(225 days)
These surgical gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves were tested for use with chemotherapy drugs, have low dermatitis potential, and are nonpyrogenic. 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.
Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential are sterile and disposable devices. Gloves are made of synthetic polyisoprene rubber, are white in color, and are available in sizes 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, and 9.0. A polyurethane polymer coating is applied to the inner surface of the glove to make donning easy.
This document is a 510(k) premarket notification for a medical device: "Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential" (K230079). It compares the new device to a predicate device (K190018) and provides evidence of performance through various tests.
Here's an analysis of the acceptance criteria and supporting studies based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document presents a comparison of the subject device (K230079) against a predicate device (K190018) and also summarizes non-clinical testing. Below is a compilation of the acceptance criteria (standards/guidance/test criteria) and the reported device performance.
| Test/Characteristic | Acceptance Criteria (Standard/Guidance/Criteria) | Reported Device Performance (K230079) |
|---|---|---|
| Chemotherapy Permeation | ASTM D6978-05 (2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs | All drugs with BDT >240 minutes met criteria.Carmustine (BCNU) (3.3 mg/ml): 12.6 minutesThiotepa (10.0 mg/ml): 26.6 minutes (Note: For marketing, the device labels a warning against using with Carmustine and Thiotepa due to "extremely low permeation times".) |
| Dimensions (Length) | ASTM D3577 requirements: Minimum 265mm | Pass |
| Dimensions (Palm Width) | ASTM D3577 requirements (specific to each size 5.5-9.0, e.g., 5.5: 70±6mm, 9.0: 114±6mm) | Pass for all sizes |
| Dimensions (Thickness - Finger) | ASTM D3577 requirements: Minimum 0.10mm | Pass |
| Dimensions (Thickness - Palm) | ASTM D3577 requirements: Minimum 0.10mm | Pass |
| Dimensions (Thickness - Cuff) | ASTM D3577 requirements: Minimum 0.10mm | Pass |
| Physical Properties | ASTM D3577-19 requirements for tensile strength, ultimate elongation, and stress at 500% elongation before and after accelerated aging for synthetic surgical gloves | Pass |
| Freedom from holes | ASTM D3577-19 and ASTM D5151-06 requirements; AQL 1.5 | Pass |
| Powder-Free | ASTM D3577-19, ASTM D6124-06 requirements: ≤ 2 mg per glove | Pass |
| Sterility | ANSI/AAMI/ISO 11137-1:2018 requirement of 10^-6 SAL | Pass |
| ISO In Vitro Cytotoxicity | ISO 10993-5:2009: Non-cytotoxic (as the general acceptance criteria) | Under the conditions of the study, the device was found to be cytotoxic. However, "the device extracts did not elicit acute systemic response in the animal model" in the follow-up Acute Systemic Toxicity test (ISO 10993-11). This is a notable finding, indicating the device failed the initial cytotoxicity but was deemed safe due to subsequent testing. |
| ISO Skin Irritation Study | ISO 10993-10:2010: Not an irritant | Pass |
| ISO Maximization Sensitization Study | ISO 10993-10:2010: Not a sensitizer | Pass |
| ISO Acute Systemic Toxicity Study | ISO 10993-11:2006: No mortality or evidence of acute systemic toxicity | Pass (addressed after initial cytotoxicity finding) |
| Human Skin Sensitization | Modified Draize-95 Test (per FDA guidance): Not a sensitizer (demonstrates low dermatitis potential) | Pass: "The results showed low dermatitis potential for the human subject tested." |
| Endotoxin Study | Less than 20.0 EU/device | Pass: "test results indicate low endotoxin level" |
| Material Mediated Pyrogenicity Study | ISO 10993-11:2017: Meets the material mediated pyrogenicity requirement | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
- Chemotherapy Drug Permeation (ASTM D6978-05): The document specifies the standard used but does not provide the exact sample size for the test sets (number of gloves or replicates per drug). The data is generated from laboratory testing ("under the conditions of the study"). Data provenance is not explicitly stated but implies laboratory testing for regulatory submission.
- Dimensions, Physical Properties, Freedom from Holes, Powder-Free, Sterility: These tests refer to ASTM and ISO standards (e.g., ASTM D3577, ASTM D5151, ASTM D6124, ISO 11137-1). These standards typically define the sampling plans (e.g., AQL 1.5 for freedom from holes), but the specific number of units tested for this submission is not directly stated. Data provenance implies manufacturer's testing for regulatory submission.
