Cleared Traditional

K023159 - MIDAS TOUCH BLUE LATEX EXAMINATION GLOVES - POEDER FREE

K023159 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 50-day FDA review.

K023159 · Industrial Clothings, Ltd. · General Hospital
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Nov 2002
Decision
50d
Days
Class 1
Risk

K023159 is an FDA 510(k) clearance for the MIDAS TOUCH BLUE LATEX EXAMINATION GLOVES - POEDER FREE. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Industrial Clothings, Ltd. (Colombo 14, LK). The FDA issued a Cleared decision on November 12, 2002 after a review of 50 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 Industrial Clothings, Ltd. devices

FDA 510(k) Submission Details - K023159

510(k) Number K023159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2002
Decision Date November 12, 2002
Days to Decision 50 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
79d faster than avg
Panel avg: 129d · This submission: 50d
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 K023159.
NON-STERILE, POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING, ALOE, VITAMIN E AND PROTEIN CLAIM
K024121 · Siam Sempermed Corp., Ltd. · Dec 2002
DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
K024102 · Allegiance Healthcare Corp. · Dec 2002
POWDER FREE LATEX EXAM GLOVES, POLY COATED NATURAL AND/OR COLORED, WITH PROTEIN LABELING (<50UN/G)
K023577 · Yty Industry (Manjung) Sdn Bhd · Dec 2002
POWDERED NATURAL AND/OR COLORED LATEX EXAM GLOVES
K023590 · Yty Industry (Manjung) Sdn Bhd · Nov 2002
POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELING CLAIM (200 MICROGRAM PER GRAM OF GLOVE OR LESS)
K023262 · Perusahaan Getah Asas Sdn. Bhd. · Oct 2002
LAXTEX EXAMINATION GLOVES, POWDERED CONTAINS 180 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
K022987 · Arista Latindo Industrial Ltd. P.T · Oct 2002