Cleared Traditional

Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)

K222449 · Better Care Plastic Technology Co., Ltd. · General Hospital
Aug 2022
Decision
12d
Days
Class 1
Risk

About This 510(k) Submission

K222449 is an FDA 510(k) clearance for the Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue), a Medical Glove, Specialty (Class I — General Controls, product code LZC), submitted by Better Care Plastic Technology Co., Ltd. (Shenze County, CN). The FDA issued a Cleared decision on August 27, 2022, 12 days after receiving the submission on August 15, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K222449 FDA.gov
FDA Decision Cleared SESE
Date Received August 15, 2022
Decision Date August 27, 2022
Days to Decision 12 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LZC — Medical Glove, Specialty
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6250
Definition A Disposable Medical Glove (examination Or Surgeon?s) Is A Device That May Or May Not Bear A Trace Amount Of Residual Powder And Is Intended To Be Worn On The Hand Or Finger(s) For Medical Purposes To Prevent Contamination. In Addition, These Gloves May Have Specialty Claims Such As Chemotherapy, Etc.

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