Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs
Device Facts
| Record ID | K190018 |
|---|---|
| Device Name | Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs |
| Applicant | Ansell Healthcare Products, LLC |
| Product Code | KGO · General, Plastic Surgery |
| Decision Date | May 23, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4460 |
| Device Class | Class 1 |
Indications for Use
Gammex Non Latex PI White 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 as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
Device Story
Gammex Non Latex PI White Surgical Gloves are sterile, disposable, hand-specific surgical gloves made of synthetic polyisoprene rubber with a polyurethane inner coating to facilitate donning. Used by operating room personnel to protect surgical wounds from contamination. The device is tested for permeation resistance against a panel of chemotherapy drugs per ASTM D6978-05. The gloves provide a physical barrier; they do not involve active processing or software. The primary benefit is protection of the surgical site and the wearer from potential exposure to chemotherapy agents, excluding specific drugs with low breakthrough times (Carmustine and Thiotepa).
Clinical Evidence
Bench testing only. No clinical data. Performance verified against ASTM D3577 (dimensions, physical properties), ASTM D5151 (freedom from holes), ASTM D6124 (powder content), and ASTM D6978-05 (chemotherapy drug permeation). Biocompatibility testing performed per ISO 10993-5, 10, and 11, confirming the device is not an irritant or sensitizer and shows no systemic toxicity.
Technological Characteristics
Synthetic polyisoprene rubber; polyurethane inner coating. Sterile, powder-free, hand-specific, beaded cuff. Sterilized via radiation (10^-6 SAL). Dimensions and physical properties meet ASTM D3577-09. Biocompatibility per ISO 10993. Chemotherapy permeation testing per ASTM D6978-05.
Indications for Use
Indicated for use by operating room personnel to protect surgical wounds from contamination. Tested for use with specific chemotherapy drugs per ASTM D6978-05. Contraindicated for use with Carmustine and Thiotepa due to low permeation times.
Regulatory Classification
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.
Predicate Devices
- Derma Prene Isotouch Green Sterile Powder-Free Polyisoprene Surgical Gloves, Tested for Use with Chemotherapy Drugs (K111139)
Submission Summary (Full Text)
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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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 23, 2019
Ansell Healthcare Products, LLC. Don Cronk Director, Regulatory Affairs for the Americas 2301 Robb Drive Reno, Nevada 89523
Re: K190018
Trade/Device Name: Gammex Non Latex Polyisoprene White Surgical Gloves Tested for Use with Chemotherapy Drugs Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I Product Code: KGO Dated: April 16, 2019 Received: April 17, 2019
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.
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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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For David Krause, PhD Acting 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) K190018
Device Name
Gammex Non Latex Polyisoprene White Surgical Gloves Tested for Use with Chemotherapy Drugs
#### Indications for Use (Describe)
Gammex Non Latex PI White Surgical Gloves Tested for Use with Chemotherapy Drugs 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 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 | Average Breakthrough Detection Times(Minutes) |
|----------------------------------------|-----------------------------------------------|
| Blenoxane, 15 mg/ml | >240 |
| Busulfan, 6 mg/ml | >240 |
| Carmustine (BCNU), 3.3 mg/ml | 10.2 |
| 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 | 11.5 |
| 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): 10.2 minutes and Thiotepa: 11.5 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 K190018
#### Submitter:
Ansell Healthcare Products LLC. 2301 Robb Drive Reno, NV 89523 USA
#### Contact Person:
Don Cronk Director of Regulatory Affairs Phone: 775-470-7106 don.cronk@ansell.com
#### Date Prepared: April 16th, 2019
#### Name of Device
Trade Names:
| | for Use with Chemotherapy Drugs |
|----------------------------|---------------------------------|
| Common Name: | Surgeon's Gloves |
| Classification Name: | Surgeon's Gloves |
| Classification Regulation: | 21 CFR 878.4460 |
| Device Class: | I |
| Product Code: | KGO |
| Classification Panel: | General and Plastic Surgery |
| 510k: | K190018 |
## Legally Marketed Predicate Device
K111139 - Derma Prene Isotouch Green Sterile Powder-Free Polyisoprene Surgical Gloves, Tested for Use with Chemotherapy Drugs.
