Cleared Traditional

K993820 - POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN LABELING CLAIM 50 MICROGRAM OR LESS

K993820 is an FDA 510(k) clearance for POWDER FREE LATEX EXAMINATION GLOVES, manufactured by Felda Rubber Corp.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K993820 · Felda Rubber Corp. · General Hospital
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Dec 1999
Decision
20d
Days
Class 1
Risk

K993820 is an FDA 510(k) clearance for the POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN LABELING CLAIM.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Felda Rubber Corp. (Kuala Lumpur, MY). The FDA issued a Cleared decision on December 2, 1999 after a review of 20 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 Felda Rubber Corp. devices

FDA 510(k) Submission Details - K993820

510(k) Number K993820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1999
Decision Date December 02, 1999
Days to Decision 20 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
109d faster than avg
Panel avg: 129d · This submission: 20d
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 582
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K993820.
QUALITY LATEX POWDERED LATEX MEDICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 170 MICROGRAM OR LESS
K993271 · Quality Latex Corp. Sdn Bhd · Dec 1999
POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) [50 MICROGRAMS OR LESS]
K993457 · Sri Johani Sdn. Bhd. · Dec 1999
POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL OF 50 MCROGRAM OR LESS)
K993500 · Besglove Medicare Sdn. Bhd. · Dec 1999
POWDERED LATEX EXAMINATION GLOVES(PROTEIN LABEL CLAIM 150 MICROGRAMS OR LESS)
K993495 · Besglove Medicare Sdn. Bhd. · Nov 1999
POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM 50 MICROGRAMS OR LESS)
K993502 · Besglove Medicare Sdn. Bhd. · Nov 1999
BLUE CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS.
K993722 · Hartalega Sdn Bhd · Nov 1999