Cleared Abbreviated

JR MEDIC (K222348) - FDA 510(k) Clearance

Class I General Hospital device.

K222348 · Jr Engineering & Medical Technologies (M) Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2022
Decision
85d
Days
Class 1
Risk

K222348 is an FDA 510(k) clearance for the JR MEDIC. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Jr Engineering & Medical Technologies (M) Sdn. Bhd. (Hulu Selangor, MY). The FDA issued a Cleared decision on October 27, 2022 after a review of 85 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Jr Engineering & Medical Technologies (M) Sdn. Bhd. devices

Submission Details

510(k) Number K222348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2022
Decision Date October 27, 2022
Days to Decision 85 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 129d · This submission: 85d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code LYY Latex Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex 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.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Liberty Management Group , Ltd.
Manoj Zacharias

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LYY Latex Patient Examination Glove

All 41
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K222348.
Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)
K223298 · Shandong Intco Medical Products Co, Ltd. · Feb 2023
Powder-Free Latex examination gloves
K222612 · Guangdong Kingfa Sci. & Tech.Co., Ltd. · Nov 2022
Non Sterile Powder Free Latex Examination Glove
K221667 · New Era Medicare Sdn. Bhd. · Oct 2022
Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)
K221374 · Hebei Titans Hongsen Medical Technology Co., Ltd. · Oct 2022
Single-use medical latex examination gloves (LG100)
K222693 · Fitone Latex Products Co., Ltd. Guangdong · Sep 2022
Iconic Latex Glove
K221648 · Iconic Medicare Sdn Bhd · Aug 2022