Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs
Device Facts
| Record ID | K213289 |
|---|---|
| Device Name | Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs |
| Applicant | Ansell Healthcare Products, LLC |
| Product Code | KGO · General, Plastic Surgery |
| Decision Date | May 26, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4460 |
| Device Class | Class 1 |
Indications for Use
A powder-free surgeons' glove is intended to be worn by operating room personnel to protect a surgical wound from contamination. The glove system was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy testing was carried out on the system as a whole, including both the under-glove together. Please note that the following drugs have extremely low permeation times: 3.0 minutes and Thiotepa: 67.0 minutes. Warning: Do not use with Carmustine or Thiotepa.
Device Story
Gammex® PI Plus Glove-in-Glove™ System is a sterile, disposable, powder-free surgical glove system composed of a white outer glove and a green underglove, both made of synthetic polyisoprene. The underglove is mechanically inserted into the outer glove during manufacturing to facilitate a single donning event for double gloving. Used by operating room personnel to protect surgical wounds from contamination. The device provides a barrier against infectious materials and was tested for permeation resistance against various chemotherapy drugs per ASTM D6978-05. The system is ambidextrous and features a beaded cuff. Healthcare providers use the gloves as a protective barrier during surgical procedures; the chemotherapy permeation data informs the user of the device's protective limits against specific hazardous drugs. The device benefits patients and clinicians by reducing the risk of contamination and exposure to chemotherapy agents.
Clinical Evidence
No clinical studies were conducted. Substantial equivalence is supported by non-clinical bench testing, including physical properties (ASTM D3577), freedom from holes (ASTM D5151), powder residue (ASTM D6124), sterility (ISO 11137), and chemotherapy drug permeation (ASTM D6978-05). Biocompatibility was confirmed via ISO 10993 testing for skin irritation, sensitization, and acute systemic toxicity.
Technological Characteristics
Materials: Synthetic polyisoprene rubber. Coating: Polyacrylic polymer inner coating. Design: Ambidextrous, beaded cuff, glove-in-glove system. Sterilization: Gamma irradiation (10^-6 SAL). Standards: ASTM D3577-19, ASTM D6124-06, ASTM D5151-19, ASTM D412-16, ISO 11137-1:2006, ISO 10993-1:2018, ISO 10993-10:2010, ISO 10993-11:2017, ASTM D6978-05.
Indications for Use
Indicated for operating room personnel to protect surgical wounds from contamination. Ambidextrous, powder-free, synthetic polyisoprene surgical glove system. Contraindicated for use with Carmustine or Thiotepa.
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
- Biogel® PI UltraTouch S Surgical Glove, Biogel® PI Ultra Touch S Indicator Underglove (K190077)
Reference Devices
- Gammex® Non-Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs (K190018)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there 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 26, 2023
Ansell Healthcare Products, LLC Tammy McGriff Manager 2301 Robb Drive Reno, Nevada 89523
Re: K213289
Trade/Device Name: Gammex® PI Plus Glove-in-Glove System™ Tested For Use with Chemotherapy Drugs Regulation Number: 21 CFR 878.4460 Regulation Name: Non-Powdered Surgeon's Glove Regulatory Class: Class I, reserved Product Code: KGO, LZC, OPJ Dated: May 24, 2023 Received: May 26, 2023
Dear Tammy McGriff:
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
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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 mediation-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,
# Allan Guan -S
For 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) K213289
#### Device Name
Gammex® PI Plus Glove-in-Glove™ System Tested for Use with Chemotherapy Drugs
#### Indications for Use (Describe)
A powder-free surgeons' glove is intended to be worn by operating room personnel to protect a surgical wound from contamination. The glove system was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy testing was carried out on the system as a whole, including both the under-glove together. Please note that the following drugs have extremely low permeation times: 3.0 minutes and Thiotepa: 67.0 minutes. Warning: Do not use with Carmustine or Thiotepa.
