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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 |
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