# K014134: Powder-Free Latex Exam Gloves with Protein Labeling (<50UG/G)

- Pathway: 510(k) (Traditional)
- Applicant: Supergrade Healthcare Products Sdn. Bhd.
- Decided: Jan 22, 2002 after 36 days
- Product code: FMC (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.
3 later devices descend from it; 2 cite it directly.
0 of 4 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
- K020042: Hycare Latex Examination Glove, Powder Free (2002), 1 descendant of its own
- K211209: Hycare Med+ Nitrile Examination Gloves; Hycare Touch Latex Examination Gloves (2021), 0 descendants of its own
- K023577: Powder Free Latex Exam Gloves, Poly Coated Natural and/or Colored, with Protein Labeling (<50UN/G) (2002), 0 descendants of its own

Source page: https://510kreport.com/device/K014134
Methodology: https://510kreport.com/methodology