# K212848: Sterile Latex Surgical Gloves Powder Free

- Pathway: 510(k) (Abbreviated)
- Applicant: Pentavest Holdings Sdn Bhd
- Decided: Dec 27, 2021 after 111 days
- Product code: KGO (Surgeon'S Gloves)
- Device class: 1
- Regulation: 21 CFR 878.4460
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K050071 (2005). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192328: JR.MEDIK Latex Surgeon’s Gloves Powder Free, Jr Engineering & Medical Technologies (M) Sdn. Bhd. (2020) Summary page 5.

## Most influential descendants
- K253060: Sterile Latex Powder Free Surgical Gloves (2026), 0 descendants of its own
- K231446: Single-Use Latex Sterile Surgical Gloves (SG100) (2023), 0 descendants of its own

## Indications for use
Sterile Latex Surgical Gloves Powder Free is a device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Source page: https://510kreport.com/device/K212848
Methodology: https://510kreport.com/methodology