Cleared Traditional

K980611 - POWDERED LATEX EXAMINATION GLOVES

K980611 is an FDA 510(k) clearance for POWDERED LATEX EXAMINATION GLOVES, manufactured by Servicom Services Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K980611 · Servicom Services Sdn Bhd · General Hospital
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Apr 1998
Decision
99d
Days
Class 1
Risk

K980611 is an FDA 510(k) clearance for the POWDERED LATEX EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Servicom Services Sdn Bhd (Janan Ampang, Kuala Lumpur, MY). The FDA issued a Cleared decision on April 2, 1998 after a review of 99 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Servicom Services Sdn Bhd devices

FDA 510(k) Submission Details - K980611

510(k) Number K980611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1997
Decision Date April 02, 1998
Days to Decision 99 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 129d · This submission: 99d
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 K980611.
SAFETY POWDERFREE BLUE LATEX EXAMINATION GLOVES (POLYMER COATED)
K980941 · Besglove Medicare Sdn. Bhd. · Apr 1998
LATEX EXAMINATION GLOVE
K974660 · Ideal Quality Sdn., Bhd. · Apr 1998
POWDER-FREE LATEX EXAMINATION GLOVE
K974662 · Ideal Quality Sdn., Bhd. · Apr 1998
LATEX EXAM GLOVE, POWDER-FREE W/PROTEIN & HYPOALLERGENIC LABELING
K973664 · Evergrade Healthcare Products Sdn Bhd · Mar 1998
SMARTTEX
K974557 · Smart Glove Corp. Sdn Bhd · Mar 1998
LATEX EXAMINATION GLOVE POWDER FREE
K974870 · Smart Glove Corp. Sdn Bhd · Mar 1998