# K101596: Kimberly-Clark Purple Nitrile Powder-Free Exam Glove (Chemotherapy Glove) and Kimberly-Clark Purple Nitrile Xtra Powder- - Pathway: 510(k) (Traditional) - Applicant: Kimberly-Clark - Decided: Jul 21, 2010 after 43 days - Product code: LZC (Medical Glove, Specialty) - Device class: 1 - Regulation: 21 CFR 880.6250 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 2 generations back to K051347 (2005). 5 ancestors in all. 11 later devices descend from it; 2 cite it directly. 0 of 17 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K992162: Safeskin Purple Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic Drugs Labeling Claim, Safeskin Corp. (1999) Summary page 1. - K081089: Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with Chemotherapy Drug Use Claim, Kimberly-Clark Corp. (2008) Summary page 1. - K081260: Kimberly-Clark *Lavender* Nitrile Power-Free Exam Gloves, Kimberly-Clark Corp. (2008) Summary page 1. ## Most influential descendants - K113423: Kimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free Exam Glove (2012), 5 descendants of its own - K200633: Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove (2020), 4 descendants of its own - K160709: HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves (2016), 2 descendants of its own - K213929: Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (2022), 1 descendant of its own - K220547: PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves (2022), 1 descendant of its own ## Indications for use A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these chemotherapy gloves were tested for use with the following ding concentrations per ASTM D6978-05: The following drugs had NO breakthrough detected up to 240 minutes: Bleomycin sulfate (15.0mg/ml) Gemacitabine (38.0mg/mI) Busulifa (6.0mg/mi) Idarubicin (1.0mg/mi) Carboplatin (10.0mg/mi) Ifosfamide (50mg/mi) Cispiatin (I mg/ml) Irinotecan (20.0mg/mi) Cyclophosphamide (20 mg/mi) Mechlorethamine HCl (1.0mg/mil) Cytarabine HG! (100.0mg/mi) Melphalan (5.0mg/mI) Dacarbazine (10 mg/mi) Methotrexate (25.0mg/mi) Daunorubicin Hel (5.0mg/mi) Mitomycin (0.5mg/mi) Docetaxel (10.0mg/mI) Mitoxantrone (2 mg/mi) Doxorubicin HCI (Adriamycin) (2 mg/mi) Paclitaxei (Taxoi) (6 mg/mi) Elience (Epirubicin) (2.0mg/mil) Parapiatin (10.0mg/mi) Etoposide (20 mg/mI) Rituximab (10.0mg/mi) Fludarabine (25.0mg/mi) Trisenox (0.1Img/mi) Fluorouracil (adrucil) (50 mg/ml) Vincrinstine Suifate (I mg/mI) The following drugs showed breakthrough detected in less than' 30 minutes: Carmustine (3.3mg/ml) :1.8 minutes IThioTEPA l1O.Omg/ml):1. iue Warning - Not for Use with Carmustine and ThioTEPA A powder-free patient examination glove is a disposable devi ce intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. In addition, these chemotherapy gloves were tested for use with the following drug concentrations per ASTM D6978-05: The following drugs had NO breakthrough deetd up to 240 minutes: Bleomycin sulfate (1 5.0mg/mi) Gemcitabine (38.0mg/mi) Busulfan (6.0mg/mi) Idarubicin (1.0mg/mi) Carboplatin (10.0mg/nd) Ifosfamide (50mg/mi) Cispiatin (1 mg/mi) Irinotecan (20.0mg/mi) Cyclophosphamide (20 mg/mi) Mechlorethamnine HCI (1.0mng/mi) Cytarabine HCi (100.0mg/mi) Melphalan (5.0mg/mi) Dacarbazine (10 mg/mi) Methotrexate (25.0mg/mi) Daunorubicin Hci (5.0mg/mi) Mitomycin (0.5mg/mi) Docetaxel (iO.Omg/mi) Mitoxantrone (2 mg/ml) Doxorubicin HC1 (Adriamycin) (2 mg/ml) Paclitaxel (Taxoi) (6 mg/ndl) Ellence (Epirubicin) (2.0mg/mi) Parapatin (10.0mg/mi) Etoposide (20 mg/mi) Rituximab (10.0mg/mi) Fludarabine (25.0mg/mi) 1Trisenox (0. 1mg/md) Fluorouracil (adrucil) (50 mg/mi) IVincrinstine Sulfate (1 mg/mil) The following drugs showed breakthrough detected in less than 30 minutes: Carmustine (3.3mg/mI) :1.8 minutes ThioTEPA (10.Omg/ml) :1.7 minutes Warning - Not for Use with Carmustine and ThioTEPA A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A powder-free patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner- Source page: https://510kreport.com/device/K101596 Methodology: https://510kreport.com/methodology