Cleared Abbreviated

JR Medic

K221157 · Jr Engineering & Medical Technologies (M) Sdn. Bhd. · General Hospital
Aug 2022
Decision
131d
Days
Class 1
Risk

About This 510(k) Submission

K221157 is an FDA 510(k) clearance for the JR Medic, 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 August 30, 2022, 131 days after receiving the submission on April 21, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K221157 FDA.gov
FDA Decision Cleared SESE
Date Received April 21, 2022
Decision Date August 30, 2022
Days to Decision 131 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.

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