Cleared Traditional

K980618 - LOVYTEX SDN BHD POWDER-FREE LATEX EXAMINATION GLOVES

K980618 is an FDA 510(k) clearance for LOVYTEX SDN BHD POWDER-FREE LATEX EXAMI..., manufactured by Lovytex Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K980618 · Lovytex Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1998
Decision
23d
Days
Class 1
Risk

K980618 is an FDA 510(k) clearance for the LOVYTEX SDN BHD POWDER-FREE LATEX EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Lovytex Sdn Bhd (Selangor, MY). The FDA issued a Cleared decision on March 13, 1998 after a review of 23 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lovytex Sdn Bhd devices

FDA 510(k) Submission Details - K980618

510(k) Number K980618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1998
Decision Date March 13, 1998
Days to Decision 23 days
Submission Type Traditional
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
106d faster than avg
Panel avg: 129d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

LYY Device Classification - Class 1, General Controls

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 Peers - LYY Latex Patient Examination Glove

All 486
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K980618.
POWDERFREE LATEX EXAMINATION GLOVES
K980194 · Besglove Medicare Sdn. Bhd. · Mar 1998
LATEX EXAMINATION GLOVES
K980215 · P.T. Wantong Industry · Mar 1998
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (GREEN)
K980572 · Hartalega Sdn Bhd · Mar 1998
POWDER-FREE LATEX EXAMINATION GLOVES (BLUE)
K980318 · Hartalega Sdn Bhd · Mar 1998
LOW PROTEIN POWDER FREE LATEX EXAMINATION GLOVES
K974782 · Mexpo Intl., Inc. · Feb 1998
POWDERFREE LATEX EXAMINATION GLOVES
K974832 · Servicom Services Sdn Bhd · Feb 1998