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510(k) Data Aggregation
(138 days)
Surgeon's glove (powdered) is a sterile medical device made of natural latex intended to be worn by operating room personnel to protect a surgical wound from contamination and is powdered with absorbable dusting powder USP corn starch as the donning lubricant.
Class I Powdered Surgical Glove 79KGO that meets all the requirements of ASTM D3577.
This is an analysis of a 510(k) summary for a medical device, specifically powdered surgeon's gloves. The document primarily focuses on demonstrating substantial equivalence to a predicate device through meeting established performance standards.
Here's the breakdown of acceptance criteria and device performance based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (ASTM D3577 & other standards) | Reported Device Performance (Brightway Gloves Pvt. Ltd.) | Meets Criteria? |
|---|---|---|---|
| Dimensions | |||
| Length (5 ½) | 245 mm minimum | 270-272 mm | Yes |
| Length (6 to 9) | 265 mm minimum | 270-272 mm | Yes |
| Width (5 ½) | 70 +/- 6 mm | 68 mm | Yes (Within range) |
| Width (6) | 76 +/- 6 mm | 73 mm | Yes (Within range) |
| Width (6 ½) | 83 +/- 6 mm | 79 mm | Yes (Within range) |
| Width (7) | 99 +/- 6 mm | 87 mm | Yes (Within range) |
| Width (7 ½) | 95 +/- 6 mm | 92 mm | Yes (Within range) |
| Width (8) | 105 +/- 6 mm | 103 mm | Yes (Within range) |
| Width (8 ½) | 108 +/- 6 mm | 106 mm | Yes (Within range) |
| Width (9) | 114 +/- 6 mm | 112 mm | Yes (Within range) |
| Thickness (Cuff, Palm, Fingertip) | 0.1 mm minimum | 0.12 mm (cuff), 0.16 mm (palm), 0.19 mm (fingertip) | Yes |
| Physical Properties | |||
| Tensile Strength (Before Ageing) | 24 mpa | 27 mpa | Yes |
| Elongation at break % (Before Ageing) | 750% | 850% | Yes |
| Modulus at 500 % elongation (Before Ageing) | 5.5 mpa (max) | 3 mpa | Yes |
| Tensile Strength (After Ageing) | 18 mpa min | 20 mpa | Yes |
| Elongation at break % (After Ageing) | 560% min | 750% | Yes |
| Performance Requirements | |||
| Sterility | As per USP | As per IP (Indian Pharmacopeia) | Yes (Assumed equivalent in practice) |
| Freedom from Holes (AQL) | 1.5 | 1.5 (S4 inspection level) | Yes |
| Dimension (AQL) | 4 | 4 (S2 inspection level) | Yes |
| Physical Property (AQL) | 4 | 4 (S2 inspection level) | Yes |
| Other Properties | |||
| Powder Content | 150 mg/glove max (on Medium size) | 120 +/- 20 mg on size 8 (Implicitly meets for medium if met for size 8) | Yes |
| Protein Content | 200 ppm (max) (FDA Requirement) | 80 +/- 20 ppm | Yes |
| Moisture Content | No value fixed (FDA) | 0.8% max | N/A (Device provides stricter internal limit) |
| Biocompatibility | Biologically Compatible (FDA) | Biologically Compatible | Yes |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes (e.g., number of gloves) used for each specific test. It indicates "BGPL Value" for measured parameters, suggesting the company conducted these tests. The provenance of the data is from Brightway Gloves Pvt. Ltd., located in Tamil Nadu, India. The tests appear to be a retrospective comparison against established standards (ASTM D3577 and FDA requirements) rather than a prospective clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided. The "ground truth" for this device is based on compliance with standardized measurements and performance specifications (ASTM D3577, USP, FDA requirements). These standards are developed by expert committees, but the submission does not detail the involvement of specific experts in establishing the ground truth for this particular test set.
4. Adjudication Method for the Test Set
This is not applicable as the compliance is based on objective, standardized measurements against published technical specifications rather than subjective expert assessment requiring adjudication.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or interpretive devices where human interpretation of images or data is involved. Surgeon's gloves are a physical product, and their performance is evaluated through material science and physical property tests, not through human reader interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is not applicable. The device is a physical product (surgeon's glove), not an algorithm or AI system. Its performance is inherent to the product itself, not mediated by an AI.
7. Type of Ground Truth Used
The ground truth used is based on established industry standards and regulatory requirements, specifically:
- ASTM D3577: Standard Specification for Rubber Surgical Gloves.
- USP (United States Pharmacopeia) / IP (Indian Pharmacopeia): For sterility testing.
- FDA Requirements: For protein content, moisture content (though no fixed value), and inherent biocompatibility.
These are specifications for physical and chemical properties, not clinical outcomes or expert consensus on a diagnostic interpretation.
8. Sample Size for the Training Set
This is not applicable. As a physical medical device (surgeon's gloves) being assessed for compliance with established performance standards, there is no "training set" in the context of machine learning or AI models. The gloves are manufactured and then tested to ensure they meet specifications.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as point 8. There is no concept of a "training set" or "ground truth for a training set" for this type of device submission.
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