(114 days)
This device is intended to be used as a single use disposable sterile surgical glove.
Powder-free Latex Surgical Gloves which meets the requirements of ASTM D 3577-91.
This document describes the Glovel Gx Powder-free Latex Surgical Gloves and provides information for its 510(k) submission.
Here's a breakdown of the requested information based on the provided text, focusing on acceptance criteria and the study:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance to ASTM D-3577-91 | Conforms fully to ASTM D-3577-91 standards. All tests meet requirements of Physical and Dimensions Testing. |
| Inspection Level for Physical & Dimensions Testing | S-2 (per ASTM-D-3577-91) |
| AQL for Physical & Dimensions Testing | 2.5 (per ASTM-D-3577-91) |
| FDA 1000 ml Water Fill Test | Met requirements. |
| Inspection Level for Water Fill Test | I |
| AQL for Water Fill Test | 1.5 |
| Primary Skin Irritation | No primary skin irritant reactions. |
| Skin Sensitization (allergic contact dermatitis) | No sensitization reactions. |
| Sterility Assurance Level (SAL) | 10-6 |
| Biocompatibility Requirements | Met (implied by "biocompatibility requirements" conformance in conclusion). |
| Pinhole FDA Requirements | Met. |
| Labeling Claims | Met (implies no special labeling claims, not hypoallergenic). |
| Conformance to 21 CFR references | Conforms fully to applicable 21 CFR references. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "samplings of AQL 1.5, Inspection Level I" for the FDA 1000 ml Water Fill Test and "Inspection Level S-2, AQL 2.5" for Physical and Dimensions Testing. However, specific numerical sample sizes for these tests are not provided.
The data provenance is implied to be from the manufacturer's own testing as part of the 510(k) submission. The submitting company is from India (Kemwell International Ltd., Bangalore, India). The studies appear to be prospective as they are conducted to demonstrate conformance and equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided in the document. The device is a surgical glove, and its performance is assessed against established ASTM standards and FDA tests (e.g., water fill, biocompatibility), not through expert interpretation of data like medical imaging.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. The assessment involves objective measurements against predefined standards and thresholds, not expert adjudication of subjective findings.
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
This information is not applicable and not provided. The device is a surgical glove, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable and not provided. The device is a surgical glove, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device is based on established industry standards (ASTM D-3577-91), regulatory requirements (FDA 1000 ml Water Fill Test, 21 CFR references), and objective laboratory test results (e.g., physical properties, biocompatibility, sterility assurance, skin irritation/sensitization).
8. The sample size for the training set
This information is not applicable and not provided. The concept of a "training set" is relevant for machine learning algorithms, which this device is not. The manufacturing process is designed to meet standards, rather than "trained" on data.
9. How the ground truth for the training set was established
This information is not applicable and not provided for the same reasons as point 8.
§ 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).