# K213775: Glovatex™ White Latex Gloves, Glovanil™  Blue Nitrile Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Avecena Gloves Sdn Bhd
- Decided: Apr 24, 2022 after 143 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: 4 generations back to K100603 (2010). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192329: Blue Latex Examination Powder Free Gloves, Jr Engineering & Medical Technologies (M) Sdn. Bhd. (2019) Summary page 4.
- K200326: Powder Free Nitrile Examination Glove (Aqua Green), Riverstone Resources Sdn Bhd (2020) Summary page 4.

## Indications for use
The Glovatex™ White Latex Glove is a disposable device intended for Medical purpose that is worn on the examiner’s hands or finger to prevent contamination patient and examiner. The Glovanil™ Blue Nitrile Glove is a disposable device intended for Medical purpose that is worn on the examiner’s hands or finger to prevent contamination patient and examiner.

Source page: https://510kreport.com/device/K213775
Methodology: https://510kreport.com/methodology