Cleared Traditional

K955947 - OSTAR EXAMINATION GLOVES

K955947 is an FDA 510(k) clearance for OSTAR EXAMINATION GLOVES, manufactured by Contract Latex Dippers Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K955947 · Contract Latex Dippers Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
195d
Days
Class 1
Risk

K955947 is an FDA 510(k) clearance for the OSTAR EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Contract Latex Dippers Sdn Bhd (Kuala Lumpur, MY). The FDA issued a Cleared decision on June 10, 1996 after a review of 195 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 Contract Latex Dippers Sdn Bhd devices

FDA 510(k) Submission Details - K955947

510(k) Number K955947 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1995
Decision Date June 10, 1996
Days to Decision 195 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 129d · This submission: 195d
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 K955947.
SINOCHEM NINGBO LATEX EXAMINATION GLOVE, POWDER FREE
K955918 · Sinochem Ningbo Imp & Exp Corp. · Jun 1996
HANDSAFE
K960386 · Handsafe Products Sdn. Bhd. · Jun 1996
OSTAR
K955424 · Ultravena Industries, Ltd. · Jun 1996
GLOVE SEAL & SET-RITE
K954063 · Contract Latex Dippers Sdn Bhd · Jun 1996
HIGH RISK GLOVES
K955241 · Pan-Century Rubber Products Sdn. Bhd. · May 1996
POWDER FREE LATEX EXAMINATION GLOVE
K960467 · Biopro, Inc. · May 1996