(206 days)
A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.
These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs:
Chemotherapy Drug Permeation
The following chemicals have been tested with these gloves.
Carmustine (BCNU) 3.3mg/ml 30.4
Cisplatin 1.0mg/ml > 240
Cyclophosphamide (Cytoxan) 20.0mg/ml > 240
Dacarbazine 10.0mg/ml > 240
Doxorubicin Hydrochloride 2.0mg/ml > 240
Etoposide (Toposar) 20.0mg/ml > 240
Fluorouracil 50.0mg/ml > 240
Ifosfamide 50.0mg/ml > 240
Mitoxantrone 2.0mg/ml > 240
Paclitaxel (Taxol) 6.0mg/ml > 240
Thiotepa 10.0mg/ml 59.0
Vincristine Sulfate 1.0mg/ml > 240
CAUTION: Testing showed an average breakthrough time of 30.4 minutes for Carmustine and an average breakthrough time of 59.0 minutes for Thiotepa.
Powder Free Nitrile Surgical Glove, Sterile meets all the requirements of ASTM standard D3577-09, D6978-05 and FDA 21 CFR 878.4460.
The powder free nitrile surgical glove is manufactured from synthetic rubber latex. Inner surface of gloves undergoes surface treatment process to produce a smooth surface that assists the user in donning the gloves with ease without using any lubricant such as powder on the glove surface. The glove is hand specific. The physical properties of glove i.e. tensile strength meet ASTM standard D3577-09.
This document describes the acceptance criteria and performance study for the Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs (K161823).
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance was evaluated against ASTM standards for various characteristics and against the ASTM D6978-05 standard for chemotherapy drug permeation.
| Characteristic | Standard / Acceptance Criteria | Reported Device Performance |
|---|---|---|
| General | ||
| Intended Use | Protection against surgical wound contamination, tested for chemotherapy drugs. | Meets intended use; tested for chemotherapy drugs per ASTM D6978. |
| Material | ASTM D3577-09 (for surgical gloves) | Nitrile (Synthetic Rubber Latex) |
| Color | - | Natural |
| Texture | - | Micro roughened |
| Dimensions | ASTM D3577-09 | Meets |
| Length | ASTM D3577-09: Min 270mm | Min 270mm |
| Width | ASTM D3577-09 | Meets (specific sizes listed: 5 ½ : 70±6mm, 6 : 76±6mm, etc.) |
| Thickness (Finger, Palm, Cuff) | ASTM D3577-09: Min 0.10mm | Meets: Min 0.10mm (for finger, palm, cuff) |
| Physical Properties Before Aging | ASTM D3577-09 | Meets |
| Tensile Strength | 7MPa min | 7MPa min |
| Ultimate Elongation | 650% min | 650% min |
| Stress at 500% Elongation | 7.0MPa min | 7.0MPa min |
| Physical Properties After Aging | ASTM D3577-09 | Meets |
| Tensile Strength | 12MPa min | 12MPa min |
| Ultimate Elongation | 490% min | 490% min |
| Watertight | ASTM D5151-06; 21CFR 800.20 & ASTM D3577 AQL 1.5 | Meets 21 CFR 800.20 and ASTM D3577 when tested in accordance with ASTM D5151 Inspection Level 1, AQL 1.5 |
| Powder Free | ASTM D6124-06 (≤ 2 mg/glove); ASTM D3577 requirements | Meets requirements of ≤2.0 mg/glove for Powder-Free designation per ASTM D3577 |
| Chemotherapy Drug Permeation (ASTM D6978-05) | ||
| Carmustine (BCNU) (3.3mg/ml) | Acceptance criteria not explicitly stated, but compared to predicates. | 30.4 minutes |
| Cisplatin (1.0mg/ml) | Acceptance criteria not explicitly stated, but compared to predicates. | > 240 minutes |
| Cyclophosphamide (Cytoxan) (20.0mg/ml) | Acceptance criteria not explicitly stated, but compared to predicates. | > 240 minutes |
| Dacarbazine (10.0mg/ml) | Acceptance criteria not explicitly stated, but compared to predicates. | > 240 minutes |
| Doxorubicin HCl (2.0mg/ml) | Acceptance criteria not explicitly stated, but compared to predicates. | > 240 minutes |
| Etoposide (Toposar) (20.0mg/ml) | Acceptance criteria not explicitly stated, but compared to predicates. | > 240 minutes |
| Fluorouracil (50.0mg/ml) | Acceptance criteria not explicitly stated, but compared to predicates. | > 240 minutes |
| Ifosfamide (50.0mg/ml) | Acceptance criteria not explicitly stated, but compared to predicates. | > 240 minutes |
| Mitoxantrone (2.0mg/ml) | Acceptance criteria not explicitly stated, but compared to predicates. | > 240 minutes |
| Paclitaxel (Taxol) (6.0mg/ml) | Acceptance criteria not explicitly stated, but compared to predicates. | > 240 minutes |
| Thiotepa (10.0mg/ml) | Acceptance criteria not explicitly stated, but compared to predicates. | 59.0 minutes |
