Cleared Traditional

K955341 - NIL LATEX POWDERFREE EXAMINATION GLOVES

K955341 is an FDA 510(k) clearance for NIL LATEX POWDERFREE EXAMINATION GLOVES, manufactured by Shangrila Latex Industries Pvt. , Ltd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K955341 · Shangrila Latex Industries Pvt. , Ltd. · General Hospital
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Optimized for regulatory review, auditing and printing
Apr 1996
Decision
157d
Days
Class 1
Risk

K955341 is an FDA 510(k) clearance for the NIL LATEX POWDERFREE EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Shangrila Latex Industries Pvt. , Ltd. (Bombay 400 026, IN). The FDA issued a Cleared decision on April 26, 1996 after a review of 157 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 Shangrila Latex Industries Pvt. , Ltd. devices

FDA 510(k) Submission Details - K955341

510(k) Number K955341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1995
Decision Date April 26, 1996
Days to Decision 157 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
28d slower than avg
Panel avg: 129d · This submission: 157d
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 582
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K955341.
POWDER FREE LATEX EXAMINATION GLOVE
K960467 · Biopro, Inc. · May 1996
PROTECTIVE LATEX POWDERED GLOVES
K960277 · Highactive Sdn. Bhd. · May 1996
POLYMER COATED CHLORINATED POWDER-FREE LATEX EXAMINATION GLOVES
K954221 · Hartalega Sdn Bhd · May 1996
PREPOWDERED LATEX EXAMINATION GLOVES
K955888 · Pantai Utama Sdn. Bhd. · Apr 1996
POWDERFREE LATEX EXAMINATION GLOVES
K955889 · Pantai Utama Sdn. Bhd. · Apr 1996
GUTHRIE POWDERFREE LATEX EXAMINATION GLOVES
K954967 · Guthrie Medicare Products (Melaka) Sdn Bhd · Apr 1996