- Biocompatibility (ISO 10993 series): These are biological evaluations. The document refers to "the conditions of the study" and "animal model" for acute systemic toxicity but does not provide specific sample sizes (e.g., number of animals used). Data provenance implies laboratory testing for regulatory submission.
- Human Skin Sensitization (Modified Draize-95 Test): This test was performed on "human subject tested." The sample size (number of human subjects) is not explicitly given, it ambiguously states "the human subject tested." Data provenance is from a clinical test as per FDA guidance.
- Endotoxin Study & Material Mediated Pyrogenicity Study: The document refers to "the conditions of the study" but does not provide sample sizes. Data provenance implies laboratory testing for regulatory submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This submission is for a physical device (surgical gloves) and its material properties, not an AI/algorithm-driven device requiring expert image interpretation or similar ground truth establishment. Therefore, the concept of "experts" establishing a ground truth in that context is not applicable here. The "ground truth" for the performance tests (e.g., breakthrough time, tensile strength) is established by the validated methodologies of the referenced ASTM and ISO standards.
4. Adjudication Method for the Test Set:
Not applicable in the context of material and physical property testing of a device like surgical gloves. Test results are objective measurements based on defined standard protocols.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This is not an AI device or a diagnostic imaging device where human reader performance is evaluated.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:
Not applicable as this is not an AI/algorithm device. The performance tests evaluate the physical gloves without any "human-in-the-loop" interaction in the testing methodology itself beyond conducting the tests.
7. The Type of Ground Truth Used:
- Objective Measurement Standards: For most physical and chemical properties (dimensions, strength, freedom from holes, powder, sterility, chemotherapy permeation, endotoxin, pyrogenicity), the "ground truth" is defined by the objective measurement criteria and methodologies specified in the referenced ASTM and ISO standards. The results are quantitative measurements against these predefined thresholds.
- Biological Response in Models: For biocompatibility tests (cytotoxicity, skin irritation, sensitization, acute systemic toxicity), the "ground truth" is established by observing biological responses in in vitro or in vivo (animal) models as per ISO 10993 standards and the Modified Draize-95 Test for human skin sensitization.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device that requires a training set. The device is a manufactured physical product.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 23, 2023
Ansell Healthcare Products, LLC. Don Cronk Director, Regulatory Affairs for the Americas 2301 Robb Drive Reno, Nevada 89523
Re: K230079
Trade/Device Name: Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO, LZC, OPJ Dated: July 20, 2023 Received: July 24, 2023
Dear Don Cronk:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
{1}------------------------------------------------
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801; medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Bifeng Qian -S
BiFeng Qian, M.D., Ph.D Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230079
Device Name
Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential
Indications for Use (Describe)
These surgical gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves were tested for use with chemotherapy drugs, have low dermatitis potential, and are nonpyrogenic. 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.
Tested chemotherapy drugs are as follows:
| Test Chemotherapy drug & Concentration | Breakthrough Detection Time (Minutes) |
|---|---|
| Bleomycin (15 mg/ml) | >240 |
| Busulfan (6 mg/ml) | >240 |
| Carmustine (BCNU) (3.3 mg/ml) | 12.6 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 |
| Cytarabine (100 mg/ml) | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 |
| Daunorubicin (5 mg/ml) | >240 |
| Docetaxel (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (Toposar) (20.0 mg/ml) | >240 |
| Fludarabine (25 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Gemcitabine (Gemzar) (38 mg/ml) | >240 |
| Idarubicin (1 mg/ml) | >240 |
| Ifosfamide (50.0 mg/ml) | >240 |
| Irinotecan (20.0 mg/ml) | >240 |
| Mechlorethamine HCI (1.0 mg/ml) | >240 |
| Melphalan (5 mg/ml) | >240 |
| Methotrexate (25 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 |
| Oxaliplatin (2.0 mg/ml) | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| Paraplatin (10 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 26.6 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
| Ellence (2 mg/ml) | >240 |
| Rituximab (10 mg/ml) | >240 |
Please note that the following drugs have extremely low permeation times: Carmustine (BCNU) 12.6 minutes and Thiotepa: 26.6 minutes. Warning Do not use with Carmustine and Thiotepa
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Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510K Summary
K230079 Submitter: Ansell Healthcare Products LLC. 2301 Robb Drive Reno, NV 89523 USA
Contact Person(s):
Don Cronk Assoc. Director, Regulatory Phone: 775-750-1723 don.cronk@ansell.com
Carson Delaloye Sr. Administrator, Quality Phone: 530-401-8977 carson.delaloye@ansell.com
Date Prepared: August 23, 2023
Name of Device
| Trade Names: | Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugsand Low Dermatitis Potential |
|---|---|
| Common Name: | Surgeon's Gloves |
| Classification Name: | Non-Powdered Surgeon's Glove |
| Classification Regulation: | 21 CFR 878.4460 |
| Device Class: Product | I |
| Code: Classification | KGO, LZC, OPJ |
| Panel: 510k Number | General and Plastic Surgery |
| Assigned: | K230079 |
Legally Marketed Predicate Device
K190018-Gammex Non-Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs
Device Description
Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential are sterile and disposable devices. Gloves are made of synthetic polyisoprene rubber, are white in color, and are available in sizes 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, and 9.0. A polyurethane polymer coating is applied to the inner surface of the glove to make donning easy.
