(48 days)
Surgeon's glove is a medical device intended to be worn by operating room personnel to protect a surgical wound from contamination.
Class I Surgeon's Glove 79KGO powdered with Absorbable Dusting Powder that meets all 'the requirements of ASTM D3577.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:
Device: Surgeon's Glove (Latex, Powdered with Absorbable Dusting Powder) manufactured by Shiva Medicare Limited.
1. Table of Acceptance Criteria and Reported Device Performance:
The document presents two main sets of criteria: Technological Characteristics and Performance Requirements.
| Characteristic / Requirement | Acceptance Criteria (ASTM D3577 / FDA) | Reported Device Performance (SML Value) | Compliance | Notes |
|---|---|---|---|---|
| 1. Length | 245 mm minimum (size 5 ½) | 270-272 mm | Meets | For all sizes (5 ½ to 9), SML values are 270-272 mm, exceeding the minimums (245 mm for 5 ½, 265 mm for others). |
| 265 mm minimum (sizes 6-9) | Meets | |||
| 2. Width | Meets | For all sizes, SML values fall within the +/- 6 mm tolerance for the ASTM D3577 requirement. | ||
| Size 5 ½ | 70 +/- 6 mm | 68 mm | Meets | |
| Size 6 | 76 +/- 6 mm | 73 mm | Meets | |
| Size 6 ½ | 83 +/- 6 mm | 79 mm | Meets | |
| Size 7 | 89 +/- 6mm | 87 mm | Meets | Note: ASTM D3577 listed as 99 +/- 6mm for size 7 in one table, but 89 +/- 6mm is expected based on progression. Assuming 89 +/- 6mm as intended for typical sizing. |
| Size 7 ½ | 95 +/- 6mm | 92 mm | Meets | |
| Size 8 | 105 +/- 6mm | 103 mm | Meets | |
| Size 8 ½ | 108 +/- 6mm | 106 mm | Meets | |
| Size 9 | 114 +/- 6mm | 112 mm | Meets | |
| 3. Thickness | 0.1 mm (at cuff, palm, fingertip) | 0.12, 0.16, 0.19 mm (at cuff, palm, fingertip) | Meets | All reported values are greater than the 0.1 mm minimum. |
| 4. Physical Properties - Before Ageing | ||||
| Tensile Strength | 24 mpa (min) | 27 mpa | Meets | Exceeds minimum. |
| Elongation at Break % | 750% (min) | 850% | Meets | Exceeds minimum. |
| Modulus at 500 % Elongation | 5.5 mpa (max) | 3 mpa | Meets | Below maximum. |
| 5. Physical Properties - After Ageing | ||||
| Tensile Strength | 18 mpa (min) | 20 mpa | Meets | Exceeds minimum. |
| Elongation at Break % | 560% (min) | 750% | Meets | Exceeds minimum. |
| 6. Sterility | As per USP | As per IP (Indian Pharmacopea) | Meets | Implied equivalence or acceptance of IP standards. |
| 7. Freedom from Holes | AQL 1.5 | AQL 1.5 | Meets | Both SML and ASTM D3577 require AQL 1.5 with Level S4. |
| 8. Dimensional | AQL 4 | AQL 4 | Meets | Both SML and ASTM D3577 require AQL 4 with Level S2 for SML and S4 for ASTM. SML's S2 is also an acceptable level. |
| 9. Physical Property | AQL 4 | AQL 4 | Meets | Both SML and ASTM D3577 require AQL 4 with Level S2. |
| 10. Powder Content | No clear ASTM requirement in table | 120 +/- 20 mg | N/A | SML reports its value. ASTM D3577 table not legible. |
| 11. Protein Content | Value not fixed (FDA Requirement) | 80 +/- 20 ppm | Meets | SML reports its value, which implicitly meets "not fixed" if disclosed. |
| 12. Moisture Content | No value fixed (FDA Requirement) | 0.8% max | Meets | SML reports its value, which implicitly meets "not fixed" if disclosed. |
| 13. Biocompatibility | Biologically Compatible (FDA Req.) | Biologically Compatible | Meets | Direct match. |
Conclusion of Performance Test Data: The document explicitly states:
- "The Surgeon's gloves manufactured by Shiva Medicare Limited"
- "Meet or exceed the ASTM D3577"
- "Meet FDA Pin hole Requirement."
- "Meet labelling claim as shown by the data in 6 -" (presumably referring to section 6.0, intended use).
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample sizes used for each test (length, width, tensile strength, etc.). It provides 'values' for characteristics and 'levels followed' (e.g., S4, S2) for performance requirements, which are typically associated with sampling plans (e.g., ISO 2859). However, the exact number of units tested for any given parameter is not provided.
The data provenance is retrospective, as it refers to performance data obtained from manufacturing processes already completed by Shiva Medicare Limited. The origin of the data is India (Chennai, specifically, where Shiva Medicare Limited is located).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
Not applicable. This device is a medical glove, not a diagnostic or AI-driven device requiring expert adjudication for ground truth. The "ground truth" here is defined by the objective physical and chemical properties and performance standards outlined in ASTM D3577 and FDA requirements.
4. Adjudication Method for the Test Set:
Not applicable. As noted above, this is not an AI or diagnostic study requiring expert adjudication. The assessment is based on direct measurement and comparison to established standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (e.g., medical imaging AI) where human readers interpret cases, and the AI's impact on their performance is measured. This document pertains to a physical medical device (surgical gloves).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
Not applicable. There is no algorithm or AI component in this device.
7. The Type of Ground Truth Used:
The ground truth used is based on International Standards and Regulatory Requirements. Specifically:
- ASTM D3577: Standard specification for rubber surgical gloves. This provides the objective, measurable criteria for physical dimensions and mechanical properties.
- USP (United States Pharmacopeia) / IP (Indian Pharmacopeia): For sterility requirements.
- FDA Requirements: For aspects like pinhole (freedom from holes), protein content, moisture content, and biocompatibility.
8. The Sample Size for the Training Set:
Not applicable. There is no AI model, and thus no "training set" for this device. The data presented are from product testing and quality control processes.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set. The "ground truth" for the device's acceptable performance is established by consensus standards organizations (like ASTM) and regulatory bodies (like FDA), which define the required physical, chemical, and performance attributes for the product.
§ 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).