(164 days)
Surgeon's Glove is a medical device intended to be worn by operating room personnel during surgery to protect a surgical wound from contamination.
Class 1- Surgeon's Gloves (Pre-Powdered) 79KGO that meets all the requirements of ASTM D 3577 - 91. Type 1 - Gloves compounded primarily from Natural Rubber Latex.
The device being described is a Surgeon's Glove manufactured by SRI ANUSHAM RUBBER INDUSTRIES PRIVATE LIMITED. The acceptance criteria and performance data are primarily based on the ASTM D3577-91/95 specifications for latex surgeon's gloves.
Here's the breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance
| Characteristic | Acceptance Criteria (ASTM D3577-95) | Reported Device Performance (SARI Value) | Result |
|---|---|---|---|
| Dimensions | |||
| Length (various sizes) | 245 mm minimum (size 5.5), 265 mm minimum (sizes 6-9) | 270-272mm (all sizes) | Meets |
| Width (various sizes) | Varies by size (e.g., 70 +/- 6 mm for 5.5, 114 +/- 6 mm for 9) | Consistent with ASTM ranges (e.g., 68mm for 5.5, 112mm for 9) | Meets |
| Thickness | 0.1mm minimum at cuff, palm, and finger | 0.12mm (cuff), 0.16mm (palm), 0.19mm (finger) | Meets |
| Physical Properties | |||
| Tensile Strength (Before Ageing) | 24 mpa min. | 31 mpa (SARI Value), 29 mpa (Performance Test Data) | Meets |
| Elongation at Break % (Before Ageing) | 750% min. | 950-975% (SARI Value), 850% (Performance Test Data) | Meets |
| Tensile Strength (After Ageing) | 18 mpa min. | 22 mpa | Meets |
| Elongation at Break % (After Ageing) | 560% min. | 850-900% (SARI Value), 800% (Performance Test Data) | Meets |
| Modulus at 500% Elongation (Before Ageing) | 5.5 mpa (max) | 3.4 mpa | Meets |
| Performance Requirements (AQL) | |||
| Freedom from Holes | AQL 1.5 | AQL 1.5 (SARI) | Meets |
| Dimensions | AQL 4 | AQL 4 (SARI) | Meets |
| Physical Property | AQL 4 | AQL 4 (SARI) | Meets |
| Other Properties | |||
| Powder Content | Not explicitly stated in ASTM, but implied compliance through SARI value. (ASTM D3577-95 typically specifies maximum powder residue) | 120 +/- 20 mg per glove (SARI Value for Powder Content) | Meets |
| Protein Content | FDA Requirement: Value not fixed | 80 +/- 20 ppm | Meets (no fixed requirement) |
| Moisture Content | FDA Requirement: Value not fixed | 0.8% (SARI Value/Maximum for Performance Test Data) | Meets (no fixed requirement) |
| Bio-compatibility | Biologically Compatible (FDA Requirement) | Biologically Compatible | Meets |
| Sterility | NA (as per SARI) | "Fails Sterility" is a defect, not a performance metric for the device itself (AQL level "As per IP" for SARI, "As per USP" for ASTM is listed). The document doesn't explicitly state the glove is sterile, but rather that sterility failure is a defect. | N/A (implied that if claimed sterile it meets standard, but not explicitly stated as a performance criteria metric) |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves for tensile strength testing, number of gloves for hole testing). It refers to "SARI Value" and "Performance Test Data," suggesting internal testing by the manufacturer.
- Data Provenance: The data is retrospective, generated by SRI ANUSHAM RUBBER INDUSTRIES PRIVATE LIMITED, a company located in Nagercoil, Tamil Nadu, S. India. It represents their internal testing results for the purposes of a 510(k) submission to the FDA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. The ground truth is established by adherence to a recognized international standard, ASTM D3577-91/95, which defines the specifications for surgeon's gloves. The "Pioneer Manikandan Buildings" entity appears to be the manufacturer, not an expert panel for ground truth assessment.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. This type of study does not involve human expert adjudication in the traditional sense. The device's performance is objectively measured against a predefined technical standard (ASTM D3577).
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
- MRMC Study: No, a multi-reader multi-case comparative effectiveness study was not done. This is a technical performance study for a physical medical device (surgeon's gloves), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a physical product (surgeon's gloves), not an algorithm or software. Its performance is measured directly through physical and chemical tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: The ground truth is established by existing regulatory standards and technical specifications, specifically the ASTM D3577-91/95 for latex surgeon's gloves. This standard defines the required physical and chemical properties.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. There is no "training set" in the context of this device's evaluation, as it is not a machine learning model. The manufacturer would have internal quality control and manufacturing processes that produce gloves meeting the specifications, but this isn't a "training set" in the AI sense.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable (as per point 8). The manufacturing process and quality control would be geared towards consistent production of gloves that adhere to the ASTM D3577 standards.
§ 878.4460 Non-powdered surgeon's glove.
(a)
Identification. A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls).