# K171367: SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES)

- Pathway: 510(k) (Traditional)
- Applicant: Sanrea Healthcare Products Pvt, Ltd.
- Decided: Jan 26, 2018 after 262 days
- Product code: LYY (Latex 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
Longest line of descent: 1 generation back to K052728 (2005). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052728: Powder Free Latex Sterile Patient Examination Gloves, M/S. Kanam Latex Industries Pvt., Ltd. (2005) Summary page 5.

## Most influential descendants
- K223298: Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) (2023), 0 descendants of its own

## Indications for use
The Sterile Latex Patient Examination gloves, Powder Free, is a disposable device intended for medical purposes that is worn on the examiners’ hand or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K171367
Methodology: https://510kreport.com/methodology