Cleared Traditional

K890344 - GLOVES

K890344 is an FDA 510(k) clearance for GLOVES, manufactured by Tomarc (M) Sdn Bhd. The device is a Class 2 Microbiology device with product code JTN cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K890344 · Tomarc (M) Sdn Bhd · Microbiology device
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Apr 1989
Decision
93d
Days
Class 2
Risk

K890344 is an FDA 510(k) clearance for the GLOVES, PATIENT EXAMINATION. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by Tomarc (M) Sdn Bhd (Kuala Lumpar, MY). The FDA issued a Cleared decision on April 26, 1989 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1620 - the FDA microbiology 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 Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Tomarc (M) Sdn Bhd devices

FDA 510(k) Submission Details - K890344

510(k) Number K890344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1989
Decision Date April 26, 1989
Days to Decision 93 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 102d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JTN Device Classification - Class 2, Special Controls

Product Code JTN Susceptibility Test Discs, Antimicrobial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1620
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - JTN Susceptibility Test Discs, Antimicrobial

All 314
Devices cleared under the same product code (JTN) and FDA review panel - the closest regulatory comparables to K890344.
IFA SENSIBAC TOBRAMYCIN
K892729 · Investigacion Farmaceutica S.A. DE C.V. · Aug 1989
IFA SENSIBAC CHLROAMPHENICOL
K892730 · Investigacion Farmaceutica S.A. DE C.V. · Aug 1989
CEFIXIME, 5 MCG SENSI-DISC ANTIMIC SUSCEP TEST DIS
K893754 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1989
AMPICILLIN/SULBACTAM 10/10 MCG SUSCEPTIBILITY DISK
K874256 · Organon Teknika Corp. · Nov 1987
CIPROFLOXACIN 5 MCG SENSI-DISC
K874425 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1987
CIPROFLOXACIN 5 MCG SUSCEPTIBILITY DISK
K873707 · Organon Teknika Corp. · Oct 1987