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510(k) Data Aggregation
(128 days)
The glove is intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978.
Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs is a disposable single-use, sterile, natural-colored and powder-free surgical glove made from rubber latex. They are in different sizes - 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0. Gloves meet the specification of ASTM D3577-19 and have been tested for resistance to permeation by chemotherapy drugs as per ASTM D6978-05(2019).
The provided text describes the acceptance criteria and the study that proves a medical device (Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs) meets those criteria.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance is primarily assessed against ASTM standards and biocompatibility tests. The table below summarizes these, focusing on the key performance characteristics relevant to general surgical gloves and their resistance to chemotherapy drugs.
| Acceptance Criteria / Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physical Properties (per ASTM D3577-19) | ||
| Length (size 5.5) | ≥ 245 mm | 283-308 mm |
| Length (size 6-9) | ≥ 265 mm | 283-308 mm |
| Palm Width (e.g., size 5.5, 6.0, etc.) | Specific ranges (e.g., 5.5: 70±6 mm, 6.0: 76±6 mm, etc.) | Average values within specified ranges (e.g., 5.5: 72 mm, 6.0: 76 mm) |
| Finger Thickness | Minimum 0.10 mm | 0.20-0.26 mm |
| Palm Thickness | Minimum 0.10 mm | 0.19-0.24 mm |
| Cuff Thickness | Minimum 0.10 mm | 0.16-0.19 mm |
| Tensile Strength, Before Aging | ≥ 24 MPa | Average 24-29 MPa |
| Ultimate Elongation, Before Aging | ≥ 750 % | Average 750-851% |
| Stress at 500% Elongation | ≤ 5.5 MPa | Average 2.1-4.5 MPa |
| Tensile Strength, After Accelerated Aging | ≥ 18 MPa | Average 18-25 MPa |
| Ultimate Elongation, After Accelerated Aging | ≥ 560 % | Average 610-796 % |
| Other Performance Metrics | ||
| Freedom from holes (per ASTM D3577-19, ASTM D 5151-19) | AQL 1.5 requirements | Meets AQL 1.5 |
| Powder-Free (per ASTM D3577-19, ASTM D6124-06 (2022)) | ≤ 2 mg per glove | 0.09-0.12 mg per glove |
| Aqueous Extractable Protein Content (per ASTM D3577-19, ASTM D5712-15) | ≤ 200 ug/dm² | 0.07-0.34 ug/dm² |
| Sterility Assurance Level | 10-6 SAL | 10-6 SAL |
| Chemotherapy Drug Permeation (per ASTM D6978-05 (2019)) | ||
| Bleomycin Sulfate 15mg/ml (15000 ppm) | Minimum Breakthrough Detection Time (BDT) based on predicate/reference devices (typically >240 minutes for most drugs, except Carmustine and Thiotepa) | >240 minutes |
| Busulfan 6mg/ml (6,000 ppm) | - | >240 minutes |
| Carboplatin 10mg/ml (10,000 ppm) | - | >240 minutes |
| Carmustine (BCNU)3.3 mg/ml (3,300 ppm) | Comparative to predicate/reference (e.g., predicate 13.2 min, reference 12.6 min) | 14.0 minutes (Note: Warning: Do not use with Carmustine) |
| Cisplatin 1mg/ml (1,000 ppm) | - | >240 minutes |
| Cyclophosphamide 20mg/ml (20,000 ppm) | - | >240 minutes |
| Cytarabine HCL, 100 mg/ml (100,000 ppm) | - | >240 minutes |
| Dacarbazine 10 mg/ml (10,000 ppm) | - | >240 minutes |
| Doxorubicin HCL, 2 mg/ml (2,000 ppm) | - | >240 minutes |
| Etoposide, 20 mg/ml (20,000 ppm) | - | >240 minutes |
| Epirubicin HCL, 2 mg/ml (2,000 ppm) | - | >240 minutes |
| Fludarabine, 25 mg/ml (25,000 ppm) | - | >240 minutes |
| Fluorouracil, 50mg/ml (50,000ppm) | - | >240 minutes |
| Idarubicin HCL, 1mg/ml (1,000ppm) | - | >240 minutes |
| Ifosfamide, 50mg/ml (50,000ppm) | - | >240 minutes |
| Mechlorethamine HCI, 1mg/ml (1,000ppm) | - | >240 minutes |
| Melphalan, 5mg/ml (5,000ppm) | - | >240 minutes |
| Methotrexate, 25mg/ml (25,000ppm) | - | >240 minutes |
| Mitomycin C, 0.5mg/ml (500ppm) | - | >240 minutes |
| Mitoxantrone HCL, 2mg/ml (2,000ppm) | - | >240 minutes |
| Paclitaxel, 6mg/ml (6,000ppm) | - | >240 minutes |
| Paraplatin, 10mg/ml (10,000ppm) | - | >240 minutes |
| Rituximab, 10mg/ml (10,000ppm) | - | >240 minutes |
| Thio Tepa, 10mg/ml (10,000ppm) | Comparative to predicate/reference (e.g., predicate 12.0 min, reference 22.4 min) | 16.1 minutes (Note: Warning: Do not use with Thiotepa) |
| Vincristine Sulfate, 1mg/ml (1,000ppm) | - | >240 minutes |
| Biocompatibility (per ISO 10993 series) | ||
| Skin Sensitization (ISO 10993-10) | No significant evidence of causing skin sensitization | No significant evidence of causing skin sensitization |
| Intracutaneous Reactivity (ISO 10993-23) | Polar and non-polar extract score less 1.0 | Test met requirements (score less 1.0) |
| Cytotoxicity (ISO 10993-5) | Acceptable level of cytotoxicity (comparison to predicate for "grade 2 at 1:16 dilution, grade 0 at 1:32 and 1:64 dilutions") | Showed potential toxicity to L929 cells (Note: This is presented as meeting the acceptance criteria by the submitter, implying it's acceptable for the device type) |
