# K070861: Powder Free Nitrile Examination Gloves, Blue

- Pathway: 510(k) (Traditional)
- Applicant: Hong Xin Rubber Products Co., Ltd.
- Decided: May 15, 2007 after 48 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.
4 later devices descend from it; 4 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K001128: Nitrile Exam Gloves, Powder-Free, Color Blue, Shanghai Poseidon Plastic Products Co., Ltd. (2000). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K122408: Powder Free Nitrile Examination Gloves (Black, White, Green) (2013), 0 descendants of its own
- K103770: Same/Various Distributors/ WE May Private Label (2011), 0 descendants of its own
- K101594: Powder Free Nitrile Patient Examination Gloves, Blue (2010), 0 descendants of its own
- K101595: Powder Free Nitrile Patient Examination Gloves, Blue (2010), 0 descendants of its own

## Indications for use
A patient examination glove is disposable device intended for medical a purpose that is worn on the examiner's hand or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K070861
Methodology: https://510kreport.com/methodology