Cleared Traditional

K974832 - POWDERFREE LATEX EXAMINATION GLOVES

K974832 is an FDA 510(k) clearance for POWDERFREE 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 49-day FDA review.

K974832 · Servicom Services Sdn Bhd · General Hospital
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Feb 1998
Decision
49d
Days
Class 1
Risk

K974832 is an FDA 510(k) clearance for the POWDERFREE 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 February 11, 1998 after a review of 49 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 Servicom Services Sdn Bhd devices

FDA 510(k) Submission Details - K974832

510(k) Number K974832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1997
Decision Date February 11, 1998
Days to Decision 49 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
80d faster than avg
Panel avg: 129d · This submission: 49d
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 K974832.
LOVYTEX SDN BHD POWDER-FREE LATEX EXAMINATION GLOVES
K980618 · Lovytex 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
LATEX (POWDER FREE) LOW PROTEIN
K974853 · P.T. Healthcare Glovindo · Feb 1998
POWDERFREE GREEN LATEX EXAMINATION GLOVES (POLYMER COATED)
K980037 · Sri Johani Sdn. Bhd. · Feb 1998
POWDERFREE GREEN LATEX EXAMINATION GLOVES
K980038 · Sri Johani Sdn. Bhd. · Feb 1998