Gammex Non Latex Polyisoprene White Surgical Gloves Tested
## Device Description
Gammex Non Latex Pl White Surgical Gloves are sterile and disposable devices. Gloves are made of synthetic polyisoprene rubber. A polyurethane polymer coating is applied to the inner surface of the glove to make donning easy. Ansell has performed independent laboratory testing on the already cleared device to support a labeling modification for the subject device that the gloves are safe and ling chemotherapy agents
## Indication for Use Statement
Gammex Non Latex PI White 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 as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs.
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Chemotherapy drug Permeation
(Average breakthrough detection time in minutes) (ASTM D6978-05)
| TEST CHEMOTHERAPY DRUG AND<br>CONCENTRATION | MINIMUM<br>BREAKTHROUGH<br>DETECTION TIME<br>(Sample 1,2,3)<br>(Minutes) |
|---------------------------------------------|--------------------------------------------------------------------------|
| Blenoxane (15 mg/ml) | >240 |
| Busulfan (6 mg/ml) | >240 |
| Carmustine (BCNU) (3.3 mg/ml) | 10.2 |
| 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) | 11.5 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
| Ellence (2 mg/ml) | >240 |
| Rituximab (10 mg/ml) | >240 |
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Please note that the following drugs have extremely low permeation times: Carmustine (BCNU): 10.2 minutes and Thiotepa: 11.5 minutes.
Warning: Do not use with Carmustine and Thiotepa
Technological Characteristics
| Technical Characteristic Comparison Table | | | |
|-----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Predicate Device | Subject Device | Comparison | |
| Trade Name | Derma Prene Isotouch Green Sterile<br>Powder-Free Polyisoprene Surgical<br>Gloves, Tested for Use with<br>Chemotherapy Drugs. | Gammex® Non-Latex PI White | Different |
| 510(k) Number | K111139 | K190018 | Different |
| Submitter | Ansell Healthcare Products LLC | Ansell Healthcare Products LLC | Same |
| Product Code | KGO | KGO | Same |
| Regulation<br>Number | 21 CFR 878.4460 | 21 CFR 878.4460 | Same |
| Regulation<br>Name | Non-powdered Surgeon's glove | Non-powdered Surgeon's glove | Same |
| Indications<br>for Use | Indications For Use:<br>These gloves are intended to be<br>worn by operating room personnel<br>to protect a surgical wound from<br>contamination, and are tested for<br>use with chemotherapy drugs. | These gloves are intended to be worn by operating<br>room personnel to protect a surgical wound from<br>contamination. These gloves were tested for use<br>with Chemotherapy Drugs as per ASTM D6978-05<br>Standard Practice for Assessment of Medical Gloves<br>to Permeation by Chemotherapy Drugs.<br>Tested chemotherapy drugs are as follows: | Similar<br>with the<br>exception<br>of added<br>Chemoth-<br>erapy<br>drugs |
| Chemotherapy Drug Permeation<br>(average breakthrough detection<br>time in minutes) (ASTM D6978-05) | TEST CHEMOTHERAPY<br>DRUG AND<br>CONCENTRATION | MINIMUM<br>BREAKTHROUGH<br>DETECTION<br>TIME | |
| | *Carmustine<br>15.5<br>Cyclophosphamide<br>>240<br>Doxorubicm Hydrochloride >240<br>Etoposide (Toposar)<br>>240<br>5-Fluorouracil<br>>240<br>Paclitaxel (Taxol)<br>>240<br>*ThioTEPA Methotrexate<br>15.5<br>Vincristine Sulfate<br>>240 | Blenoxane (15<br>>240<br>mg/ml)<br>Busulfan (6 mg/ml)<br>>240<br>Carmustine (BCNU)<br>10.2<br>(3.3 mg/ml)<br>Cisplatin (1.0 mg/ml)<br>>240<br>Cyclophosphamide<br>>240<br>(Cytoxan) (20.0 | |
