(13 days)
Ultralon® Powder Free Latex Surgical Gloves are to be worn by operating room personnel to protect a surgical wound from contamination.
Ultralon® Powder Free Latex Surgical Gloves (Protein Label Claim) meet all the current specifications for ASTM D 3577-00, Rubber Surgical Gloves, Type 1.
This report describes the acceptance criteria and study proving the performance of Ultralon® Powder Free Latex Surgical Gloves (Protein Label Claim).
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Dimensions | Meets ASTM D 3577-00 for Rubber Surgical Gloves, Type 1 | Meets ASTM D 3577-00 |
| Physical Properties | Meets ASTM D 3577-00 for Rubber Surgical Gloves, Type 1 | Meets ASTM D 3577-00 |
| Freedom from Holes | Meets ASTM D 3577-00 for Rubber Surgical Gloves, Type 1 | Meets ASTM D 3577-00 and ASTM D 5151-99 |
| Biocompatibility | Passes Primary Skin Irritation in Rabbits Test | Passes Primary Skin Irritation in Rabbits Test |
| Passes Guinea Pig Sensitization Test | Passes Guinea Pig Sensitization Test | |
| Protein Label Claim | Contains 50 micrograms or less of total water extractable protein per gram | Meets ASTM D 5712-99 Standard Test Method for Analysis of Protein in Natural Rubber and Its Products |
2. Sample Size and Data Provenance for Test Set
The document does not specify a separate "test set" in the context of clinical trials as clinical data were deemed not needed. The product's performance was evaluated against established ASTM standards through non-clinical testing. The sample sizes for these non-clinical tests (e.g., for dimensions, physical properties, freedom from holes, biocompatibility, and protein content) are not explicitly stated in this summary. The data provenance is non-clinical laboratory testing performed by the manufacturer.
3. Number of Experts and Qualifications for Ground Truth for Test Set
Not applicable, as the acceptance criteria are based on established ASTM standards and non-clinical laboratory testing, not on expert consensus from clinicians for a specific test set.
4. Adjudication Method for Test Set
Not applicable. The evaluation was based on meeting pre-defined ASTM standards through laboratory testing.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical data are not needed for medical gloves or for most devices cleared by the 510(k) process."
6. Standalone (Algorithm Only) Performance Study
Not applicable. This device is a physical product (surgical glove), not an algorithm or a device with an AI component requiring standalone algorithm performance evaluation.
7. Type of Ground Truth Used
The "ground truth" for the device's performance relies on:
- Established ASTM Standards: For dimensions, physical properties, freedom from holes (ASTM D 3577-00 and ASTM D 5151-99).
- Established Biocompatibility Tests: Guinea Pig Sensitization and Primary Skin Irritation in Rabbits.
- Established ASTM Standard for Protein Analysis: ASTM D 5712-99 for the protein label claim.
8. Sample Size for Training Set
Not applicable. There is no training set mentioned, as this is a physical medical device evaluated against pre-defined standards, not a machine learning model.
9. How Ground Truth for Training Set Was Established
Not applicable, as there is no training set for this 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).