Cleared Traditional

K945506 - ACRYLIC DIPPED LATEX EXAMINATION GLOVES

K945506 is an FDA 510(k) clearance for ACRYLIC DIPPED LATEX EXAMINATION GLOVES, manufactured by Ganz Industries Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 337-day FDA review.

K945506 · Ganz Industries Sdn. Bhd. · General Hospital
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Oct 1995
Decision
337d
Days
Class 1
Risk

K945506 is an FDA 510(k) clearance for the ACRYLIC DIPPED LATEX EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Ganz Industries Sdn. Bhd. (Nilai 71800, Negeri Sembilan, MY). The FDA issued a Cleared decision on October 12, 1995 after a review of 337 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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.

FDA 510(k) Submission Details - K945506

510(k) Number K945506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1994
Decision Date October 12, 1995
Days to Decision 337 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
208d slower than avg
Panel avg: 129d · This submission: 337d
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 1363
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K945506.
DERRICK SAFETOUCH
K953709 · M.P.S. Pharm'L Int'L · Nov 1995
PATIENT EXAMINATION GLOVES (NON-CHLORINATED POWDER FREE, NON-STERILE)
K954081 · Tan Chong Rubber Gloves Sdn Bhd · Oct 1995
POWDERFREE LATEX GLOVE
K953986 · Steriltx · Oct 1995
POWDER-FREE LATEX EXAMINATION GLOVE
K952473 · M.M.R. Gloves Private , Ltd. · Oct 1995
ROYAL SHIELD NON-STERILE LATEX EXAMINATION GLOVES
K952588 · Shield Gloves Manufacturer Sdn. Bhd. C/O Lenty, Inc. · Oct 1995
FOR MED HIGH RISK
K953740 · For Med, Inc. · Oct 1995
K945506 · ACRYLIC DIPPED LATEX EXAMINATION GLOVES
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