Cleared Traditional

K982114 - LOPRO SILICONISED LOW PROTEIN POWDERFREE LATEX EXAMINATION GLOVES

K982114 is an FDA 510(k) clearance for LOPRO SILICONISED LOW PROTEIN POWDERFRE..., manufactured by M/S Midland Latex Products , Ltd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K982114 · M/S Midland Latex Products , Ltd. · General Hospital
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Jan 1999
Decision
219d
Days
Class 1
Risk

K982114 is an FDA 510(k) clearance for the LOPRO SILICONISED LOW PROTEIN POWDERFREE LATEX EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by M/S Midland Latex Products , Ltd. (Eagan, US). The FDA issued a Cleared decision on January 21, 1999 after a review of 219 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.

View all M/S Midland Latex Products , Ltd. devices

FDA 510(k) Submission Details - K982114

510(k) Number K982114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1998
Decision Date January 21, 1999
Days to Decision 219 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
90d slower than avg
Panel avg: 129d · This submission: 219d
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 486
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K982114.
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