# K081260: Kimberly-Clark *Lavender* Nitrile Power-Free Exam Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Kimberly-Clark Corp.
- Decided: Jul 9, 2008 after 68 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: 1 generation back to K051347 (2005). 1 ancestor in all.
16 later devices descend from it; 5 cite it directly.
0 of 18 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.

## Most influential descendants
- K101596: Kimberly-Clark Purple Nitrile Powder-Free Exam Glove (Chemotherapy Glove) and Kimberly-Clark Purple Nitrile Xtra Powder- (2010), 11 descendants of its own
- K153708: Halyard Black-Orange Powder-Free Nitrile Exam Glove (2016), 5 descendants of its own
- K113423: Kimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free Exam Glove (2012), 5 descendants of its own
- K200633: Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove (2020), 4 descendants of its own
- K160709: HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves (2016), 2 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/K081260
Methodology: https://510kreport.com/methodology