Evaluating Chemotherapy Protection for Exam Gloves

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Chemotherapy protection is often a critical consideration when evaluating exam gloves. Evaluation criteria for selecting a glove used in chemotherapy should include validating that the gloves are:

1. Appropriately labeled

2. Appropriate for the drugs used within the facility

3. Tested against current standards

Appropriate Labeling Appropriate labeling is important to ensure that clinicians are aware of the level of protection they are using. The Food and Drug Administration (FDA) offers specific guidance when it comes to labeling exam gloves for chemotherapy. The excerpt below comes from the FDA’s Glove Guidance Manual 2008:

To market the glove for use in the handling and/or preparation of chemotherapeutic drugs, you should label the glove as a “Patient Examination Glove” or “Surgeon’s Glove” and “Tested for use with [name of chemotherapeutic drug(s)].”

We recommend that you include the following labeling information (to enable the user to make an appropriate product selection):

• chemicalresistancedata(testmethodused,chemicalstested),forconsumerreview, if desired,

• thestatement,“Glovesusedforprotectionagainstchemotherapydrugexposureshould be selected specifically for the type of chemicals used,” and

• instructionsforuserstoreviewdruglabelingormaterialsafetydatasheetsforthechemicals being used to determine an adequate level of protection for the intended use.

(FDA Glove Guidance Manual 2008 Pg. 22)

Healthcare workers should be cautious of exam gloves that do not carry this labeling because they could unknowingly expose themselves to chemotherapy drugs that may penetrate the gloves they use.

Chemotherapy Drug Usage Analysis It is important to understand whether the gloves under evaluation will protect against all the chemotherapy drugs used within a facility. Just because a glove is cleared by the FDA for use in chemotherapy does not mean that it will protect against all chemotherapy drugs. It is important that clinicians understand whether the gloves they are using have been tested against the drugs they are administering. This can be easily done by allowing clinicians the opportunity to review the chemical permeation labeling on the back of the exam glove package.

Tested Against Current Standards Users should also ensure the gloves they are using for chemotherapy have been tested against the most recent standards. The current standard for exam gloves used in chemotherapy is ASTM D6978-05 “Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs”. Prior to ASTM D6978-05 many exam gloves were tested against ASTM F739 “Resistance of Protective Clothing Materials to Permeation by Liquids or Gases Under Conditions of Continuous Contact”. ASTM D6978-05 uses ASTM F739 as a test method, but has a chemical permeation requirement that is 10 times more stringent than what is required by ASTM F739. Users of gloves tested under ASTM D6978-05 have a higher level of confidence that the gloves they are using are tested to the current, more stringent ASTM standard.

Taking into account these important considerations will help insure you have selected a glove that will effectively protect healthcare workers within your facility.

Chemotherapy LabelingKimberly-Clark believes that printing pertinent chemotherapy information on exam glove packaging including drugs tested against, breakthrough times and test method not only meets current regulatory requirements, but empowers glove users to understand the level of protection they are getting when they select an exam glove for use in chemotherapy. Not having this information readily available runs the risk that someone may inadvertently select a glove that is not suited for the drugs they are administering.

Product KC500

PURPLE NITRILE*KC300

STERLING* NitrileSemperCare NITRILE PF

Esteem Stretchy Nitrile SensiCare Ice

Supplier Kimberly-Clark Kimberly-Clark Sempermed Cardinal Medline

Test Method ASTM D6978-05 ASTM D6978-05 ASTM D6978-05 ASTM D6978-05 ASTM D6978-05

Chemotherapy Drugs Listed on the Package

Bleomycin sulfate (15.0 mg/ml)

X

Busulfan (6.0 mg/ml) X

Carboplatin/Paraplatin (10.0 mg/ml)

X

Carmustine (3.3 mg/ml) PurPle Nitrile-Xtra* X

Cisplatin (1.0 mg/ml) X X X

Cyclophosphamide (20.0 mg/ml)

X X X

Cytarabine HCl (100.0 mg/ml) X

Dacarbazine (10 mg/ml) X X X

Daunorubicin HCL (5.0 mg/ml) X

Docetaxel (10.0 mg/ml) X

Doxorubicin HCl (Adriamycin) (2.0 mg/ml)

X X X

Ellence (Epirubicin) (2.0 mg/ml)

X

Etoposide (20.0 mg/ml) X X X

Fludarabine (25.0 mg/ml) X

5-Fluorouracil (adrucil) (50.0 mg/ml)

X X X

Gemcitabine (38.0 mg/ml) X

Idarubicin (1.0 mg/ml) X

Ifosfamide (50.0 mg/ml) X X

Irinotecan (20.0 mg/ml) X

Mechlorethamine HCl (1.0 mg/ml)

X

Melphalan (5.0 mg/ml) X

Methotrexate (25.0 mg/ml) X X

Mitomycin (0.5 mg/ml) X

Mitoxantrone (2.0 mg/ml) X X

Paclitaxel (Taxol) (6.0 mg/ml) X X X

Rituximab (10.0 mg/ml) X

ThioTEPA (10.0 mg/ml) PurPle Nitrile-Xtra* X

Trisenox (0.1 mg/ml) X

Vincrinstine Sulfate (1.0 mg/ml)

X X X

Number of chemotherapy drugs listed on the package

29 12 9

SemperCare NITRILE PF - Code NIPFT203 - Lot 04201064871451 Esteem Stretchy Nitrile - Codes 8812N & 8856NM - Lots 4V10E014 & 3R10J024 SensiCare Ice - Code 486803 - Lot AM803783640

Package does not list drugs tested or breakthrough times

Package does not list drugs tested or breakthrough times

For more information, please call your sales representative or visit our web site at www.kchealthcare.com. *Registered Trademark or Trademark of Kimberly-Clark Worldwide, Inc. The COLOR PURPLE is a registered trademark of KCWW. The COLOR GREY and the COLOR LAVENDER are trademarks of KCWW. ©2011 KCWW. H02357 H1179-11-01