(64 days)
This device is intended to be used as a single use disposable sterile surgical glove.
This Surgeon's Glove is a device made of naturel rubber latex intended to be worn by operating room personnel to protect a surgical wound from contamination.
Classified by FDA's General and Plastic Surgery Device Panel as Class 1, 21 CFR 878.4460, Surgical Powder-free Latex Gloves, 79KGO and meets all requirements of ASTM standard D-3577-91.
The provided documents describe the acceptance criteria and a study to demonstrate the substantial equivalence of Kemwell International Ltd.'s "Coloured Powder-free Latex Surgical Gloves" (later specified as "Green Powder-Free Latex Surgical Gloves") to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (ASTM D 3577-91) | Reported Device Performance |
|---|---|---|
| Physical and Dimensional Testing | Meets ASTM D 3577-91 requirements | Met |
| Pinhole (Water Fill Test) | AQL 1.5 (Inspection Level 1) | Met |
| Primary Skin Irritation | No primary skin irritation reactions | No primary skin irritation reactions |
| Skin Sensitization (Contact Dermatitis) | No sensitization reactions | No sensitization reactions |
2. Sample Size Used for the Test Set and Data Provenance
- Physical and Dimensional Testing: Inspection Level S-2, AQL 2.5. The exact number of gloves sampled is not explicitly stated but is determined by the AQL (Acceptance Quality Limit) and inspection level per ASTM standards.
- Pinhole (Water Fill Test): AQL 1.5, Inspection Level 1. The exact number of gloves sampled is not explicitly stated but is determined by the AQL and inspection level per FDA standards.
- Primary Skin Irritation and Skin Sensitization Testing: The sample size for these biocompatibility tests (e.g., number of test subjects or animals) is not specified in the provided text.
- Data Provenance: The device manufacturer, Kemwell International Ltd., is based in Bangalore, India. The document does not explicitly state the country of origin for the test data, but it is implied to be associated with tests conducted by or for Kemwell. These seem to be prospective tests performed specifically for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is not applicable to this submission. The tests performed are objective, laboratory-based evaluations against established industry standards (ASTM D 3577-91) and regulatory requirements (FDA Water Fill Test, biocompatibility). Expert consensus for "ground truth" as typically seen in AI or diagnostic device studies (e.g., radiologists interpreting images) is not a component of glove testing.
4. Adjudication Method for the Test Set
Not applicable. As the tests are objective measurements against defined acceptance limits, there is no need for an adjudication method by human experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is not relevant for this type of device (surgical gloves). This is a study demonstrating compliance with product standards rather than a comparative effectiveness study involving human readers or interpretation of results.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This submission is for a physical medical device (surgical gloves), not an algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm is not relevant.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to the objective performance specifications defined by:
- ASTM D 3577-91 standards for physical and dimensional properties.
- FDA 1000 ml. Water Fill Test requirements for pinhole integrity.
- Biocompatibility testing standards for primary skin irritation and sensitization.
These standards and requirements serve as the benchmarks against which the device's performance is measured.
8. The Sample Size for the Training Set
Not applicable. This submission is for a physical medical device (surgical gloves). There is no "training set" in the context of machine learning, as this device does not involve an algorithm that learns from data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth established for it.
§ 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).