# K190632: Latex Surgeon’s Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein

- Pathway: 510(k) (Abbreviated)
- Applicant: Lenora Glove Pvt, Ltd.
- Decided: Oct 24, 2019 after 226 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: 5 generations back to K050071 (2005). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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, Beta Healthcare Products Pvt., Ltd. (2018) Summary page 5.

## Most influential descendants
- K202401: Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein (2021), 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/K190632
Methodology: https://510kreport.com/methodology