# K090412: Powder Free Nitrile Examination Gloves (Pink, Green, Orange,White).

- Pathway: 510(k) (Traditional)
- Applicant: Gx Corporation Sdn Bhd
- Decided: Jun 1, 2009 after 103 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
No predicates in its family tree.
7 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K151750: Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Powder Free Nitrile Patient Examination Glove, White Colored, Non-Sterile (2016), 4 descendants of its own
- K161215: Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs (2016), 1 descendant of its own
- K151824: Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs, Powder Free Nitrile Patient Examination Glove, White Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs (2016), 1 descendant of its own
- K183441: Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs (2019), 0 descendants of its own
- K172864: Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (2018), 0 descendants of its own

## Indications for use
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove is tested for use with Dacarbazine (DTIC), Mitomycin C, Methotrexate, Cyclophosphamide (Cytoxan), Mitoxantrone, Doxorubicin Hydrochloride, Ifosfamide (Ifex), 5-Fluorouracil, Cisplatin, Etoposide, Paclitaxel (taxol), Vincristine Sulfate Warning: Not Recommended For Use With Carmustine and Thio-Tepa

Source page: https://510kreport.com/device/K090412
Methodology: https://510kreport.com/methodology