# K212597: Amazing+ Latex Examination Powder Free Gloves

- Pathway: 510(k) (Abbreviated)
- Applicant: Amazing Rubber Products Pvt, Ltd.
- Decided: May 28, 2022 after 285 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: 2 generations back to K141042 (2015). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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.

## Indications for use
Amazing+ Latex Examination Powder Free Gloves are disposable device intended for medical purpose that is worn on the examiner’s hand to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K212597
Methodology: https://510kreport.com/methodology