Cleared Traditional

K953462 - PATIENT EXAMINATION GLOVES

K953462 is an FDA 510(k) clearance for PATIENT EXAMINATION 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 164-day FDA review.

K953462 · P.T. Irama Dinamika Latex · General Hospital
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Jan 1996
Decision
164d
Days
Class 1
Risk

K953462 is an FDA 510(k) clearance for the PATIENT EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by P.T. Irama Dinamika Latex (Medan, ID). The FDA issued a Cleared decision on January 4, 1996 after a review of 164 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 - K953462

510(k) Number K953462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1995
Decision Date January 04, 1996
Days to Decision 164 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
35d slower than avg
Panel avg: 129d · This submission: 164d
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 K953462.
POLYMER COATED CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES
K954221 · Hartalega Sdn Bhd · May 1996
PATIENT EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM
K954415 · Hartalega Sdn Bhd · Mar 1996
POWDER-FREE LATES EXAM GLOVES WITH PROTEIN CLAIM
K955029 · Shen Wei (Usa), Inc. · Jan 1996
POWDER FREE PLUS PATIENT EXAMINATION GLOVE
K954855 · Tillotson Healthcare Corp. · Dec 1995
POWDER FREE LATEX EXAMINATION GLOVES
K954365 · Perusahaan Getah Asas Sdn. Bhd. · Dec 1995
LATEX PATIENT EXAMINATION GLOVE (POWDERFREE/HYPOALLERGENIC) (MODIFICATION)
K954880 · Siam Sempermed Corp., Ltd. · Nov 1995