(119 days)
MEDISPO powdered surgeon's gloves are sterile disposable devices made of natural rubber latex that bears powder to facilitate donning, and it is intended to be worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
MEDISPO-PF powder-free surgeon's gloves are sterile disposable devices made of natural rubber latex (that may bear a trace amount of glove powder) and is intended to he worn on the hands, usually in surgical settings, to provide a barrier against potentially infectious materials and other contaminants.
MEDISPO and MEDISPO-PF meet the requirements for surgical gloves described by ASTM D3577.
Acceptance Criteria and Device Performance Study for H.B.M. USA Co., Inc. – Latex Sterile Surgical Gloves
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical Properties | |
| Meets requirements for surgical gloves described by ASTM D3577 | Tests conducted per ASTM D3577 indicate the product meets the requirements. |
| Biocompatibility | |
| No sensitization | Tests indicate no sensitization. |
| No irritation | Tests indicate no irritation. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Tests conducted per ASTM D3577." ASTM D3577 itself outlines standard test methods and specifications for rubber surgical gloves, which would implicitly define sample sizes for specific tests (e.g., tensile strength, elongation, barrier integrity).
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. For medical devices like surgical gloves, "ground truth" is typically established through adherence to recognized international standards (like ASTM D3577), which specify objective laboratory testing methods rather than requiring expert consensus on subjective observations.
4. Adjudication Method for the Test Set
Not applicable. The evaluation of surgical gloves against ASTM D3577 involves objective laboratory measurements and tests, not subjective interpretations requiring an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This type of study is relevant for diagnostic imaging or screening devices where human readers interpret complex data. Surgical gloves are evaluated based on their physical and biocompatibility properties, not on reader performance.
6. Standalone (Algorithm Only) Performance
Not applicable. Surgical gloves are not an AI-driven device or an algorithm. Their performance is assessed through physical and chemical testing.
7. Type of Ground Truth Used
The "ground truth" for the device's performance is established by adherence to the specifications and test methods outlined in the ASTM D3577 standard. This includes objective measurements of properties like dimensions, physical integrity (e.g., absence of holes), tensile strength, and elongation, as well as biocompatibility tests for irritation and sensitization.
8. Sample Size for the Training Set
Not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set, this question is not relevant.
§ 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).