# K130450: Surgtex Powdered Surgical Glove, Surgtex Powderfree Polymer Coated Surgical Glove

- Pathway: 510(k) (Traditional)
- Applicant: Purna Bina Sdn Bhd
- Decided: Sep 30, 2014 after 585 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
No predicates in its family tree.
13 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K151114: Medismart ( Latex Surgeon¿s Gloves powdered ) and  Medismart + (Latex Surgeon¿s Gloves Powder Free, Polymer coated with protein (2015), 12 descendants of its own
- K172942: Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein (2018), 11 descendants of its own
- K192328: JR.MEDIK Latex Surgeon’s Gloves Powder Free (2020), 8 descendants of its own
- K212848: Sterile Latex Surgical Gloves Powder Free (2021), 2 descendants of its own
- K212596: Sterile Latex Surgical Gloves Powder Free (2022), 1 descendant of its own

## Indications for use
This Surgeon's glove 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/K130450
Methodology: https://510kreport.com/methodology