Cleared Traditional

Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)

K172442 · Hartalega NGC Sdn. Bhd. · General Hospital
Nov 2017
Decision
87d
Days
Class 1
Risk

About This 510(k) Submission

K172442 is an FDA 510(k) clearance for the Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue), a Polymer Patient Examination Glove (Class I — General Controls, product code LZA), submitted by Hartalega NGC Sdn. Bhd. (Sepang, MY). The FDA issued a Cleared decision on November 6, 2017, 87 days after receiving the submission on August 11, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K172442 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 2017
Decision Date November 06, 2017
Days to Decision 87 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

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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