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.

View all Tactyl Technologies, Inc. devices

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
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 16
Devices cleared under the same product code (FMC) and FDA review panel - the closest regulatory comparables to K905109.
NITRILE RUBBER POWDER-FREE EXAMINATION GLOVE
K932404 · Safeskin Corp. · May 1994
NITRILE RUBBER EXAMINATION GLOVES (POWERED)
K932405 · Safeskin Corp. · May 1994
SURGICAL INSTRUMENT KIT, DISPOSABLE
K923175 · Ulti-Med Intl., Inc. · Jun 1993
COMFIT, PATIENT EXAMINATION GLOVES
K903746 · Wembley Rubber Products (M) Sdn Bhd · Sep 1990
ROCKET SEX CRIME KIT
K883805 · A & A Medical, Inc. · Jan 1989
ORTHOPEDIC SURGICAL GLOVE
K831564 · Ansell, Inc. · Jul 1983