Indication for Use Statement
These surgical gloves are intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves were tested for use with chemotherapy drugs, have low dermatitis potential, and are non-pyrogenic. 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.
Please note that the following drugs have extremely low permeation times: Carmustine (BCNU) 12.6 minutes and Thiotepa: 26.6 minutes. Warning Do not use with Carmustine and Thiotepa.
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Chemotherapy Drug Permeation
(Minimum breakthrough detection time in minutes) (ASTM D6978-05 2019)
| TEST CHEMOTHERAPY DRUG ANDCONCENTRATION | MINIMUMBREAKTHROUGHTIME (Minutes) |
|---|---|
| Blenoxane (15 mg/ml) | >240 |
| Busulfan (6 mg/ml) | >240 |
| Carmustine (BCNU) (3.3 mg/ml) | 12.6 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (Cytoxan) (20.0 mg/ml) | >240 |
| Cytarabine (100 mg/ml) | >240 |
| Dacarbazine (DTIC) (10.0 mg/ml) | >240 |
| Daunorubicin (5 mg/ml) | >240 |
| Docetaxel (10.0 mg/ml) | >240 |
| Doxorubicin Hydrochloride (2.0 mg/ml) | >240 |
| Etoposide (Toposar) (20.0 mg/ml) | >240 |
| Fludarabine (25 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Gemcitabine (Gemzar) (38mg/ml) | >240 |
| Idarubicin (1 mg/ml) | >240 |
| Ifosfamide (50.0 mg/ml) | >240 |
| Irinotecan (20.0 mg/ml) | >240 |
| Mechlorethamine HCI (1.0 mg/ml) | >240 |
| Melphalan (5 mg/ml) | >240 |
| Methotrexate (25 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2.0 mg/ml) | >240 |
| Oxaliplatin (2.0 mg/ml) | >240 |
| Paclitaxel (Taxol) (6.0 mg/ml) | >240 |
| Paraplatin (10 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 26.6 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
| Ellence (2 mg/ml) | >240 |
| Rituximab (10 mg/ml) | >240 |
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| Technical Characteristic Comparison Table | |||||
|---|---|---|---|---|---|
| Predicate Device | Subject Device | Comparison | |||
| Trade Name | Gammex Non-Latex PI WhitePolyisoprene Surgical Gloves Tested forUse with Chemotherapy Drugs | Polyisoprene Surgical Glove Testedfor Use with Chemotherapy Drugs andLow Dermatitis Potential | Different | ||
| 510(k) Number | K190018 | K230079 | Different | ||
| Submitter | Ansell Healthcare Products LLC | Ansell Healthcare Products LLC | Same | ||
| Product Code | KGO | KGO, LZC, OPJ | Same | ||
| RegulationNumber | 21 CFR 878.4460 | 21 CFR 878.4460 | Same | ||
| RegulationName | Non-powdered Surgeon's glove | Non-powdered Surgeon's glove | Same | ||
| Indicationsfor Use | Gammex Non-Latex PI White Surgical Gloves Testedfor Use with Chemotherapy Drugs are intended to beworn by operating room personnel to protect asurgical wound from contamination. These gloveswere tested for use with Chemotherapy Drugs as perASTM D6978-05 Standard Practice for Assessment ofMedical Gloves to Permeation by ChemotherapyDrugs. | These surgical gloves are intended to be worn byoperating room personnel to protect a surgical woundfrom contamination. These gloves were tested for usewith chemotherapy drugs, have low dermatitispotential, and are non-pyrogenic. These gloves weretested for use with Chemotherapy Drugs as per ASTMD6978-05 Standard Practice for Assessment of MedicalGloves to Permeation by Chemotherapy Drugs. | Similar | ||
