Cleared Traditional

K990690 - POLYMER COATED POWDERFREE LATEX EXAMINTATION GLOVES

K990690 is an FDA 510(k) clearance for POLYMER COATED POWDERFREE LATEX EXAMINT..., manufactured by Top Glove Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K990690 · Top Glove Sdn. Bhd. · General Hospital
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May 1999
Decision
78d
Days
Class 1
Risk

K990690 is an FDA 510(k) clearance for the POLYMER COATED POWDERFREE LATEX EXAMINTATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Top Glove Sdn. Bhd. (Darul Ehsan, MY). The FDA issued a Cleared decision on May 20, 1999 after a review of 78 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 Top Glove Sdn. Bhd. devices

FDA 510(k) Submission Details - K990690

510(k) Number K990690 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1999
Decision Date May 20, 1999
Days to Decision 78 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
51d faster than avg
Panel avg: 129d · This submission: 78d
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 671
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K990690.
LATEX EXAMINATION GLOVES- POWDER FREE, SIZES EXTRA SMALL, SMALL,MEDIUM,LARGE,EXTRA LARGE
K991158 · P. T. Tata Rubberindo Industries · May 1999
QTEXX POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED
K991462 · Latexx Partners Bhd. · May 1999
SUPERGLOVES, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES
K991415 · Supermax Sdn Bhd · May 1999
LATEX EXAMINATION GLOVES (POWDERED)
K984229 · Sama Kejuruteraan Sdn.Bhd. · May 1999
PRE POWDERED LATEX EXAMINATION GLOVES
K990879 · Apl Products Sdn. Bhd. · May 1999
POWDER FREE LATEX EXAMINATION GLOVES
K990686 · Tower Rubber Industries Sdn. Bhd. · May 1999