| Vincristine Sulfate (1.0mg/ml) | Acceptance criteria not explicitly stated, but compared to predicates. | > 240 minutes |
| Biocompatibility | ||
| Primary Skin Irritation | ISO 10993-10:2010(E) & Consumer Product Safety Commission, Tittle 16, Chapter II, Part 1500 | Passes; Not a primary skin irritant |
| Dermal Sensitization | ISO 10993-10:2010(E) & Consumer Product Safety Commission, Tittle 16, Chapter II, Part 1500.3(c)(4) | Passes; Not a contact sensitizer |
| Labeling | Medical Glove Guidance Manual - Labeling | Meets (Sizes: 5 ½, 6.0, 6 ½, 7.0, 7 ½, 8.0, 8 ½, 9.0) |
| Single Use | Medical Glove Guidance Manual - Labeling | Single use |
| Sterility Status | Medical Glove Guidance Manual - Labeling | Sterile |
Note regarding Chemotherapy Drug Permeation: For Carmustine and Thiotepa, a "CAUTION" statement is included, indicating average breakthrough times of 30.4 minutes and 59.0 minutes, respectively. This implies that while the glove offers some protection, it is not indefinitely resistant to these specific drugs, and users should be aware of these breakthrough times. The other listed drugs showed breakthrough times greater than 240 minutes, indicating high resistance under the tested conditions.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., number of gloves tested for watertightness, number of samples for chemotherapy permeation). However, it indicates adherence to relevant ASTM standards (D3577-09, D6978-05, D5151-06, D6124-06) and ISO standards (ISO 10993-10), which would dictate appropriate sample sizes for these types of tests.
The data provenance is not explicitly stated in terms of country of origin for the testing, but the submitter is WRP Asia Pacific Sdn Bhd, located in Malaysia. The testing adheres to international and US standards (ASTM, ISO, 21 CFR), suggesting a globally recognized testing methodology. The studies are non-clinical performance tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the ground truth for medical gloves is established through objective physical, chemical, and biological testing against established international and national standards (ASTM, ISO, FDA regulations). There is no mention of human expert assessment or consensus being used to establish a "ground truth" for the device's performance characteristics in the way it might be for diagnostic AI.
4. Adjudication Method for the Test Set
This is not applicable as the evaluation relies on objective measurements and compliance with predefined standards, not on human interpretation or adjudication of subjective data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
This is not applicable. An MRMC study is relevant for evaluating the impact of an AI system on human reader performance, typically in diagnostic imaging. This document describes the testing of a medical device (surgical glove) based on its physical properties and resistance to chemicals, which does not involve human readers interpreting data alongside an AI.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
This is not applicable. The device is a physical product (surgical glove), not an AI algorithm. Its performance is measured directly through laboratory tests.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- Performance against established standards: This includes physical property measurements (tensile strength, elongation, dimensions), impermeability (watertightness), chemical resistance (chemotherapy drug permeation), cleanliness (powder-free), and biocompatibility (skin irritation, sensitization) as defined by ASTM and ISO standards and FDA regulations.
- The metrics are objective and quantitatively measured (e.g., length in mm, breakthrough time in minutes, mg/glove for powder, MPa for tensile strength).
8. The Sample Size for the Training Set
This is not applicable. The device is a physical product, not an AI model. Therefore, there is no "training set" in the context of machine learning. The manufacturing process is likely subject to quality control and statistical process control, which involves ongoing testing and process adjustments, but this is distinct from an AI training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reason stated in point 8.
§ 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).