Cleared Traditional

Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green)

K232070 · Better Care Plastic Technology Co., Ltd. · General Hospital
Oct 2023
Decision
91d
Days
Class 1
Risk

About This 510(k) Submission

K232070 is an FDA 510(k) clearance for the Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green), 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 October 11, 2023, 91 days after receiving the submission on July 12, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K232070 FDA.gov
FDA Decision Cleared SESE
Date Received July 12, 2023
Decision Date October 11, 2023
Days to Decision 91 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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