(126 days)
A powder free polymer coated latex surgical glove is a disposable device made of natural rubber material intended to be worn by operating room personnel to protect a surgical wound from contamination.
The Powder Free Polymer Coated Latex Surgical Gloves, Sterile, with Protein Labeling claim of 50 micrograms per dm2 of glove or less of water soluble protein will meet all the current specification for ASTM D3577.
Here's a breakdown of the acceptance criteria and study information for the "Powder Free Polymer Coated Latex Surgical Gloves" based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Characteristic | Acceptance Criteria (Standards) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D3577 - 06 | Meets |
| ASTM D 412 - 06ael | Meets | |
| Freedom from pin-holes | ASTM D 5151 - 06 | Meets |
| Powder Free Residue | ASTM D 6124 - 06 | Meets |
| Biocompatibility: Dermal Sensitization | Dermal Sensitization (as per ISO 10993-10) | Not a contact skin sensitizer |
| Biocompatibility: Primary Skin Irritation | Primary Skin Irritation Test (as per ISO 10993-10) | Not a primary skin irritant |
| Protein Labeling Claim | 50 micrograms per dm² of glove or less of water soluble protein | Meets (implied by overall conclusion of safety and effectiveness) |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not provide specific details on the sample size used for the tests to demonstrate compliance with the ASTM and ISO standards. It states that "The performance test data that support a determination of substantial equivalence are described above," referring to the "Device Performance" column in the table.
Regarding data provenance, the document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. The manufacturer is based in Malaysia.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable to this type of device and study. The testing for surgical gloves involves physical and chemical property assessments based on established international standards (ASTM, ISO), not expert interpretation of diagnostic images or patient outcomes.
4. Adjudication Method for the Test Set:
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective interpretation, such as in medical imaging, to resolve discrepancies among experts establishing ground truth. The tests for surgical gloves are objective measurements against defined standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI system on human reader performance, which is not applicable to a physical medical device like surgical gloves.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Yes, a standalone study was done in the sense that the device's performance was evaluated independently against the specified standards without human intervention influencing the device itself. However, this is not an "algorithm-only" study as the device is a physical product, not a software algorithm. The "Device Performance" column reflects the standalone performance of the gloves.
7. The Type of Ground Truth Used:
The ground truth used for this device is based on established objective measurements and performance specifications defined by international standards (ASTM and ISO). For example:
- Dimensions: Measured directly and compared against ASTM D3577.
- Freedom from pin-holes: Evaluated according to ASTM D5151.
- Powder Free Residue: Measured according to ASTM D6124.
- Biocompatibility (Dermal Sensitization, Primary Skin Irritation): Assessed using standardized biological tests as per ISO 10993-10, with defined criteria for "not a contact skin sensitizer" and "not a primary skin irritant."
8. The Sample Size for the Training Set:
This information is not applicable. Surgical gloves are physical devices tested against predefined standards, not machine learning models that require training sets.
9. How the Ground Truth for the Training Set Was Established:
This information is 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).