| Test Chemotherapy drug & Concentration | Average Breakthrough Detection Time (Minutes) |
|----------------------------------------|-----------------------------------------------|
| Bleomycin - 15.0 mg/ml | >240 |
| Busulfan - 6.0 mg/ml | >240 |
| Carboplatin - 10 mg/ml | >240 |
| Carmustine - 3.3 mg/ml | 35.0 |
| Cisplatin - 1.0 mg/ml | >240 |
| Cyclophosphamide - 20.0 mg/ml | >240 |
| Cytarabine HCl - 100.0 mg/ml | >240 |
| Dacarbazine - 10.0 mg/ml | >240 |
| Daunorubicin HCl - 5.0 mg/ml | >240 |
| Docetaxel - 10.0 mg/ml | >240 |
| Doxorubicin HCl 2.0 mg/ml | >240 |
| Epirubicin - 2.0 mg/ml | >240 |
| Etoposide - 20.0 mg/ml | >240 |
| Fludarabine - 25 mg/ml | >240 |
| Fluorouracil - 50.0 mg/ml | >240 |
| Gemcitabine - 38.0 mg/ml | >240 |
| Idarubicin - 1.0 mg/ml | >240 |
| Ifosfamide - 50.0 mg/ml | >240 |
| Irinotecan - 20.0 mg/ml | >240 |
| Mechlorethamine HCl - 1.0 mg/ml | >240 |
| Melphalan - 5.0 mg/ml | >240 |
| Methotrexate - 25.0 mg/ml | >240 |
| Mitomycin C - 0.5 mg/ml | >240 |
| Mitoxantrone - 2.0 mg/ml | >240 |
| Oxaliplatin - 2.0 mg/ml | >240 |
| Paclitaxel - 6.0 mg/ml | >240 |
| Rituximab - 10.0 mg/ml | >240 |
| Thiotepa - 10.0 mg/ml | 67.0 |
| Vincristine Sulfate - 1.0 mg/ml | >240 |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
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#### 510KSummary
#### 510(k) Number:
K213289
#### Submitter:
Ansell HealthcareProducts LLC. 2301 Robb Drive Reno, NV 89523
#### Contact Person(s):
Tammy McGriff Manager, Regulatory Affairs/Quality Assurance Phone: 334-796-9361 Email: tammy.mcgriff@ansell.com
Carson Delaloye Senior Coordinator, Regulatory Affairs Phone: 530-401-8977 Email: carson.delaloye@ansell.com
#### Date Prepared
May 24, 2023
#### Name of Device
| Trade Names: | Gammex® PI Plus Glove-in-Glove™ System Tested for Use<br>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, OPJ, LZC |
| Classification Panel: | General and Plastic Surgery |
#### Legally Marketed Predicate Device
K190077 – Biogel® PI UltraTouch S Surgical Glove, Biogel® PI Ultra Touch SIndicator Underglove
#### Legally Marketed Reference Device
K190018 - Gammex® Non-Latex Pl White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs
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#### Device Description
Gammex® Pl Plus Glove-in-Glove™ System tested for use with Chemotherapy Drugs is a sterile and disposable device. This glove system ismade of synthetic polyisoprene rubber. Gammex® Pl Plus Glove- in-Glove™ System Tested for Use with Chemotherapy Drugs is comprised of a single-use, sterile, white outer glove, which is a disposable, powder-free surgical glove made from synthetic polyisoprene and a single-use, sterile, green underglove which is a disposable, powder-free surgical glove made from syntheticpolyisoprene. The Gammex® Pl PlusGlove-in-Glove™ system Testedfor Use with Chemotherapy Drugs is comprised of the underglove being mechanically inserted into the outer glove prior to packing and sterilization. There is no adhesive present between the two gloves. This results in quick double gloving with only one donning event.
Gammex® PI Plus Glove™ System Tested for Use with Chemotherapy Drugs conforms to the following FDA recognized consensus standards: ASTM D3577-19, ASTM D6124-06, ASTM D5151-19, ASTM D412-16, ISO 11137-1:2006, ISO 10993-1:2018, ISO 10993-10:2010, ISO 10993-10:2010, ISO 10993-11:2017, & ASTM D6978-05.
