Cleared Traditional

DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL

K232538 · Wrp Asia Pacific Sdn. Bhd. · General Hospital
Nov 2023
Decision
87d
Days
Class 1
Risk

About This 510(k) Submission

K232538 is an FDA 510(k) clearance for the DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL, a Polymer Patient Examination Glove (Class I — General Controls, product code LZA), submitted by Wrp Asia Pacific Sdn. Bhd. (Sepang, MY). The FDA issued a Cleared decision on November 17, 2023, 87 days after receiving the submission on August 22, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K232538 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 2023
Decision Date November 17, 2023
Days to Decision 87 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LZA — Polymer Patient Examination Glove
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6250
Definition A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.

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