| Tested chemotherapy drugs are as follows:TESTCHEMOTHERAPYDRUGANDCONCENTRATION | MINIMUMBREAKTHROUGHDETECTIONTIME (Minutes) | TEST CHEMOTHERAPYDRUGANDCONCENTRATION | MINIMUMBREAKTHROUGHTIME (Minutes) | ||
| Blenoxane (15mg/ml) | >240 | Blenoxane (15mg/ml) | >240 | ||
| Busulfan (6 mg/ml) | >240 | Busulfan (6 mg/ml) | >240 | ||
| Carmustine(BCNU)(3.3 mg/ml) | 10.2 | Carmustine (BCNU)(3.3 mg/ml) | 12.6 | ||
| Cisplatin (1.0 mg/ml) | >240 | Cisplatin (1.0 mg/ml) | >240 | ||
| Cyclophosphamide(Cytoxan) (20.0mg/ml) | >240 | Cyclophosphamide(Cytoxan) (20.0mg/ml) | >240 | ||
| Cytarabine (100mg/ml) | >240 | Cytarabine (100mg/ml) | >240 | ||
| Dacarbazine (DTIC)(10.0 mg/ml) | >240 | Dacarbazine (DTIC)(10.0 mg/ml) | >240 | ||
| Daunorubicin (5mg/ml) | >240 | Daunorubicin (5mg/ml) | >240 | ||
| Docetaxel (10.0mg/ml) | >240 | Docetaxel (10.0mg/ml) | >240 | ||
| DoxorubicinHydrochloride (2.0mg/ml) | >240 | DoxorubicinHydrochloride (2.0mg/ml) | >240 | ||
| Etoposide (Toposar)(20.0 mg/ml) | >240 | Etoposide (Toposar)(20.0 mg/ml) | >240 | ||
| Fludarabine (25mg/ml) | >240 | Fludarabine (25mg/ml) | >240 | ||
| Fluorouracil (50.0mg/ml) | >240 | Fluorouracil (50.0mg/ml) | >240 | ||
| Gemcitabine(Gemzar) (38 mg/ml) | >240 | Gemcitabine(Gemzar) (38 mg/ml) | >240 | ||
| Idarubicin (1 mg/ml) | >240 | Idarubicin (1 mg/ml) | >240 | ||
| Ifosfamide (50.0mg/ml) | >240 | Ifosfamide (50.0mg/ml) | >240 | ||
| Irinotecan (20.0mg/ml) | >240 | Irinotecan (20.0mg/ml) | >240 | ||
| Mechlorethamine HCI(1.0 mg/ml) | >240 | Mechlorethamine HCI(1.0 mg/ml) | >240 | ||
| Melphalan (5 mg/ml) | >240 | Melphalan (5 mg/ml) | >240 | ||
| Methotrexate (25mg/ml) | >240 | Methotrexate (25mg/ml) | >240 | ||
| Mitomycin C (0.5mg/ml) | >240 | Mitomycin C (0.5mg/ml) | >240 | ||
| Mitoxantrone (2.0mg/ml) | >240 | Mitoxantrone (2.0mg/ml) | >240 | ||
| Oxaliplatin (2.0mg/ml) | >240 | Oxaliplatin (2.0mg/ml) | >240 | ||
| Paclitaxel (Taxol) (6.0mg/ml) | >240 | Paclitaxel (Taxol) (6.0mg/ml) | >240 | ||
| Paraplatin (10 mg/ml) | >240 | Paraplatin (10 mg/ml) | >240 | ||
| Thiotepa (10.0 mg/ml) | 11.5 | Thiotepa (10.0 mg/ml) | 26.6 | ||
| Vincristine Sulfate (1.0mg/ml) | >240 | Vincristine Sulfate (1.0mg/ml) | >240 | ||
| Ellence (2 mg/ml) | >240 | Ellence (2 mg/ml) | >240 | ||
| Rituximab (10 mg/ml) | >240 | Rituximab (10 mg/ml) | >240 | ||
| Please note that the following drugs haveextremely low permeation times:Carmustine (BCNU) 10.2 minutes andThiotepa: 11.5 minutes. Warning Do notuse with Carmustine and Thiotepa | Please note that the following drugs haveextremely low permeation times:Carmustine (BCNU) 12.6 minutes andThiotepa: 26.6 minutes. Warning Do notuse with Carmustine and Thiotepa | ||||
| Prescriptionor Over-TheCounter-Use | Over-The-Counter-Use | Over-The-Counter-Use | Same | ||
| Materials | Synthetic polyisoprene rubber | Synthetic polyisoprene rubber | Same | ||
| Coating | Polyurethane polymer inner coating toaid donning | Polyurethane polymer inner coating toaid donning | Same | ||