Gammex® PI Plus Glove-in-Glove™ System Tested for Use with Chemotherapy Drugs is available in the following sizes: 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0
#### Indication for Use Statement
Gammex® PI Plus Glove-in-Glove™ System Tested for Use with Chemotherapy Drugs
A powder-free surgeons' glove is intended to be worn by operating room personnel to protect a surgical wound from contamination. The glove system was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy testing was carried out on the system as a whole, including both the under-glove & outer glove together. Please note that the following drugs have extremely low permeation times: Carmustine: 35.0 minutes and Thiotepa: 67.0 minutes. Warning: Do not use with Carmustine or Thiotepa.
| TEST CHEMOTHERAPY DRUG AND<br>CONCENTRATION | AVERAGEMINIMUM<br>BREAKTHROUGH<br>DETECTIONTIME<br>(Minutes) |
|---------------------------------------------|--------------------------------------------------------------|
| Bleomycin (15.0 mg/ml) | >240 |
| Busulfan (6.0 mg/ml) | >240 |
| Carboplatin (10.0 mg/ml) | >240 |
| Carmustine (3.3 mg/ml) | 35.0 |
| Cisplatin (1.0 mg/ml) | >240 |
| Cyclophosphamide (20.0 mg/ml) | >240 |
| Cytarabine HCl (100.0 mg/ml) | >240 |
| Dacarbazine (10.0 mg/ml) | >240 |
| Daunorubicin HCl (5.0 mg/ml) | >240 |
| Docetaxel (10.0 mg/ml) | >240 |
| Doxorubicin HCl (2.0 mg/ml) | >240 |
| Epirubicin (2.0 mg/ml) | >240 |
| Etoposide (20.0 mg/ml) | >240 |
| Fludarabine (25.0 mg/ml) | >240 |
| Fluorouracil (50.0 mg/ml) | >240 |
| Gemcitabine (38.0 mg/ml) | >240 |
| Idarubicin (1.0 mg/ml) | >240 |
| Ifosfamide (50.0 mg/ml) | >240 |
| Irinotecan (20.0mg/ml) | >240 |
| Mechlorethamine HCI (1.0 mg/ml) | >240 |
| Melphalan (5.0mg/ml) | >240 |
| Methotrexate (25.0 mg/ml) | >240 |
| Mitomycin C (0.5 mg/ml) | >240 |
| Mitoxantrone (2.0mg/ml) | >240 |
| Oxaliplatin (2.0 mg/ml) | >240 |
| Paclitaxel (6.0 mg/ml) | >240 |
| Rituximab (10.0 mg/ml) | >240 |
| Thiotepa (10.0 mg/ml) | 67.0 |
| Vincristine Sulfate (1.0 mg/ml) | >240 |
Tested chemotherapy drugs are as follows:
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## Technological Characteristics:
| | Predicate Device | Proposed Subject Device | Comparison |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Trade name | Biogel® PI UlltraTouch S<br>Surgical Glove, Biogel® PI<br>Ultra Touch S Indicator<br>Glove | Gammex® PI Plus Glove-in-<br>Glove™ System Tested for<br>Use with Chemotherapy<br>Drugs | Different - New<br>Product |
| 510kNumber | K190077 | K213289 | Different -New<br>510(k) |
| Product Owner | Mölnlycke Health Care US,<br>LLC | Ansell Healthcare Products<br>LLC | Different - Separate<br>Businesses |
| Product Code | KGO | KGO, OPJ, LZC | Different -OPJ,LZC product<br>codes added for chemo |
| Regulation<br>Number | 21 CFR 878.4460 | 21 CFR 878.4460 | Same |
| Regulatory Class | I | I | Same |
| Regulation<br>Name | Non-powdered Surgeon's<br>Gloves | Non-powdered Surgeon's<br>glove | Same |
| Indicationsfor<br>Use | The Biogel PI UltraTouch S<br>Surgical Glove is a disposable<br>device made of polyisoprene, that<br>is intended to be worn on the<br>hands, usually in a surgical<br>setting, to provide a barrier<br>against potentially infectious<br>material and other contaminates.<br>The Biogel PI UltraTouch S<br>Indicator Underglove is a<br>disposable device made of<br>polyisoprene, blue in color, that is<br>intended to be worn on the<br>hands, usually in a surgical<br>setting, to provide a barrier<br>against potentially infectious<br>material and other contaminants | A powder-free surgeons' glove is<br>intended to be worn by operating<br>room personnel to<br>protect a surgical wound from<br>contamination. The glove system<br>was tested for use with<br>Chemotherapy Drugs as per ASTM<br>D6978-05 Standard Practice for<br>Assessment of Medical Gloves to<br>Permeation by Chemotherapy<br>Drugs. Chemotherapy testing was<br>carried out on the system as a<br>whole, including both the under-<br>glove & outer-glove together.<br>Please note that the following<br>drugs have extremely low<br>permeation times: Carmustine:<br>35.0 minutes and Thiotepa: 67.0<br>minutes. Warning: Do not use with<br>Carmustine or Thiotepa. | Different |
