(103 days)
Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs is intended to be worn by operating room personnel to protect surgical wound from contamination. It is also tested for use against Chemotherapy Drugs.
The gloves were tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs.
| Chemotherapy Drug and Concentration | Minimum Breakthrough Detection Time in Minutes |
|---|---|
| Carmustine (3.3 mg/ml) | 12.3 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (20.0 mg/ml) | >240 |
| Dacarbazine (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Paclitaxel (6.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 17.4 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Please note that Carmustine and Thiotepa have extremely low permeation times of 12.3 minutes and 17.4 minutes respectively.
Warning: Do not use with Carmustine and Thiotepa
Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs is a disposable single-use, sterile, natural-colored and powder-free surgical glove made from synthetic polyisoprene latex.
The provided documents describe the acceptance criteria and performance of the Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs. This is a medical device, and the information is presented as part of an FDA 510(k) premarket notification.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The core of the acceptance criteria and device performance is detailed in the "TECHNOLOGICAL CHARACTERISTICS COMPARISON TABLE" and the "SUMMARY OF NON-CLINICAL TESTING" sections.
| Characteristic / Test Methodology | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Chemotherapy Drugs Permeation | ASTM D6978-05 (Reapproved 2019): Under the conditions of the study, no permeation. | Carmustine (3.3 mg/ml): 12.3 minutes |
| Cisplatin (1.0 mg/ml): > 240 minutes | ||
| Cyclophosphamide (20.0 mg/ml): > 240 minutes | ||
| Dacarbazine (10.0 mg/ml): > 240 minutes | ||
| Doxorubicin Hydrochloride (2.0 mg/ml): > 240 minutes | ||
| Etoposide (20.0 mg/ml): > 240 minutes | ||
| Fluorouracil (50.0 mg/ml): > 240 minutes | ||
| Methotrexate (25.0 mg/ml): > 240 minutes | ||
| Mitomycin C (0.5 mg/ml): > 240 minutes | ||
| Paclitaxel (6.0 mg/ml): > 240 minutes | ||
| Thiotepa (10.0 mg/ml): 17.4 minutes | ||
| Vincristine Sulfate (1.0 mg/ml): > 240 minutes | ||
| Note: Carmustine and Thiotepa had extremely low permeation times, leading to a "Do not use" warning. | ||
| Freedom from Holes | ASTM D3577-19 requirements of AQL 1.5 | Meets ASTM D3577-19 requirements of AQL 1.5 |
| Length (ASTM D3577-19) | Varies by size (e.g., 5.5: Min 245mm, 6.0-9.0: Min 265mm) | Meets ASTM D3577-19 requirements for length (e.g., Size 5.5: 285mm, Size 9.0: 291mm) |
| Width (ASTM D3577-19) | Varies by size (e.g., 5.5: 70 ± 6mm, 9.0: 114 ± 6mm) | Meets ASTM D3577-19 requirements for width (e.g., Size 5.5: 74mm, Size 9.0: 116mm) |
| Thickness (ASTM D3577-19) | Palm, Finger, Cuff Minimum 0.10 mm | Meets ASTM D3577-19 requirements for thickness (e.g., Palm: 0.19-0.21mm, Finger: 0.23-0.24mm, Cuff: 0.15-0.16mm) |
| Tensile Strength (ASTM D3577-19) | Before Aging: ≥ 17 MPa | |
| After Aging: ≥ 12 MPa | Before Aging: Average 17.9 MPa | |
| After Aging: Average 15.2 MPa | ||
| Ultimate Elongation (ASTM D3577-19) | Before Aging: ≥ 650 % | |
| After Aging: ≥ 490 % | Before Aging: Average 952 % | |
| After Aging: Average 940 % | ||
| Stress at 500% Elongation (ASTM D3577-19) | Max 7.0 MPa (Before Aging) | Average 2.2 MPa (Before Aging) |
| Powder Residual (ASTM D6124-06 (2017)) | ≤ 2 mg per glove | Average 0.34 mg/glove |
| In Vitro Cytotoxicity (ISO 10993-5) | Not cytotoxic | Found to be cytotoxic, but further evaluation (ISO 10993-11) showed no systemic toxicity. |
| Primary Skin Irritation (ISO 10993-10) | Not an irritant | Not an irritant |
| Dermal Sensitization (ISO 10993-10) | Not a sensitizer | Not a sensitizer |
| Acute Systemic Toxicity (ISO 10993-11) | Does not pose a toxicity concern | No signs of toxicity |
| Pyrogenicity Test (USP ) | Non-pyrogenic | Non-pyrogenic |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for each test in the "test set" (i.e., the data used to prove the device meets acceptance criteria). However, it lists recognized industry standards (ASTM, ISO, USP) for each test. These standards typically define minimum sample sizes for testing to ensure statistical validity.
The data provenance can be inferred based on the applicant information:
- Country of Origin of the Data: The applicant is Hartalega NGC Sdn. Bhd., located in Sepang, Selangor, Malaysia. Therefore, the testing was likely conducted in Malaysia or by laboratories commissioned by the Malaysian company.
- Retrospective or Prospective: These are non-clinical (laboratory) tests performed on the device to demonstrate its properties. This would be considered prospective in the sense that the tests were specifically conducted to evaluate this new device for regulatory submission, not retrospectively analyzed from existing data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable as the evaluation relies on objective, standardized laboratory tests (e.g., chemical permeation, physical property measurements, biocompatibility assays) rather than expert interpretation of a "test set" in the context of medical imaging or diagnostic algorithms. The "ground truth" is established by the defined parameters and methodologies of the ASTM, ISO, and USP standards.
4. Adjudication Method for the Test Set
This is not applicable as the evaluation relies on objective, standardized laboratory tests. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human readers and subjective interpretations, such as radiology image reviews.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "CLINICAL PERFORMANCE DATA: Not applicable. There was no clinical data required to support the subject device as the indication for use is equivalent to the predicate device." MRMC studies are used to evaluate the diagnostic performance of devices, often medical imaging AI, with human-in-the-loop scenarios. This document describes the performance of a physical medical device (surgical glove) through non-clinical testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical surgical glove, not an algorithm or AI system. The tests evaluate the physical and chemical properties of the glove itself.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is based on established standard test methodologies and defined acceptance criteria set by organizations like ASTM, ISO, and USP. These are objective measurements:
- Physical measurements (length, width, thickness)
- Mechanical properties (tensile strength, elongation)
- Chemical resistance (breakthrough time for chemotherapy drugs)
- Biological safety (cytotoxicity, irritation, sensitization, systemic toxicity, pyrogenicity)
It does not involve expert consensus, pathology, or outcomes data in the typical sense of AI/diagnostic device evaluation.
8. The Sample Size for the Training Set
This is not applicable. This is a physical medical device, not an AI or machine learning model that requires a training set. The term "training set" refers to data used to train an algorithm.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the same reason as Section 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).