# K113639: C2 Medical Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Amercare, Inc.
- Decided: May 8, 2012 after 151 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: 3 generations back to K000071 (2000). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110944: Powder-Free Vinyl Patient Examination Gloves, Wangda Plastic Co., Ltd. (2011) Summary page 1.

## Most influential descendants
- K173228: U-MED Powder Free Polyethylene Examination Gloves,Blue Color (2018), 1 descendant of its own
- K212699: Disposable Powder Free Polyethylene Examination Gloves (2022), 0 descendants of its own
- K133478: Powder Free Polyethylene Examination Gloves (2014), 0 descendants of its own

## Indications for use
A powder-free, non-sterile patient examination glove is a disposable device intended for medical purposes to be worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K113639
Methodology: https://510kreport.com/methodology