# K211182: H2H Powder Free Examination Blue Glove

- Pathway: 510(k) (Traditional)
- Applicant: Ntl Innovation Co., Ltd.
- Decided: Aug 1, 2021 after 103 days
- Product code: LZA (Polymer 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The H2H Powder Free Nitrile Examination Blue Gloves are disposable devices intended for medical purposes that are worn on the examiner’s hand to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K211182
Methodology: https://510kreport.com/methodology