← Product Code [LZA](/productcode/LZA) · K221773

# Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With the Opioid Fentanyl Citrate, Simulated Gastric Acid, and Fentanyl In Gastric Acid (K221773)

_Onetexx Sdn Bhd · LZA · Jul 30, 2022 · General Hospital · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K221773

## Device Facts

- **Applicant:** Onetexx Sdn Bhd
- **Product Code:** [LZA](/productcode/LZA.md)
- **Decision Date:** Jul 30, 2022
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.6250
- **Device Class:** Class 1
- **Review Panel:** General Hospital

## Regulatory Identification

A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

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**Source:** [https://fda-staging.innolitics.com/device/K221773](https://fda-staging.innolitics.com/device/K221773)

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