# K113423: Kimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free Exam Glove

- Pathway: 510(k) (Traditional)
- Applicant: Kimberly-Clark Corp.
- Decided: Mar 9, 2012 after 109 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: 3 generations back to K051347 (2005). 9 ancestors in all.
5 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)
- K102032: Kimberly-Clark Purple Nitrile Xtra* Sterile Powder-Free Exam Glove (Chemotherapy Glove) - 12 Sterile Pairs, Kimberly-Clark Corp. (2010) Summary page 1.
- K101596: Kimberly-Clark Purple Nitrile Powder-Free Exam Glove (Chemotherapy Glove) and Kimberly-Clark Purple Nitrile Xtra Powder-, Kimberly-Clark (2010) Summary page 5.

## Most influential descendants
- 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
- K182096: Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs (2018), 0 descendants of its own
- K162294: Brightway Brand Nitrile Examination Gloves 12”, Powder Free, [Purple] Tested for Use with Chemotherapy Drugs (2017), 0 descendants of its own
- K162381: HG PRO XP Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs (2017), 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 mg/ml) Gemcitabine HCl (38.0mg/ml) Busulfan (6 mg/ml) Idarubicin HCl (1.0mg/ml) Carboplatin (10 mg/ml) Ifosfamide (50.0 mg/ml) Cisplatin (1.0 mg/ml) Irinotecan HCl (20.0 mg/ml) Cyclophosphamide (20.0 mg/ml) Mechlorethamine HCl (1.0 mg/ml) Cytarabine HCl (100 mg/ml) Melphalan (5mg/ml) Dacarbazine (10 mg/ml) Methotrexate (25 mg/ml) Daunorubicin HCl (5.0 mg/ml) Mitomycin-C (0.5 mg/ml) Docetaxel (10.0 mg/ml) Mitoxantrone (2.0 mg/ml) Doxorubicin HCl (2.0 mg/ml) Paclitaxel (6.0 mg/ml) Epirubicin (Ellence) (2mg/ml) Rituximab (10 mg/ml) Etoposide (20.0 mg/ml) ThioTEPA (10.0 mg/ml) Fludarabine (25 mg/ml) Trisenox (0.1 mg/ml) Fluorouracil (50.0 mg/ml) Vincristine Sulfate (1.0 mg/ml) Please note that the following drug has low permeation times of less than 60 minutes: Carmustine (3.3 mg/ml) 30.7 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.

Source page: https://510kreport.com/device/K113423
Methodology: https://510kreport.com/methodology