| Design | Single use | Single use | Same | ||
| Powder-free | Powder-free | Same | |||
| Hand Specific | Hand Specific | Same | |||
| Beaded cuff | Beaded cuff | Same | |||
| Color | White | White | Same | ||
| Sizes | 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0 | 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0 | Same | ||
| Dimensions andphysicalproperties | Meets ASTM D3577 | Meets ASTM D3577 | Same | ||
| Sterility | Sterile | Sterile | Same | ||
| Sterilizationmethod | Irradiation | Irradiation | Same |
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| SterilityAssurance Level(SAL) | 10-6 SAL | 10-6 SAL | Same |
|---|---|---|---|
| Freedom fromholes | Meets ASTM D3577-09(2015)Inspection level/AQL: GI/AQL 1.5 | Meets ASTM D3577-09(2015)Inspection level/AQL: GI/AQL 1.5 | Similar |
| Powder-Free | Meets ASTM D 6124-06. MeetsApplicable Definition for Powder Free; ≤ 2mg per glove | Meets ASTM D 6124-06. MeetsApplicable Definition for Powder Free; ≤ 2 mg per glove | Same |
| Protein Content | Not Applicable | Not Applicable | Same |
| In VitroCytotoxicity | Failed. Cytotoxicity Grade 4. | Failed. Cytotoxicity Grade 4. | Same |
| BiocompatibilityPrimary SkinIrritationISO 10993-10:2010 | Under the conditions of the study (perISO 10993-10), the device is not anirritant | Under the conditions of the study (perISO 10993-10), the device is not anirritant | Same |
| BiocompatibilityDermalSensitization -ISO 10993-10:2010 | Under the conditions of the study(per ISO 10993-10), not a sensitizer | Under the conditions of the study(per ISO 10993-10), not a sensitizer | Same |
| BiocompatibilityAcute SystemicToxicity - ISO10993-11: 2006 | Under the conditions of the study, therewas no mortality or evidence of acutesystemic toxicity | Under the conditions of the study,there was no mortality or evidenceof acute systemic toxicity | Same |
| Material-MediatedPyrogenicity | No pyrogenicity claims made | Under the conditions of the study,both inner and outer surface isnon-pyrogenic | Different |
| BacterialEndotoxin | No endotoxin claims | Under the conditions of the study,test results indicate low endotoxinlevel | Different |
| Low DermatitisPotential | No low dermatitis potential claims made | Under the conditions of the study,the test results demonstrated lowdermatitis potential for the subjectglove. | Different |
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The subject device is manufactured from synthetic polyisoprene rubber with polyurethane polymer inner coating to aid donning. The predicate device is manufactured from synthetic polyisoprene rubber with polyurethane polymer inner coating to aid donning.
The subject device meets the applicable requirements for surgeon's gloves with regards to dimensions and sizes, physical properties, freedom from holes, and powder residues, as found in the following standards: ASTM D3577, ASTM D5151 and ASTM D6124. The subject device passes biological reactivity testing for dermal sensitization, acute systemic toxicity, and material-mediated pyrogenicity in accord with the ISO 10993-10 and ISO 10993-11.
