Cleared Traditional

K941787 - LATEX EXAM GLOVES

K941787 is an FDA 510(k) clearance for LATEX EXAM GLOVES, 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 191-day FDA review.

K941787 · P.T. Irama Dinamika Latex · General Hospital
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Oct 1994
Decision
191d
Days
Class 1
Risk

K941787 is an FDA 510(k) clearance for the LATEX EXAM GLOVES. 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 October 19, 1994 after a review of 191 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 P.T. Irama Dinamika Latex devices

FDA 510(k) Submission Details - K941787

510(k) Number K941787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1994
Decision Date October 19, 1994
Days to Decision 191 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
62d slower than avg
Panel avg: 129d · This submission: 191d
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 K941787.
COMFIT
K944140 · Wembley Rubber Products (M) Sdn Bhd · Dec 1994
COMFIT EXAMINATION GLOVES, POWDER FREE, HYPOALLERGENIC
K942947 · Wembley Rubber Products (M) Sdn Bhd · Nov 1994
LATEX EXAMINATION GLOVES
K943707 · Arista Latindo Industrial Ltd. P.T · Nov 1994
COMFIT (STERILE)
K944141 · Wembley Rubber Products (M) Sdn Bhd · Oct 1994
ROYAL SHIELD PINK COLORED NON-STERILE LATEX EXAMINATION GLOVE
K943807 · Shield Gloves Manufacturer (M) Sdn Bhd · Sep 1994
ROYAL SHIELD NON-STERILE LATEX EXAM GLOVES-BUBBLE GUM
K943043 · Shield Gloves Manufacturer (M) Sdn Bhd · Sep 1994