# K051347: Kimberly-Clark* Sterling* Nitrile Powder-Free Examination Glove

- Pathway: 510(k) (Special)
- Applicant: Kimberly-Clark Corp.
- Decided: Jun 7, 2005 after 14 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
No predicates in its family tree.
93 later devices descend from it; 3 cite it directly.
0 of 94 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 its predicate without a number.
- (no number) SAFESKIN* PURPLE NITRILE* Powder-Free Exam Glove: named in the summary without a submission 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
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/K051347
Methodology: https://510kreport.com/methodology