# 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

- Pathway: 510(k) (Abbreviated)
- Applicant: Beta Healthcare Products Pvt., Ltd.
- Decided: Jan 8, 2018 after 104 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: 4 generations back to K050071 (2005). 5 ancestors in all.
11 later devices descend from it; 2 cite it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151114: Medismart ( Latex Surgeon¿s Gloves powdered ) and  Medismart + (Latex Surgeon¿s Gloves Powder Free, Polymer coated with protein, St. Marys Rubbers Pvt, Ltd. (2015) Summary page 5.
- K130450: Surgtex Powdered Surgical Glove, Surgtex Powderfree Polymer Coated Surgical Glove, Purna Bina Sdn Bhd (2014) Summary page 5.

## Most influential descendants
- 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
- K190632: Latex Surgeon’s Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein (2019), 1 descendant of its own
- K253060: Sterile Latex Powder Free Surgical Gloves (2026), 0 descendants of its own

## Indications for use
A latex 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/K172942
Methodology: https://510kreport.com/methodology