(78 days)
This Surgeon's Glove is a device made of natural rubber latex intended to be worn by operating room personnel to protect a surgical wound from contamination. Surface powder should be removed prior to undertaking operative procedures in order to minimise the risk of adverse tissue reaction. Contents sterile until package is opened or damaged.
Class 1, 21 CFR 878.4460. Latex Surgical Gloves, 79 KGO and meets all requirements of ASTM standard D-3577-91.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Latex Surgical Gloves (Pre-Powdered) by FITCO Dipped Products Pvt. Ltd.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ASTM D3577-91 requirements (Physical and Dimensional Testing) | Meets requirements (Inspection Level S-2, AQL 2.5) |
| FDA 1000 ml. Water Fill Test requirements | Meets requirements (Samplings of AQL 1.5, Inspection Level 1) |
| Primary Skin Irritation | No Primary Skin Irritation |
| Skin Sensitization (Allergic Contact Dermatitis) | No Sensitization Reactions |
| FDA's pinhole biocompatibility requirements | Meets requirements |
2. Sample size used for the test set and the data provenance
- Physical and Dimensional Testing (ASTM D3577-91): Inspection Level S-2, AQL 2.5. The exact sample size for this AQL (Acceptable Quality Limit) level is not explicitly stated but is determined by the lot size in accordance with the standard.
- FDA 1000 ml. Water Fill Test: AQL 1.5, Inspection Level 1. Similar to above, the exact sample size is dependent on the lot size.
- Primary skin irritation and Skin sensitization: The sample size for these biological tests is not explicitly stated in the provided text.
- Data Provenance: The tests were conducted internally by FITCO Dipped Products Pvt. Ltd. (stated as a discussion of non-clinical tests performed by the submitter). The country of origin is India. The nature of the tests (physical, dimensional, water fill, biological) implies these were prospective tests conducted on manufactured product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for these types of products (surgical gloves) is established through adherence to standardized test methods (ASTM, FDA water fill test) and biological compatibility tests, rather than expert consensus on specific cases. The "experts" would be the technicians conducting the tests and interpreting the results according to the established standards.
4. Adjudication method for the test set
Not applicable. This type of adjudication (e.g., 2+1, 3+1) is typically used in clinical studies or image-based diagnostic evaluations where individual expert opinions need to be reconciled to establish a ground truth. For product performance standards, passing or failing the defined criteria in the standard is generally clear-cut.
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 device is a medical device (surgical glove), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are irrelevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an algorithm or AI-based device. The "standalone performance" is the performance of the glove itself as demonstrated by the non-clinical tests.
7. The type of ground truth used
The ground truth used is based on:
- Established Industry Standards: ASTM D3577-91 for physical and dimensional characteristics.
- Regulatory Test Methods: FDA 1000 ml. Water Fill Test for barrier integrity (pinholes).
- Biological Testing: Primary skin irritation and skin sensitization tests (implicitly following recognized protocols for such assessments).
8. The sample size for the training set
Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 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).