Cleared Traditional

K781820 - GLOVES

K781820 is the FDA 510(k) clearance for GLOVES by Phoenix Glove Co.. It is a Class 1 General Hospital device (product code FMC) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K781820 · Phoenix Glove Co. · General Hospital
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Dec 1978
Decision
41d
Days
Class 1
Risk

K781820 is an FDA 510(k) clearance for the GLOVES, VINYL EXAMINATION. Classified as Patient Examination Glove (product code FMC), Class I - General Controls.

Submitted by Phoenix Glove Co. (Mchenry, US). The FDA issued a Cleared decision on December 7, 1978 after a review of 41 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 Phoenix Glove Co. devices

Submission Details

510(k) Number K781820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1978
Decision Date December 07, 1978
Days to Decision 41 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
88d faster than avg
Panel avg: 129d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 10
Devices cleared under the same product code (FMC) and FDA review panel - the closest regulatory comparables to K781820.
EMBOSSED DISP. POLY. GLOVES #5101-03
K801997 · Pollak (Intl.), Ltd. · Sep 1980
STERILE EXAMINATION GLOVE #5121-5126
K801998 · Pollak (Intl.), Ltd. · Sep 1980
CONPHAR EXAM. GLOVES, POLYETHYLENE
K791805 · Conphar, Inc. · Oct 1979
CATHETEO CARE TRAY #0242
K771673 · Concord Laboratories, Inc. · Sep 1977
LACERATION KIT
K770479 · American Hospital Supply Corp. · Apr 1977