# K081089: Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with Chemotherapy Drug Use Claim

- Pathway: 510(k) (Traditional)
- Applicant: Kimberly-Clark Corp.
- Decided: Jul 14, 2008 after 89 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
Longest line of descent: 1 generation back to K042805 (2004). 2 ancestors in all.
86 later devices descend from it; 5 cite it directly.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051347: Kimberly-Clark* Sterling* Nitrile Powder-Free Examination Glove, Kimberly-Clark Corp. (2005) Summary page 1.
- K042805: Powder Free Nitrile Patient Examination Gloves, Blue Colored Non-Sterile, Perusahaan Getah Asas Sdn. Bhd. (2004) Summary page 1.

## Most influential descendants
- 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
- K182600: Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) (2018), 13 descendants of its own

## Indications for use
Based upon 21CFR§880.6250 "Patient examination glove" A patient examination glove is a medical device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K081089
Methodology: https://510kreport.com/methodology