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| Please note that Carmustine and<br>ThioTEPA have an extremely low<br>permeation time of 15.5 minutes. | Cytarabine (100<br>mg/ml) | >240 |
|-------------------------------------------------------------------------------------------------------|---------------------------------------------|------|
| | Dacarbazine (DTIC)<br>(10.0 mg/ml) | >240 |
| | Daunorubicin (5<br>mg/ml) | >240 |
| | Docetaxel (10.0<br>mg/ml) | >240 |
| | Doxorubicin<br>Hydrochloride (2.0<br>mg/ml) | >240 |
| | Etoposide (Toposar)<br>(20.0 mg/ml) | >240 |
| | Fludarabine (25<br>mg/ml) | >240 |
| | Fluorouracil (50.0<br>mg/ml) | >240 |
| | Gemcitabine<br>(Gemzar) (38 mg/ml) | >240 |
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| | | Idarubicin (1 mg/ml) | >240 |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-----------|
| | | Ifosfamide (50.0<br>mg/ml) | >240 |
| | | Irinotecan (20.0<br>mg/ml) | >240 |
| | | Mechlorethamine HCI<br>(1.0 mg/ml) | >240 |
| | | Melphalan (5 mg/ml) | >240 |
| | | Methotrexate (25<br>mg/ml) | >240 |
| | | Mitomycin C (0.5<br>mg/ml) | >240 |
| | | Mitoxantrone (2.0<br>mg/ml) | >240 |
| | | Oxaliplatin (2.0<br>mg/ml) | >240 |
| | | Paclitaxel (Taxol) (6.0<br>mg/ml) | >240 |
| | | Paraplatin (10 mg/ml) | >240 |
| | | Thiotepa (10.0 mg/ml) | 11.5 |
| | | Vincristine Sulfate (1.0<br>mg/ml) | >240 |
| | | Ellence (2 mg/ml) | >240 |
| | | Rituximab (10 mg/ml) | >240 |
| Prescription<br>or Over-<br>The<br>Counter-<br>Use | Over-The-Counter-Use | Over-The-Counter-Use | Same |
| Materials | Synthetic polyisoprene rubber | Synthetic polyisoprene rubber | Same |
| Coating | Polyurethane polymer inner coating to<br>aid donning | Polyurethane polymer inner coating to<br>aid donning | Same |
| Performance | Meets ASTM D3577-09 | Same | Same |
| Design | Single use | Single use | Same |
| | Sterile | Sterile | Same |
| | Powder-free | Powder-free | Same |
| | Hand Specific | Hand Specific | Same |
| | Beaded cuff | Beaded cuff | Same |
| Color | Green | White | Different |
| Dimensions and<br>physical<br>properties | Meets ASTM D3577 | Meets ASTM D3577 | Same |
| Sterilization<br>method | Radiation | Radiation | Same |
| Sterility<br>Assurance Level<br>(SAL) | 10-6 SAL | 10-6 SAL | Same |
| Freedom from<br>holes | Meets ASTM D3577-<br>09(2015)<br>Inspection level/AQL: GI/AQL 1.5 | Meets ASTM D3577-<br>09(2015)<br>Inspection level/AQL: GI/AQL 0.65 | Similar |
| Powder-Free | Meets ASTM D 6124-06. Meets<br>Applicable Definition for Powder Free; ≤ 2<br>mg per glove | Meets ASTM D 6124-06 The averaged<br>residual powder content for the glove<br>during process validation is 0.16mg per<br>glove | Same |
| Primary Skin<br>Irritation<br>ISO 10993-<br>10:2010 | Under the conditions of the study (per<br>ISO 10993-10), the device is not an<br>irritant | Under the conditions of the study (per<br>ISO 10993-10), the device is not an<br>irritant | Same |
| Dermal<br>Sensitization -<br>ISO 10993-<br>10:2010 | Under the conditions of the study (per<br>ISO 10993-10), not a sensitizer | Under the conditions of the study (per<br>ISO 10993-10), not a sensitizer | Same |
| Acute Systemic<br>Toxicity - ISO<br>10993-11: 2006 | Under the conditions of the study, there<br>was no mortality or evidence of systemic<br>toxicity | Under the conditions of the study, there<br>was no mortality or evidence of systemic<br>toxicity | Same |
| Shelf Life | 3 years | 3 years | Same |
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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.