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Summary of Non-clinical Testing
| TechnologicalCharacteristics | Purpose | Standard/Test/FDA GuidanceCriteria | Result Summary |
|---|---|---|---|
| Dimensions | To evaluate thedimension of the glove | ASTM D3577Meets ASTM D3577 requirementsfor length, width and thickness | Pass |
| Length | Minimum 265mm | Pass | |
| Palm Width (size) | (mm) | Pass | |
| 5.5 | 70±6 | Pass | |
| 6.0 | 76±6 | Pass | |
| 6.5 | 83±6 | Pass | |
| 7.0 | 89±6 | Pass | |
| 7.5 | 95±6 | Pass | |
| 8.0 | 102±6 | Pass | |
| 8.5 | 108±6 | Pass | |
| 9.0 | 114±6 | Pass | |
| Thickness | To evaluate the thicknessof the glove | (mm) | Pass |
| Finger | Minimum 0.10 | Pass | |
| Palm | Minimum 0.10 | Pass | |
| Cuff | Minimum 0.10 | Pass | |
| PhysicalProperties | To evaluate the tensilestrength, ultimateelongation, and stress at500% elongation | ASTM D3577-19Meets ASTMD3577-19requirements for tensile strength,ultimate elongation and stress at500% elongation before and afteraccelerated aging for syntheticsurgical gloves | Pass |
| Freedom fromholes | To evaluate the presenceof holes in the gloves | ASTM D3577-19 ASTM D5151-06Meets ASTM D3577-19andASTM D5151-06 requirementsAQL 1.5 | Pass |
| Powder-Free | To evaluate the level ofpowder on the gloves | ASTM D3577-19 ASTM D6124-06Meets applicable requirement forPowder Free; ≤ 2 mg per glove | Pass |
| Sterility | To demonstrate thesterilization performance | ANSI/AAMI/ISO 11137-1:2018Meets ANSI/AAMI/ISO 11137-1:2018 requirement of 106 SAL | Pass |
| TechnologicalCharacteristics | To Evaluate | Standard/Test/FDA Guidance | Result Summary |
| Biocompatibility: | |||
| ISO in vitrocytotoxicity | To evaluatecytotoxicity | ISO 10993-5:2009Non-cytotoxic | Under the conditions othe study, the devicewas found to becytotoxic and thereforethe device extractswere evaluated by ISO10993-11 – Test forsystemic toxicity. FromAcute Systemic Toxicitydevice extracts, thedevice extracts did notelicit acute systemicresponse in the animalmodel. |
| ISO Skin IrritationStudy | To demonstrate low skinirritation potential | ISO 10993-10:2010Under the conditions of the study,not an irritant | Pass |
| ISO MaximizationSensitization Study | To demonstrate lowsensitization potential | ISO 10993-10:2010Under the conditions of the studynot a sensitizer | Pass |
| ISO AcuteSystemicToxicity Study | To demonstrate noacute systemictoxicity | ISO 10993-11:2006Under the conditions of the study,there was no morality or evidenceof acute systemic toxicity | Pass |
| ChemotherapyPermeationStandard | To demonstratechemotherapy drugbarrier performance | ASTM D6978 - 05(2019)Under the conditions of the studythe permeation is acceptablefor the drugs tested for use withthe subject gloves | Pass |
| Human SkinSensitization | To demonstrate lowdermatitis potential | Modified Draize-95 TestUnder the conditions of the study,not a sensitizer. | Pass |
| Endotoxin Study | To demonstrate lowendotoxin levels | Less than 20.0 EU/device | Pass |
| Material MediatedPyrogenicity Study | To demonstrate lowpyrogenicity potential | ISO 10993-11:2017Under the conditions of the study,has met the material mediatedpyrogenicity requirement | Pass |
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Clinical Summary:
Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis potential were tested in accordance with Modified Draize-95 Test, per FDA's guidance document "Guidance for Industry and FDA Reviewers/Staff: Premarket Notification [510k] Submissions for Testing Skin Sensitization Chemicals in Natural Rubber Products 1999". Both the inner and the outer surfaces of the subject glove were tested. The results showed low dermatitis potential for the human subject tested.
Conclusion
The conclusions drawn from the clinical and non-clinical tests performed demonstrate that the subject device, Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential, is as safe, as effective, and performs as well as or better than the predicate device K190018.
§ 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).