Cleared Traditional

K924909 - THE BODYGUARDS ULTRA POW-FREE HYPO LATEX EXAM GLOV

K924909 is an FDA 510(k) clearance for THE BODYGUARDS ULTRA POW-FREE HYPO LATE..., manufactured by T.K. Glove Products Co., Ltd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 230-day FDA review.

K924909 · T.K. Glove Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1993
Decision
230d
Days
Class 1
Risk

K924909 is an FDA 510(k) clearance for the THE BODYGUARDS ULTRA POW-FREE HYPO LATEX EXAM GLOV. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by T.K. Glove Products Co., Ltd. (Thailand, TH). The FDA issued a Cleared decision on May 17, 1993 after a review of 230 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 T.K. Glove Products Co., Ltd. devices

FDA 510(k) Submission Details - K924909

510(k) Number K924909 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1992
Decision Date May 17, 1993
Days to Decision 230 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 129d · This submission: 230d
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 713
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K924909.
POWDERFREE NATURAL LATEX GLOVES
K921389 · Arista Latindo Industrial Ltd. P.T · Aug 1993
DIGITEX, DIGITEX HYPOALLERGENIC
K926049 · Mayer Laboratories · Jul 1993
NON-STERILE LATEX EXAMINATION GLOVES(PRE-POWDERED)
K925683 · Arista Latindo Industrial Ltd. P.T · Jun 1993
SOLACE POWDER FREE LATEX EXAMINATION GLOVES
K922551 · Wembley Rubber Products (M) Sdn Bhd · May 1993
ANSELL NO POWDER AMBI PATIENT EXAMINATION GLOVES
K913766 · Ansell, Inc. · Mar 1993
LATEX PATIENT EXAMINATION GLOVE (POWDER FREE)
K923862 · Siam Sempermed Corp., Ltd. · Feb 1993