| Acute Systemic Toxicity (ISO 10993-11) | No evidence of acute systemic toxicity | No evidence of acute systemic toxicity |
| Material-mediated Pyrogenicity (ISO 10993-11) | No rabbit shows an individual rise in temperature of 0.5°C or more | Test met requirements (no rabbit showed individual rise in temperature of 0.5°C or more) |
| Endotoxin | <20 EU/glove | <20 EU/glove |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the specific sample sizes for each individual test. However, it indicates that "Non-clinical testing was performed to verify that the subject device meets the acceptance criteria of the performance test and all design specifications." The testing was conducted in accordance with recognized international and national standards (ASTM, ISO, U.S. Pharmacopeia).
- Sample Size: Not explicitly stated for each test, but implied to be sufficient to meet the statistical requirements of the listed ASTM and ISO standards for each test (e.g., AQL 1.5 for freedom from holes implies a certain sample size for inspection).
- Data Provenance: The manufacturer is "Grand Work Plastic Products Co., Ltd." in "Zanhuang, Hebei, 050000 China." The tests would have been performed by or for this company. The document does not specify if the testing was performed in China or by an external laboratory.
- Retrospective or Prospective: The testing described is prospective, as it involves evaluating a new device against predefined standards to support its market clearance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This type of information (number and qualifications of experts) is generally relevant for studies involving subjective interpretation, especially in AI/imaging devices. For the physical and chemical testing of surgical gloves, "ground truth" is established by adherence to standardized test methods (e.g., ASTM D3577 for physical properties, ASTM D6978 for chemotherapy permeation, ISO 10993 for biocompatibility). The "experts" in this context would be the technicians and scientists performing and interpreting these standardized tests in a laboratory setting, who are qualified to execute these specific methodologies. Their specific number or individual qualifications are not detailed in this type of regulatory submission but are assumed to meet the requirements of the testing laboratories.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or expert review processes where there is subjective interpretation involved, especially for ground truth establishment in medical imaging or diagnostic devices. For the non-clinical physical, chemical, and biocompatibility testing of surgical gloves, such adjudication methods are not applicable. The results are obtained through objective measurements and standardized protocols with predetermined pass/fail criteria.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. An MRMC comparative effectiveness study is not relevant for this device. This is a physical medical device (surgical glove), not an AI-powered diagnostic or assistive technology that involves human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This concept is not applicable to a physical surgical glove. "Standalone" performance testing for this device refers to its physical and chemical properties and its barrier properties, measured objectively according to specified standards, without any "human-in-the-loop" component in its performance itself (though human labor is involved in its use).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on established industry standards and objective physical/chemical measurements. Specifically:
- ASTM D3577-19: Standard Specification for Rubber Surgical Gloves (defines dimensions, physical properties, freedom from holes).
- ASTM D5151-19: Standard Test Method for Detection of Holes in Medical Gloves.
- ASTM D6124-06 (2022): Standard Test Method for Residual Powder on Medical Gloves.
- ASTM D6978-05 (2019): Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs (defines the permeation testing methodology).
- ASTM D5712-15 (2020): Standard Test Method for the Analysis of Aqueous Extractable Protein in Natural Rubber and Its Products Using the Modified Lowry Method.
- ISO 10993 series: Biological evaluation of medical devices (for biocompatibility tests like cytotoxicity, sensitization, systemic toxicity, pyrogenicity).
- U.S. Pharmacopeia: Sterility Test.
The pass/fail criteria and metric values within these standards serve as the "ground truth."
8. The sample size for the training set
This is not applicable. The device is a physical product (surgical glove), not a software algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for this type of device.
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