# K102032: Kimberly-Clark Purple Nitrile Xtra* Sterile Powder-Free Exam Glove (Chemotherapy Glove) - 12 Sterile Pairs

- Pathway: 510(k) (Traditional)
- Applicant: Kimberly-Clark Corp.
- Decided: Sep 8, 2010 after 51 days
- Product code: LZA (Polymer Patient Examination Glove)
- 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 K992062 (1999). 6 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992062: Safeskin Sterile Purple Nitrile Examination Gloves, Safeskin Corp. (1999) Summary page 3.
- K992162: Safeskin Purple Powder-Free Nitrile Examination Gloves for Use with Chemotherapeutic Drugs Labeling Claim, Safeskin Corp. (1999) Summary page 3.
- K081089: Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with Chemotherapy Drug Use Claim, Kimberly-Clark Corp. (2008) Summary page 1.
- K081027: Kimberly-Clark Sterling Nitrile Powder-Free Exam Glove (Sterile), 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
- K160709: HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves (2016), 2 descendants of its own
- K243604: Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid (2025), 0 descendants of its own
- K243172: Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles (2025), 0 descendants of its own
- K192241: Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (2020), 0 descendants 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 drug concentrations per ASTM D6978-05: The following drugs had NO breakthrough detected up to 240 minutes: Bleomycin sulfate (15.0mg/ml) Idarubicin (1.0mg/ml) Busulfan (6.0mg/ml) Ifosfamide (50mg/ml) Carboplatin (10.0mg/ml) Irinotecan (20.0mg/ml) Cisplatin (1 mg/ml) Mechlorethamine HCl (1.0mg/ml) Cyclophosphamide (20 mg/ml) Melphalan (5.0mg/ml) Cytarabine HCl (100.0mg/ml) Methotrexate (25.0mg/ml) Dacarbazine (10 mg/ml) Mitomycin (0.5mg/ml) Daunorubicin HCl (5.0mg/ml) Mitoxantrone (2 mg/ml) Docetaxel (10.0mg/ml) Paclitaxel (Taxol) (6 mg/ml) Doxorubicin HCl (Adriamycin) (2 mg/ml) Paraplatin (10.0mg/ml) Ellence (Epirubicin) (2.0mg/ml) Rituximab (10.0mg/ml) Etoposide (20 mg/ml) ThioTEPA (10.0mg/ml) Fludarabine (25.0mg/ml) Trisenox (0.1mg/ml) Fluorouracil (adrucil) (50 mg/ml) Vincristine Sulfate (1 mg/ml) Gemcitabine (38.0mg/ml) Please note that the following drug has extremely low permeation times of less than 60 minutes: Carmustine (3.3 mg/ml) 48.6 minutes 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 drug concentrations per ASTM D6978-05: The following drugs had NO breakthrough detected up to 240 minutes: Bleomycin sulfate (15.0mg/ml) Idarubicin (1.0mg/ml) Busulfan (6.0mg/ml) Ifosfamide (50mg/ml) Carboplatin (10.0mg/ml) Irinotecan (20.0mg/ml) Cisplatin (1 mg/ml) Mechlorethamine HCl (1.0mg/ml) Cyclophosphamide (20 mg/ml) Melphalan (5.0mg/ml) Cytarabine HCl (100.0mg/ml) Methotrexate (25.0mg/ml) Dacarbazine (10 mg/ml) Mitomycin (0.5mg/ml) Daunorubicin HCl (5.0mg/ml) Mitoxantrone (2 mg/ml) Docetaxel (10.0mg/ml) Paclitaxel (Taxol) (6 mg/ml) Doxorubicin HCl (Adriamycin) (2 mg/ml) Paraplatin (10.0mg/ml) Ellence (Epirubicin) (2.0mg/ml) Rituximab (10.0mg/ml) Etoposide (20 mg/ml) ThioTEPA (10.0mg/ml) Fludarabine (25.0mg/ml) Trisenox (0.1mg/ml) Fluorouracil (adrucil) (50 mg/ml) Vincristine Sulfate (1 mg/ml) Gemcitabine (38.0mg/ml) Please note that the following drug has extremely low permeation times of less than 60 minutes: Carmustine (3.3 mg/ml) 48.6 minutes 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 drug concentrations per ASTM D6978-05: The following drugs had NO breakthrough detected up to 240 minutes: Bleomycin sulfate (15.0mg/ml) Idarubicin (1.0mg/ml) Busulfan (6.0mg/ml) Ifosfamide (50mg/ml) Carboplatin (10.0mg/ml) Irinotecan (20.0mg/ml) Cisplatin (1 mg/ml) Mechlorethamine HCl (1.0mg/ml) Cyclophosphamide (20 mg/ml) Melphalan (5.0mg/ml) Cytarabine HCl (100.0mg/ml) Methotrexate (25.0mg/ml) Dacarbazine (10 mg/ml) Mitomycin (0.5mg/ml) Daunorubicin HCl (5.0mg/ml) Mitoxantrone (2 mg/ml) Docetaxel (10.0mg/ml) Paclitaxel (Taxol) (6 mg/ml) Doxorubicin HCl (Adriamycin) (2 mg/ml) Paraplatin (10.0mg/ml) Ellence (Epirubicin) (2.0mg/ml) Rituximab (10.0mg/ml) Etoposide (20 mg/ml) ThioTEPA (10.0mg/ml) Fludarabine (25.0mg/ml) Trisenox (0.1mg/ml) Fluorouracil (adrucil) (50 mg/ml) Vincristine Sulfate (1 mg/ml) Gemcitabine (38.0mg/ml) Please note that the following drug has extremely low permeation times of less than 60 minutes: Carmustine (3.3 mg/ml) 48.6 minutes 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. 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/K102032
Methodology: https://510kreport.com/methodology