Cleared Traditional

K936062 - POWDER FREE LATEX EXAM GLOVES W/POLYSIL-DC24

K936062 is an FDA 510(k) clearance for POWDER FREE LATEX EXAM GLOVES W/POLYSIL..., manufactured by Hartalega Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K936062 · Hartalega Sdn Bhd · General Hospital
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Jun 1994
Decision
168d
Days
Class 1
Risk

K936062 is an FDA 510(k) clearance for the POWDER FREE LATEX EXAM GLOVES W/POLYSIL-DC24. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Hartalega Sdn Bhd (Washington, US). The FDA issued a Cleared decision on June 6, 1994 after a review of 168 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 Hartalega Sdn Bhd devices

FDA 510(k) Submission Details - K936062

510(k) Number K936062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1993
Decision Date June 06, 1994
Days to Decision 168 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
39d slower than avg
Panel avg: 129d · This submission: 168d
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 602
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K936062.
HYPOALLERGEN NON-STER POWDERFREE LATEX PAT EXAM GLOVE
K942758 · Aladan Corp. · Jul 1994
COMFIT GREEN POWDERED EXAMINATION GLOVES
K936265 · Wembley Rubber Products (M) Sdn Bhd · Jun 1994
COMFIT PINK POWDERED EXAMINATION GLOVES
K936267 · Wembley Rubber Products (M) Sdn Bhd · Jun 1994
POWDER FREE LATEX EXAM GLOVES W/POLYSIL-DC929
K936063 · Hartalega Sdn Bhd · Jun 1994
LATEX PATIENT EXAMINATION GLOVE
K940022 · Siam Sempermed Corp., Ltd. · May 1994
COMFIT POWERED EXAMINATION GLOVES(BEADED, HYPOALLERG)
K935866 · Wembley Rubber Products (M) Sdn Bhd · May 1994