes) | 18Mpa minimum | 23.48Mpa | Yes |
| Ultimate Elongation | |||
| Before aging (all sizes) | 750% minimum | 870% | Yes |
| After aging @ 70°±2C for 166±2 hr (all sizes) | 560% minimum | 731% | Yes |
| Stress at 500% | |||
| Before aging (all sizes) | 5.5 MPa Max | 5.1 Mpa | Yes |
| Pinhole AQL | |||
| Before aging (all sizes) | Max 1.5 | 1.0 | Yes |
| After aging @ 70°C for 7 days (all sizes) | Max 1.5 | 1.0 | Yes |
| Powder Residue | < 2 mg/Glove | 0.40 mg/Glove | Yes (Implied, as 0.40 < 2) |
| Protein Content | ≤ 50 µg/ dm² | 50 µg/ dm² | Yes |
| Biocompatibility - Skin Irritation | Under the condition of study not an irritant | Under the condition of study not an irritant | Yes |
| Biocompatibility - Skin Sensitization | Under the conditions of the study not a sensitizer | Under the conditions of the study not a sensitizer | Yes |
| Biocompatibility - In vitro Cytotoxicity | Under the conditions of study non cytotoxic | Under the conditions of the study cytotoxic. | No (Did not meet "non cytotoxic" criteria, but similarity to predicate allowed) |
| Biocompatibility - Systemic Toxicity | Under the conditions of study the device extracts do not pose a systemic toxicity concern | Under the conditions of study the device extracts do not pose a systemic toxicity concern | Yes |
| Bacterial Endotoxin | <20EU/pair of gloves | <20EU/pair of gloves | Yes |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for each specific test (e.g., how many gloves were tested for length, tensile strength, etc.). It refers to meeting the "acceptance criteria of the standard" (ASTM D3577-2019, ASTM D5151-2019, ASTM D6124-06, ASTM D5712-15) which would define the sampling plans.
The data provenance is not explicitly stated as "country of origin" for the testing or whether it was retrospective/prospective. However, the applicant is "Pentavest Holdings Sdn Bhd" located in Melaka, Malaysia, suggesting the testing was performed, or overseen, with connections to Malaysia. The testing, described as "Bench tests," typically refers to laboratory-based evaluations of the device itself rather than clinical data from human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to the submitted document. The "ground truth" for this medical device (Sterile Latex Surgical Gloves) is established through adherence to recognized international and national consensus standards (e.g., ASTM, ISO, USP) for physical, chemical, and biological properties, not by expert consensus in diagnostic imaging or clinical assessment. The standards themselves define the acceptable parameters.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This type of adjudication method is used in studies where human readers interpret data, such as medical images. For device performance testing against manufacturing and performance standards, the results are quantitative and compared directly to specified limits.
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 document pertains to the regulatory submission for surgical gloves, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document is for surgical gloves, not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is based on established consensus standards (ASTM, ISO, USP). These standards define the acceptable physical, chemical, and biological properties and performance characteristics for rubber surgical gloves. Compliance with these standards serves as the evidence that the device is safe and effective for its intended use.
8. The sample size for the training set
Not applicable. This is not an AI or machine learning device; therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth for it to be established.
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