Cleared Traditional

K993452 - GREEN POWDERED LATEX EXAMINATION GLOVES

K993452 is an FDA 510(k) clearance for GREEN POWDERED LATEX EXAMINATION GLOVES, 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 68-day FDA review.

K993452 · Top Glove Sdn. Bhd. · General Hospital
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Dec 1999
Decision
68d
Days
Class 1
Risk

K993452 is an FDA 510(k) clearance for the GREEN POWDERED LATEX EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Top Glove Sdn. Bhd. (Klang, Selangor, MY). The FDA issued a Cleared decision on December 20, 1999 after a review of 68 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 - K993452

510(k) Number K993452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1999
Decision Date December 20, 1999
Days to Decision 68 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
61d faster than avg
Panel avg: 129d · This submission: 68d
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 K993452.
POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K993529 · Biografik (Malaysia) Sdn Bhd · Dec 1999
HEALTH-PLUS, SANITEX, RELIANCE, BLUE PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (100 MIC
K993621 · Pamitex Industries Sdn Bhd · Dec 1999
LATEX EXAMINATION POWDERED GLOVES
K993386 · Great Glove Sdn Bhd · Dec 1999
PEPPER GREEN MINT POWDERED LATEX EXAMINATION GLOVES
K993605 · Top Glove Sdn. Bhd. · Dec 1999
PATIENT LATEX EXAMINATION POWDER-FREE POLYMER COATED GLOVES
K992676 · Wear Safe Malaysia Sdn. Bhd. · Dec 1999
PATIENT LATEX EXAMINATION GLOVE POWDERED & POWDER FREE, STERILE
K992681 · Wear Safe Malaysia Sdn. Bhd. · Dec 1999