Cleared Traditional

K033496 - MIDAS TOUCH BLUE LATEX EXAMINATION GLOVES - POWDER FREE FOR CHEMOTHERAPY USE

K033496 is an FDA 510(k) clearance for MIDAS TOUCH BLUE LATEX EXAMINATION GLOV..., manufactured by Industrial Clothings, Ltd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K033496 · Industrial Clothings, Ltd. · General Hospital
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Mar 2004
Decision
125d
Days
Class 1
Risk

K033496 is an FDA 510(k) clearance for the MIDAS TOUCH BLUE LATEX EXAMINATION GLOVES - POWDER FREE FOR CHEMOTHERAPY USE. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Industrial Clothings, Ltd. (Toronto, CA). The FDA issued a Cleared decision on March 9, 2004 after a review of 125 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Industrial Clothings, Ltd. devices

FDA 510(k) Submission Details - K033496

510(k) Number K033496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 2003
Decision Date March 09, 2004
Days to Decision 125 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
4d faster than avg
Panel avg: 129d · This submission: 125d
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 388
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K033496.
CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES (YELLOW)
K050277 · Hartalega Sdn Bhd · Jun 2005
DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES COATED WITH ALPHA LIPOIC ACID AND VITAMIN E, AND WITH PROTEIN CONTENT
K032016 · Wrp Specialty Products Sdn. Bhd. · May 2004
DERMAGRIP-G, AND MULTIPLE CUSTOMERS TRADE NAME GREEN, ALOE VERA COATED, POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEI
K040645 · Wrp Asia Pacific Sdn. Bhd. · Apr 2004
NON-STERILE POWDER FREE GREEN LATEX PATIENT EXAM GLOVES WITH SURFACE COATING & PROTEIN LABELING CLAIM (<50UG/DM2)
K023537 · Sgmp Co., Ltd. · Nov 2003
BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDERED, STERILE), CONTAINING 150 UGM OR LESS OF WATER EXTRACTABLE PROTEIN PER
K032938 · Brightway Holdings Sdn. Bhd. · Nov 2003
BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDER FREE, STERILE) CONTAINING 50 UGM OR LESS OF WATER EXTRACTABLE PROTEIN PE
K032940 · Brightway Holdings Sdn. Bhd. · Nov 2003