# K002064: Comfit Chemo Plus Powder Free Blue Nitrile Examination Gloves, Non Sterile (Tested for Use with Chemotherapy Drug) Label

- Pathway: 510(k) (Traditional)
- Applicant: Wrp Asia Pacific Sdn. Bhd.
- Decided: Nov 28, 2000 after 144 days
- Product code: LZA (Polymer Patient Examination Glove)
- Device class: 1
- Regulation: 21 CFR 880.6250
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K083408: Powder Free Nitrile Patient Examination Gloves, Tested for Use with  Chemotherapy Drugs (2009), 0 descendants of its own

## Recalls of this device
- Jan 7, 2021 · Class II · Z-1079-2021: Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.
- Jan 7, 2021 · Class II · Z-1081-2021: Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.
- Jan 7, 2021 · Class II · Z-1078-2021: Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.
- Mar 22, 2019 · Class II · Z-1286-2019: Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap
- Mar 22, 2019 · Class II · Z-1284-2019: Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap
- Mar 22, 2019 · Class II · Z-1285-2019: Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap
- Mar 22, 2019 · Class II · Z-1283-2019: Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap

Source page: https://510kreport.com/device/K002064
Methodology: https://510kreport.com/methodology