Cleared Traditional

K993567 - INNOVATIVE GLOVES LATEX EXAMINATION GLOVES POWDERFREE WITH PROTEIN LABELING CLAIM [50 MICROGRAMS OR LESS]

K993567 is an FDA 510(k) clearance for INNOVATIVE GLOVES LATEX EXAMINATION GLO..., manufactured by Innovative Gloves Co;, Ltd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K993567 · Innovative Gloves Co;, Ltd. · General Hospital
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Jan 2000
Decision
83d
Days
Class 1
Risk

K993567 is an FDA 510(k) clearance for the INNOVATIVE GLOVES LATEX EXAMINATION GLOVES POWDERFREE WITH PROTEIN LABELING C.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Innovative Gloves Co;, Ltd. (Hatyai, Songkhla, TH). The FDA issued a Cleared decision on January 12, 2000 after a review of 83 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 Innovative Gloves Co;, Ltd. devices

FDA 510(k) Submission Details - K993567

510(k) Number K993567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1999
Decision Date January 12, 2000
Days to Decision 83 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
46d faster than avg
Panel avg: 129d · This submission: 83d
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 406
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K993567.
HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVE (NATURAL RUBBER LATEX-NITRILE-CONSTRUCTION
K993918 · Pamitex Industries Sdn Bhd · Feb 2000
POWERED DENTAL POWDERED EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (75 MICROGRAMS OR LESS)
K994162 · Allegiance Healthcare Corp. · Feb 2000
POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) (50 MICROGRAM OR LESS)
K994082 · Besglove Medicare Sdn. Bhd. · Jan 2000
HEALTH-PLUS, SANITEX, RELIANCE, BLUE PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (100 MIC
K993621 · Pamitex Industries Sdn Bhd · Dec 1999
GREEN POWDERED LATEX EXAMINATION GLOVES
K993452 · Top Glove Sdn. Bhd. · Dec 1999
PEPPER GREEN MINT POWDERED LATEX EXAMINATION GLOVES
K993605 · Top Glove Sdn. Bhd. · Dec 1999