# K083755: Non-Sterile, Powder Free Nitrile Examination Glove, Lavender Blue Color, Polymer Coated, Texted with Chemotherapy Drugs

- Pathway: 510(k) (Abbreviated)
- Applicant: Siam Sempermed Corp., Ltd.
- Decided: Mar 5, 2009 after 78 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 K000323 (2000). 3 ancestors in all.
16 later devices descend from it; 4 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080520: Non Sterile, Powder Free Nitrile Examination Glove, Blue, Polymer Coating with Chemotherapy Claim, Siam Sempermed Corp., Ltd. (2008) Summary page 2.

## Most influential descendants
- K182241: Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs (2019), 8 descendants of its own
- K200072: KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl, Gastric acid, and Fentanyl in Gastric acid (2020), 3 descendants of its own
- K193581: Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Oyster (2020), 3 descendants of its own
- K171378: Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs (2017), 3 descendants of its own
- K223903: Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104); X-LARGE SIZE (NGPF105) (2023), 2 descendants of its own

## Indications for use
A 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. The tested chemotherapy drugs are as follows: Amethopterin Hydrate (Methotrexate), Cisplatin, Cyclophosphamide (Cytoxan), Dacarbazine (DTIC), Doxorubicin Hydrochloride, Etoposide (Toposar), 5-Fluorouracil, Paclitaxel (Taxol), and Vincristine Sulfate.

Source page: https://510kreport.com/device/K083755
Methodology: https://510kreport.com/methodology