Cleared Traditional

Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue)

K182600 · Better Care Plastic Technology Co., Ltd. · General Hospital
Nov 2018
Decision
70d
Days
Class 1
Risk

About This 510(k) Submission

K182600 is an FDA 510(k) clearance for the Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue), a Polymer Patient Examination Glove (Class I — General Controls, product code LZA), submitted by Better Care Plastic Technology Co., Ltd. (Shenze County, CN). The FDA issued a Cleared decision on November 30, 2018, 70 days after receiving the submission on September 21, 2018. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K182600 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 2018
Decision Date November 30, 2018
Days to Decision 70 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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