(390 days)
Biogel® Skinsense® Surgical Gloves are intended to be worn on the hands, usually in surgical settings, to provide barrier against potentially infectious material, and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Biogel® PI UltraTouch™ G Surgical Gloves are intended to be worn on the hands, usually in surgical settings, to provide barrier against potentially infectious material, and other contaminants. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
The subject devices are disposable powder-free surgical gloves that are supplied sterile and are not made from natural rubber latex. They have been tested for use with chemotherapy agents. The Biogel® PI UltraTouch™ G surgical gloves are made from synthetic polyisoprene material and the Biogel® SkinSense® surgical gloves are made from synthetic polychloroprene material. The gloves have been previously 510(k) cleared through K050184 and K053102 respectively.
Here's a breakdown of the acceptance criteria and study information for the Biogel® PI UltraTouch™ G Surgical Glove and Biogel® SkinSense® Surgical Glove, based on the provided document:
This document is a 510(k) Pre-Market Notification, specifically addressing the addition of an "intended use claim" for "Tested for use with Chemotherapy Drugs" to existing surgical gloves. Therefore, the "device" in question refers to the performance of these gloves when exposed to chemotherapy agents.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the testing standard ASTM D6978, which is "Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs". The reported device performance is the "Breakthrough Detection Time" for various chemotherapy drugs. A longer breakthrough time indicates better protection. The document primarily compares the subject devices to predicate devices.
| Drug and Concentration | Acceptance Criteria (Implied: longer time is better, generally >240 minutes is considered excellent) | Biogel® PI UltraTouch™ G (Breakthrough Detection Time in Minutes) | Biogel® SkinSense® (Breakthrough Detection Time in Minutes) |
|---|---|---|---|
| Bleomycin 15 mg/ml | N/A (Standard based on predicate comparison) | >240 | >240 |
| Busulfan 6 mg/ml | N/A | >240 | >240 |
| Carmustine 3.3 mg/ml | N/A (Note: Predicates show very low times) | 12.1 | 60.2 |
| Cisplatin 1.0 mg/ml | N/A | >240 | >240 |
| Cyclophosphamide 20 mg/ml | N/A | >240 | >240 |
| Cytarabine 100 mg/ml | N/A | >240 | >240 |
| Dacarbazine 10 mg/ml | N/A | >240 | >240 |
| Doxorubicin Hydrochloride 2 mg/ml | N/A | >240 | >240 |
| Ellence 2 mg/ml | N/A | >240 | Unavailable (not tested / value not provided) |
| Etoposide 20 mg/ml | N/A | >240 | >240 |
| Fludarabine 25 mg/ml | N/A | >240 | >240 |
| Fluorouracil 50 mg/ml | N/A | >240 | >240 |
| Idarubicin 1 mg/ml | N/A | >240 | >240 |
| Ifosfamide 50 mg/ml | N/A | >240 | >240 |
| Mechlorethamine HCl 1 mg/ml | N/A | >240 | >240 |
| Melphalan 5 mg/ml | N/A | >240 | >240 |
| Methotrexate 25 mg/ml | N/A | >240 | >240 |
| Mitomycin C 0.5 mg/ml | N/A | >240 | >240 |
| Mitoxantrone 2 mg/ml | N/A | >240 | >240 |
| Paclitaxel 6 mg/ml | N/A | >240 | >240 |
| Paraplatin 10 mg/ml | N/A | >240 | >240 |
| Rituximab 10 mg/ml | N/A | >240 | >240 |
| Thiotepa 10 mg/ml | N/A (Note: Predicates show very low times) | 15.5 | 75.8 |
| Trisenox 0.1 mg/ml | N/A | >240 | Not tested |
| Vincristine Sulfate 1 mg/ml | N/A | >240 | >240 |
Note on Acceptance Criteria: The document does not explicitly state numerical acceptance criteria for breakthrough times (e.g., "must be greater than X minutes"). Instead, the performance is presented to demonstrate substantial equivalence to predicate devices, which are also marketed for chemotherapy drug protection. The implied acceptance is that the subject devices perform at least as well as, or better than, the predicate devices, particularly for comparable "Breakthrough Detection Times." The "Summary of features and technological characteristics" table (pages 9-10) states that the intended use is supported by these permeation breakthrough times and "Comparisons are made between the subject devices and predicate devices that are currently 510(k) cleared and marketed for this specific use."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact number of gloves or replicates tested for each chemotherapy agent. It only states that "Permeation testing was conducted... according to ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs."
- Data Provenance: Not specified, but generally, such testing for FDA submissions is performed by accredited laboratories. The document does not indicate the country of origin of the data or whether it was retrospective or prospective, as this type of in-vitro testing is typically performed prospectively in a lab setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This is not applicable to this study. The "ground truth" for this device is established through an objective, standardized chemical permeation test (ASTM D6978), not through human expert assessment or clinical judgment. The "truth" is the measured breakthrough time of the chemical through the glove material.
4. Adjudication Method for the Test Set
Not applicable. There is no human adjudication for chemical permeation testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC study was not done. This study is an in-vitro chemical permeation test of gloves, not an AI or human reader performance study.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable to the device being described. The device is a surgical glove, and the study evaluates its physical/chemical barrier properties, not an algorithm's performance.
7. The Type of Ground Truth Used
The "ground truth" for this study is the measured chemical permeation breakthrough time according to the standardized test method ASTM D6978. This is a form of objective, quantitative laboratory measurement rather than expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is not a machine learning or AI device. The testing conducted is for physical and chemical properties of a product.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set.
§ 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).