# K081027: Kimberly-Clark Sterling Nitrile Powder-Free Exam Glove (Sterile)

- Pathway: 510(k) (Abbreviated)
- Applicant: Kimberly-Clark Corp.
- Decided: Jun 30, 2008 after 81 days
- Product code: LZA (Polymer Patient Examination Glove)
- Device class: 1
- Regulation: 21 CFR 880.6250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K992062 (1999). 2 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 12 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.
- K992062: Safeskin Sterile Purple Nitrile Examination Gloves, Safeskin Corp. (1999) Summary page 1.

## Most influential descendants
- K102032: Kimberly-Clark Purple Nitrile Xtra* Sterile Powder-Free Exam Glove (Chemotherapy Glove) - 12 Sterile Pairs (2010), 8 descendants of its own
- K113423: Kimberly Clark Purple Nitrile, and Purple Nitrile Xtra Powder Free Exam Glove (2012), 5 descendants of its own
- K160709: HALYARD* PURPLE NITRILE – XTRA* Powder-Free Exam Gloves (2016), 2 descendants of its own
- K243604: Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid (2025), 0 descendants of its own
- K243172: Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs; Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Singles (2025), 0 descendants of its own

## Recalls of this device
- Nov 10, 2016 · Class II · Z-0758-2017: Defects: Product may be discolored and brittle resulting in the inability of the user to don the gloves without tearing.

## 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/K081027
Methodology: https://510kreport.com/methodology