| Material<br>Composition | Synthetic polyisoprene<br>rubber | Synthetic polyisoprene<br>rubber | Same |
| Coating | Hydrogel Polymer Coating | Polyacrylic Polymer Inner Coating | Different |
| Design | Single use | Single use | Same |
| | Powder-free | Powder-free | Same |
| | Hand Specific | Ambidextrous | Different |
| | Beaded cuff | Beaded cuff | Same |
| Color | Under Glove- Blue<br>OuterGlove-Straw (Natural) | Under Glove—Green<br>Outer Glove - White | Different - Changed<br>Color |
| Labeling | Surgeon's Gloves | Surgeon's Gloves | Same |
| Shelf Life | 3 Years | No claimed shelf life | Different |
| | Predicate Device | Proposed Subject Device | Comparison |
| Performance<br>a. Dimensions | Meets ASTM D3577-09 (2015)<br>requirements | Meets ASTM D3577-19<br>requirements | Same |
| b. Physical<br>Properties | Meets ASTM D3577-09 (2015)<br>requirements | Meets ASTM D3577-19<br>requirements | Same |
| c. Freedom from<br>holes | Meets ASTM D3577-09 (2015)<br>AQL Meets CFR 800.20<br>Requirements | Meets ASTM D3577- 19 Gl,<br>AQL 1.5 Requirements | Same |
| d. Powder<br>Residual | Meet applicable definition for<br>powder free per ASTM<br>D3577-19; ≤ 2mg per glove | Meet applicable definition for<br>powder free per ASTM<br>D3577-19; ≤ 2mg per glove | Same |
| e. Sterility | Sterile | Sterile | Same |
| Biocompatibility<br>Skin Irritation | Passes Primary Skin Irritation test<br>per ISO 10993-10, Biological<br>Evaluation of medical devices,<br>Part 10: Test for irritation and<br>skin sensitization | Passes Primary Skin Irritation test<br>per ISO 10993-10, Biological<br>Evaluation of medical devices,<br>Part 10: Test for irritation and<br>skin sensitization | Same |
| Biocompatibility<br>Sensitization | Passes Dermal Sensitization test<br>per ISO 10993-10, Biological<br>Evaluation of medical devices,<br>Part 10: Test for irritation and<br>skin sensitization | Passes Dermal Sensitization test<br>per ISO 10993-10, Biological<br>Evaluation of medical devices,<br>Part 10: Test for irritation and<br>skin sensitization | Same |
| Biocompatibility<br>Acute Systemic<br>Toxicity | Passes Acute Systemic Toxicity<br>Test per ISO 10993-11, Biological<br>Evaluation of medical devices,<br>Part 11: Test for systemic toxicity | Passes Acute Systemic Toxicity Test<br>per ISO 10993-11, Biological<br>Evaluation of medical devices,<br>Part 11: Test for systemic toxicity | Same |
| Sterilization<br>Method | Gamma Irradiation | Gamma Irradiation | Same |
| Sterilization<br>Information | Meets ANSI/AAMI/ISO 11137-<br>1:2006<br>requirement of 10-6 SAL. | Meets ANSI/AAMI/ISO 11137-<br>1:2006<br>requirement of 10-6 SAL. | Same |
| Prescription or<br>Over the<br>counter | Over the Counter | Over the Counter | Same |
## Technological Characteristics Comparison Table for Predicate Device
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## Itemized List of Differences Between Predicate and Proposed:
- Trade Name
- The difference is that the trade names are different due to the gloves being separate styles from sperate O owners. There is no impact on the safety or effectiveness with the changing of device names.
