(65 days)
A device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination and for use handling chemotherapy drugs.
Derma Prene® Powder-Free Synthetic Surgical Gloves (Chemotherapy Use), meet all of the requirements of ASTM D 3577, Type 2.
Derma Prene® Powder-Free Synthetic Surgical Gloves (Chemotherapy Use) meet all the current specifications for ASTM D 3577 Rubber Surgical Gloves.
Derma Prene® Powder-Free Synthetic Surgical Gloves (Chemotherapy Use) are sterile disposable devices intended to be worn by operating room personnel to protect a surgical wound from contamination and for use handling chemotherapy drugs.
Derma Prene® Powder-Free Synthetic Surgical Gloves (Chemotherapy Use) are summarized with the following technological characteristics compared to ASTM or equivalent standards.
Characteristics: Dimensions, Physical Properties, Freedom from holes, Powder-Free, Biocompatability Primary Skin Irritation in Rabbits, Guinea Pig Sensitization
Standard: Meets ASTM D 3577, Meets ASTM D 3577, Type 2, Meets ASTM D 3577, Meets ASTM D 5151, Meets described test in Attachment VI of K980929, Meets ASTM D 6124 Not more than 2 mg residue by mass., Passes, Passes
Here's an analysis of the provided text, focusing on the acceptance criteria and the study used to prove the device meets those criteria:
Device: Derma Prene® Powder-Free Synthetic Surgical Gloves (Chemotherapy Use)
1. Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Dimensions | ASTM D 3577 | Meets ASTM D 3577 |
| Physical Properties | ASTM D 3577, Type 2 | Meets ASTM D 3577, Type 2 |
| Freedom from holes | ASTM D 3577, ASTM D 5151 | Meets ASTM D 3577, ASTM D 5151 |
| Powder-Free | Described test in Attachment VI of K980929 | Not more than 2 mg residue by mass |
| Biocompatibility | Primary Skin Irritation in Rabbits (Passes) | Passes |
| Biocompatibility | Guinea Pig Sensitization (Passes) | Passes |
2. Sample Size and Data Provenance for the Test Set
- Sample Size: The document does not explicitly state the sample size used for the performance tests. It mentions "performance test data of the non clinical tests," but no specific number of units tested.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It implies the studies were conducted by Ansell Perry based on their submission.
3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)
Not applicable. The ground truth for this device (surgical gloves) is established through adherence to recognized international standards (ASTM) and specific performance tests, not through expert consensus on interpretation.
4. Adjudication Method for the Test Set
Not applicable. As the tests involve objective measurements against established standards (e.g., dimensional checks, physical property tests, hole detection), there is no need for an adjudication method by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This type of study is typically used for diagnostic devices where human readers interpret images or data. Surgical gloves are a medical device with objective performance criteria.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a physical product (surgical glove), not an algorithm or AI system. Its performance is measured directly through laboratory testing.
7. Type of Ground Truth Used
The ground truth used is primarily established international standards (ASTM) and objective laboratory test results (e.g., measurements for dimensions, tensile strength, elasticity, freedom from holes, powder residue, and biological response in animal models for biocompatibility).
8. Sample Size for the Training Set
Not applicable. This device is not an AI/ML product; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no AI/ML component, there's no training set or ground truth establishment in this context.
§ 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).