# Non-Clinical Testing Summary:
Non-clinical testing was performed to verify that the subject device will meet the acceptance criteria of the performance test shown below.
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| Technological Characteristics | Standard/Test/FDA Guidance | Result Summary |
|-----------------------------------------|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dimensions | ASTM D3577 | Meets ASTM D3577<br>requirements for length,<br>width and thickness |
| Length | Minimum 265mm | Average 301mm |
| Palm Width (size) | (mm) | Average value in mm |
| 5.5 | 70±6 | 74 |
| 6.0 | 76±6 | 80 |
| 6.5 | 83±6 | 86 |
| 7.0 | 89±6 | 92 |
| 7.5 | 95±6 | 97 |
| 8.0 | 102±6 | 103 |
| 8.5 | 108±6 | 111 |
| 9.0 | 114±6 | 119 |
| Thickness | (mm) | Average value in mm |
| Finger | Minimum 0.10 | 0.233 |
| Palm | Minimum 0.10 | 0.172 |
| Cuff | Minimum 0.10 | 0.212 |
| Physical Properties | ASTM D3577-09 | Meets ASTM D3577-09<br>requirements for tensile<br>strength, ultimate<br>elongation and stress at<br>500% elongation before<br>and after accelerated aging<br>for synthetic surgical gloves |
| Freedom from holes | ASTM D3577-09<br>ASTM D5151-06 | Meets ASTM D3577-09<br>and ASTM D5151- 06<br>requirements of AQL 1.5 |
| Powder-Free | ASTM D3577-09<br>ASTM D6124-06 | Meets Applicable<br>requirement for Powder<br>Free; ≤ 2 mg per glove |
| Sterility | ANSI/AAMI/ISO 11137-1:2006 | Meets ANSI/AAMI/ISO<br>11137-1:2006 requirement<br>of 10-6SAL |
| Technological Characteristics | Standard/Test/FDA Guidance | Result Summary |
| Biocompatibility: | | |
| ISO in vitro cytotoxicity | ISO 10993-5:2009 | Under the conditions of the<br>study, the device was found<br>to be cytotoxic and<br>therefore the device<br>extracts were evaluated by<br>ISO 10993-11 - Test for<br>systemic toxicity. From<br>Acute Systemic Toxicity<br>device extracts, the device<br>extracts did not elicit a<br>systemic response in the<br>animal model. |
| ISO Skin Irritation Study | ISO 10993-10:2010 | Under the conditions of the<br>study, not an irritant |
| ISO Maximization Sensitization<br>Study | ISO 10993-10:2010 | Under the conditions of the<br>study, not a sensitizer |
| ISO Systemic Toxicity Study | ISO 10993-11:2006 | Under the conditions of the<br>study, there was no<br>mortality or evidence of<br>systemic toxicity |
| Chemotherapy Permeation<br>Standard | ASTM D6978 - 05(2013) | Under the conditions of the<br>study, the permeation is<br>acceptable |
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The subject device meets the applicable requirements for surgeon's gloves with regard to dimensions and sizes, physical properties, freedom from holes, powder residues, and protein content as found in the following standards: ASTM D3577, ASTM D5151 and ASTM D6124. The subject device passes biological reactivity testing for dermal sensitization, irritation, and acute systemic toxicity in accord with the ISO 10993-10 and ISO 10993-11.
## Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed device.