- 510k Number
- There are different 510k numbers because they are different owners. There is no impact o on the safety or effectiveness with the predicate and proposed having different 510ks.
- Product Owner
- o There are different product owners for the proposed and predicate devices. There is no impact on safety or effectiveness with the predicate as this device has already been FDA cleared.
- FDA Product Code
- The predicate device does not have chemotherapy testing so there is no OPJ or LZC product code. O
- Indications for Use
- o There are different indications for use listed as the predicate device does not have chemotherapy data or indications for such use.
- Coating
- The sum total of all performance safety and efficacy testing presented indicates that the proposed device is as о safe and effective as the predicate and reference device.
- Design
- O The predicate device is listed as a hand specific glove, while the proposed is ambidextrous. There is no change to safety or efficacy as the gloves have different donning methods.
- Color
- The predicate device is two gloves, the outer being straw colored and the under glove being blue. O
- The proposed device is two gloves, the outer being white and the under glove being green. O
- O The sum total of all performance safety and efficacy testing presented indicates that the proposed device is as safe and effective as the predicate and reference device.
- Shelf Life ●
- O There is no claimed shelf life for the proposed device.
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## Technological Characteristics:
| | Reference Device | Proposed Subject Device | Comparison |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Trade name | Gammex® Non-Latex PI<br>White Polyisoprene Surgical<br>Gloves Tested for Use with<br>Chemotherapy Drugs | Gammex® PI Plus Glove-in-<br>Glove™ System Tested for<br>Use with Chemotherapy<br>Drugs | Different - New<br>Product |
| 510kNumber | K190018 | K213289 | Different - New<br>510(k) |
| Product Owner | Ansell Healthcare Products<br>LLC | Ansell Healthcare Products<br>LLC | Same |
| Product Code | KGO, OPJ | KGO, OPJ, LZC | Different -LZC added |
| Regulation<br>Number | 21 CFR 878.4460 | 21 CFR 878.4460 | Same |
| Regulatory Class | | | Same |
| Regulation<br>Name | Non-powdered Surgeon's<br>Gloves | Non-powdered Surgeon's<br>Gloves | Same |
| Indicationsfor<br>Use | Gammex Non Latex PI White<br>Surgical Gloves Tested for Use<br>with Chemotherapy Drugs are<br>intended to be worn by<br>operating room personnel to<br>protect a surgical wound from<br>contamination. These gloves<br>were tested for use with<br>Chemotherapy Drugs as per<br>ASTM D6978-05 Standard<br>Practices for Assessment of<br>Medical Gloves to Permeation<br>by Chemotherapy Drugs. | A powder-free surgeons' glove is<br>intended to be worn by operating<br>room personnel to<br>protect a surgical wound from<br>contamination. The glove<br>system was tested for use with<br>Chemotherapy Drugs as per<br>ASTM D6978-05 Standard<br>Practice for Assessment of<br>Medical Gloves to Permeation<br>by Chemotherapy Drugs.<br>Chemotherapy testing was<br>carried out on the system as a<br>whole, including both the<br>under-glove & outer-glove<br>together. Please note that the<br>following drugs have extremely<br>low permeation times:<br>Carmustine: 35.0 minutes and<br>Thiotepa: 67.0 minutes.<br>Warning: Do not use with<br>Carmustine or Thiotepa. | Different |
| Material<br>Composition | Synthetic polyisoprene<br>rubber | Synthetic polyisoprene<br>rubber | Same |
| Coating | Polyacrylic Polymer Inner<br>Coating | Polyacrylic Polymer Inner<br>Coating | Same |
| Design | Single use | Single use | Same |
| | Powder-free | Powder-free | Same |
| | Hand Specific | Ambidextrous | Different |
| | Beaded cuff | Beaded cuff | Same |
| Color | White | Under Glove – Green<br>Outer Glove - White | Different - Changed<br>Color |
| Labeling | Surgeon's Gloves | Surgeon's Gloves…
