# K042805: Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile

- Pathway: 510(k) (Traditional)
- Applicant: Perusahaan Getah Asas Sdn. Bhd.
- Decided: Dec 16, 2004 after 65 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
No predicates in its family tree.
87 later devices descend from it; 1 cites it directly.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K081089: Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with Chemotherapy Drug Use Claim (2008), 86 descendants of its own
- K141982: Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs (2015), 67 descendants of its own
- K163146: POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs (2017), 41 descendants of its own
- K172525: Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (2017), 39 descendants of its own
- K173942: Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (2018), 17 descendants of its own

## Indications for use
A Powder Free Nitrite Patient Examination Glove is a dispoable device intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants. In addition, these gloves are worn to protect against exposure to some chemotherapy drugs.

Source page: https://510kreport.com/device/K042805
Methodology: https://510kreport.com/methodology