Cleared Traditional

K926049 - DIGITEX, DIGITEX HYPOALLERGENIC

K926049 is an FDA 510(k) clearance for DIGITEX, manufactured by Mayer Laboratories. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K926049 · Mayer Laboratories · General Hospital
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Jul 1993
Decision
233d
Days
Class 1
Risk

K926049 is an FDA 510(k) clearance for the DIGITEX, DIGITEX HYPOALLERGENIC. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Mayer Laboratories (Oakland, US). The FDA issued a Cleared decision on July 22, 1993 after a review of 233 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.

FDA 510(k) Submission Details - K926049

510(k) Number K926049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1992
Decision Date July 22, 1993
Days to Decision 233 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
104d slower than avg
Panel avg: 129d · This submission: 233d
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 1236
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K926049.
POWDERFREE NATURAL LATEX GLOVES
K921389 · Arista Latindo Industrial Ltd. P.T · Aug 1993
PATIENT EXAMINATION GLOVE
K924556 · Cenland Industries Sdn Bhd · Aug 1993
STERILE HYPOALLERGENIC POWDER-FREE LATEX SURG. GLV
K923589 · Tomarc (M) Sdn Bhd · Jul 1993
PATIENT EXAMINATION GLOVES
K924386 · Wuhrlin Soplamed (M) Sdn Bhd · Jul 1993
HYPOALLERGENIC MULTI-COMFORT EXAMINATION GLOVES
K925363 · Perusahaan Intan Emas Sdn. Bhd. · Jul 1993
POWDER FREE LATEX EXAM GLOVES
K925685 · M.M. Rubber Co. , Ltd. · Jun 1993
K926049 · DIGITEX, DIGITEX HYPOALLERGENIC
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