Cleared Traditional

K981133 - POWDERED NITRILE EXAMINATION GLOVES

K981133 is an FDA 510(k) clearance for POWDERED NITRILE EXAMINATION GLOVES, manufactured by Servicom Services Sdn Bhd. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K981133 · Servicom Services Sdn Bhd · General Hospital
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Jun 1998
Decision
77d
Days
Class 1
Risk

K981133 is an FDA 510(k) clearance for the POWDERED NITRILE EXAMINATION GLOVES. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Servicom Services Sdn Bhd (Janan Ampang, Kuala Lumpur, MY). The FDA issued a Cleared decision on June 5, 1998 after a review of 77 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 - K981133

510(k) Number K981133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1998
Decision Date June 05, 1998
Days to Decision 77 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
52d faster than avg
Panel avg: 129d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

LZA Device Classification - Class 1, General Controls

Product Code LZA Polymer Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers 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 - LZA Polymer Patient Examination Glove

All 806
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K981133.
SUPERGLOVES POWDERED NITRILE
K980966 · Supermax Sdn Bhd · Jul 1998
NITRILON CORRECT-TOUCH
K981304 · Ct Intl. · Jun 1998
NITRILON CORRECT-TOUCH
K981333 · Biopro (M) Sdn Bhd · Jun 1998
PROFLEX POWDER FREE NITRILE EXAMINATION GLOVES
K981159 · Latexx Partners Bhd. · Jun 1998
SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES
K981349 · Smart Glove Corp. Sdn Bhd · May 1998
LOVYTEX POWDER-FREE NITRILE EXAMINATION GLOVES
K981179 · Lovytex Sdn Bhd · May 1998