Cleared Traditional

K905109 - PATIENT EXAMINATION GLOVE/HYPOALLERGENIC

K905109 is an FDA 510(k) clearance for PATIENT EXAMINATION GLOVE/HYPOALLERGENIC, manufactured by Tactyl Technologies, Inc.. The device is a Class 1 General Hospital device with product code FMC cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K905109 · Tactyl Technologies, Inc. · General Hospital
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Nov 1990
Decision
8d
Days
Class 1
Risk

K905109 is an FDA 510(k) clearance for the PATIENT EXAMINATION GLOVE/HYPOALLERGENIC. Classified as Patient Examination Glove (product code FMC), Class I - General Controls.

Submitted by Tactyl Technologies, Inc. (Vista, US). The FDA issued a Cleared decision on November 21, 1990 after a review of 8 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K905109

510(k) Number K905109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1990
Decision Date November 21, 1990
Days to Decision 8 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 129d · This submission: 8d
Pathway characteristics
Predicate-based equivalence.

FMC Device Classification - Class 1, General Controls

Product Code FMC Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
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 - FMC Patient Examination Glove

All 23
Devices cleared under the same product code (FMC) and FDA review panel - the closest regulatory comparables to K905109.
COMPASEP
K920649 · Wilde-USA, Inc. · Jul 1992
GLASION VARNISH
K915376 · Sci-Pharm Scientific Pharmaceutical, Inc. · Jan 1992
LATEX GLOVE APPLICATION AND REMOVAL SYSTEM
K905127 · Success Builders Intl., Inc. · Jan 1991
COMFIT, PATIENT EXAMINATION GLOVES
K903746 · Wembley Rubber Products (M) Sdn Bhd · Sep 1990
PVC PATIENT EXAMINATION GLOVE
K902278 · Fujian Province Jiu Zhou Group · Aug 1990
ROCKET SEX CRIME KIT
K883805 · A & A Medical, Inc. · Jan 1989
K905109 · PATIENT EXAMINATION GLOVE/HYPOALLERGENIC
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