Cleared Traditional

K984449 - NATURAL RUBBER PRE-POWDERED COLORED & FLAVORED PATIENT EXAMINATION GLOVES WITH PROTEIN LABELLING CLAIM

K984449 is an FDA 510(k) clearance for NATURAL RUBBER PRE-POWDERED COLORED & F..., manufactured by P.T. Irama Dinamika Latex. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K984449 · P.T. Irama Dinamika Latex · General Hospital
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Mar 1999
Decision
95d
Days
Class 1
Risk

K984449 is an FDA 510(k) clearance for the NATURAL RUBBER PRE-POWDERED COLORED & FLAVORED PATIENT EXAMINATION GLOVES WIT.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by P.T. Irama Dinamika Latex (Indonesia, ID). The FDA issued a Cleared decision on March 19, 1999 after a review of 95 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 P.T. Irama Dinamika Latex devices

FDA 510(k) Submission Details - K984449

510(k) Number K984449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1998
Decision Date March 19, 1999
Days to Decision 95 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
34d faster than avg
Panel avg: 129d · This submission: 95d
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 442
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K984449.
BRIGHTWAY BRAND LATEX EXAMINATION GLOVE (LOW PROTEIN)
K990540 · Brightway Holdings Sdn. Bhd. · Apr 1999
BRIGHTWAY BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FREE)
K990543 · Brightway Holdings Sdn. Bhd. · Apr 1999
ULTRA CARE NON-STERILE POWDER FREE (GREEN) NATURAL RUBBER LATEX PATIENT EXAMINATION GLOVE
K982505 · Tillotson Healthcare Corp. · Apr 1999
LAGLOVE BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FREE)
K990268 · La Glove (M) Sdn. Bhd. · Feb 1999
LAGLOVE BRAND LATEX EXAMINATION GLOVE (POWDER FREE)
K990270 · La Glove (M) Sdn. Bhd. · Feb 1999
LAGLOVE BRAND LATEX EXAMINATION GLOVES (LOW PROTEIN)
K990285 · La Glove (M) Sdn. Bhd. · Feb 1999