Cleared Traditional

K991415 - SUPERGLOVES, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES

K991415 is an FDA 510(k) clearance for SUPERGLOVES, manufactured by Supermax Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K991415 · Supermax Sdn Bhd · General Hospital
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May 1999
Decision
33d
Days
Class 1
Risk

K991415 is an FDA 510(k) clearance for the SUPERGLOVES, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Supermax Sdn Bhd (Sungai Pelong, Selangor, MY). The FDA issued a Cleared decision on May 26, 1999 after a review of 33 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 Supermax Sdn Bhd devices

FDA 510(k) Submission Details - K991415

510(k) Number K991415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1999
Decision Date May 26, 1999
Days to Decision 33 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 129d · This submission: 33d
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 487
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K991415.
NON-STERILE, POWDER FREE, POLYMER COATED LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN CLAIM OF 50 MICROGRAM O
K991742 · Yty Industry (Manjung) Sdn Bhd · Jun 1999
LATEX EXAMINATION GLOVES, POWDER FREE WITH PROTEIN LABELING CLAIM (50 MCG OR LESS)
K991686 · Arista Latindo Industrial Ltd. P.T · Jun 1999
SENSIFLEX POWDERFREE LATEX EXAMINATION GLOVE
K990488 · Terang Nusa Sdn Bhd · May 1999
POLYMER COATED POWDERFREE LATEX EXAMINTATION GLOVES
K990690 · Top Glove Sdn. Bhd. · May 1999
LATEX EXAMINATION GLOVES (POWDERED)
K984229 · Sama Kejuruteraan Sdn.Bhd. · May 1999
LATEX EXAMINATION GLOVE W/ LOW PROTEIN LABELING
K990468 · Top Glove Sdn. Bhd. · Apr 1999