Cleared Traditional

K000142 - MIDAS TOUCH LATEX EXAMINATION GLOVES-POWDER FREE

K000142 is an FDA 510(k) clearance for MIDAS TOUCH LATEX EXAMINATION GLOVES-PO..., 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 239-day FDA review.

K000142 · Industrial Clothings, Ltd. · General Hospital
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Sep 2000
Decision
239d
Days
Class 1
Risk

K000142 is an FDA 510(k) clearance for the MIDAS TOUCH LATEX EXAMINATION GLOVES-POWDER FREE. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Industrial Clothings, Ltd. (Columbo 14, LK). The FDA issued a Cleared decision on September 13, 2000 after a review of 239 days - an extended review 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: 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.

FDA 510(k) Submission Details - K000142

510(k) Number K000142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2000
Decision Date September 13, 2000
Days to Decision 239 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
110d slower than avg
Panel avg: 129d · This submission: 239d
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 1125
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K000142.
POLYMER COAT, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K002568 · Smart Glove Corp. Sdn Bhd · Oct 2000
POWDER FREE LATEX EXAMINATION PATIENT GLOVES
K994420 · Purna Bina Sdn Bhd · Sep 2000
MIDAS TOUCH LATEX EXAMINATION GLOVES-POWDERED
K000141 · Industrial Clothings, Ltd. · Sep 2000
BESTEX POWDER-FREE LATEX EXAM GLOVES WITH LABELING CLAIM. (50 MICROGRAMS OR LESS)
K002087 · Qingdao Bestex Rubber & Plastic Products Co., Ltd. · Sep 2000
POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN LABELING CLAIM. (50 MICROGRAMS OR LESS)
K002701 · Alliance Rubber Products Sdn. Bhd. · Sep 2000
LATEX EXAMINATION GLOVES, POWDERED, (CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM).
K002448 · Oon Corp. Resources · Sep 2000