Cleared Traditional

K092681 - POWDERED LATEX EXAMINATION GLOVES, NON-STERILE

K092681 is an FDA 510(k) clearance for POWDERED LATEX EXAMINATION GLOVES, manufactured by Khai Hoan Joint Stock Company. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K092681 · Khai Hoan Joint Stock Company · General Hospital
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Feb 2010
Decision
175d
Days
Class 1
Risk

K092681 is an FDA 510(k) clearance for the POWDERED LATEX EXAMINATION GLOVES, NON-STERILE. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Khai Hoan Joint Stock Company (Binh Duong Province, VN). The FDA issued a Cleared decision on February 23, 2010 after a review of 175 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 Khai Hoan Joint Stock Company devices

FDA 510(k) Submission Details - K092681

510(k) Number K092681 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2009
Decision Date February 23, 2010
Days to Decision 175 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
46d slower than avg
Panel avg: 129d · This submission: 175d
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 403
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K092681.
NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) MODEL: WHITE: X-SMALL, SMALL
K100907 · Siam Sempermed Corp., Ltd. · Jul 2010
LA GLOVE BRAND COLORED LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE (PINK/ GREEN/ VIOLET)
K093193 · La Glove (M) Sdn. Bhd. · Jun 2010
PEARLSCENT BLACK TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES, COATED WITH ALOE VERA
K100211 · Shen Wei (Usa), Inc. · May 2010
LAGLOVE BRAND COLORED LATEX EXAMINATION GLOVES POWDERED, NON-STERILE (PINK/GREEN/VIOLET)
K092499 · La Glove (M) Sdn. Bhd. · Nov 2009
NUGARD, SENSIFLEX PROCEDURE EXAMINATION GLOVES
K083337 · Terang Nusa Sdn Bhd · Jan 2009
NON-STERILE, POWDERED LATEX EXAMINATION GLOVE
K081910 · Siam Sempermed Corp., Ltd. · Sep 2008