Cleared Abbreviated

Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs

K212827 · Jr Engineering & Medical Technologies (M) Sdn. Bhd. · General Hospital

Dec 2021

Decision

94d

Days

Class 1

Risk

About This 510(k) Submission

K212827 is an FDA 510(k) clearance for the Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs, a Medical Glove, Specialty (Class I — General Controls, product code LZC), submitted by Jr Engineering & Medical Technologies (M) Sdn. Bhd. (Hulu Selangor, MY). The FDA issued a Cleared decision on December 6, 2021, 94 days after receiving the submission on September 3, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number	K212827 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 03, 2021
Decision Date	December 06, 2021
Days to Decision	94 days
Submission Type	Abbreviated
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.