Cleared Traditional

K772336 - GLOVE & LATEX FINGER COTS

K772336 is the FDA 510(k) clearance for GLOVE & LATEX FINGER COTS by Jamar Health Products. It is a Class 1 General Hospital device (product code FMC) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K772336 · Jamar Health Products · General Hospital
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Jan 1978
Decision
38d
Days
Class 1
Risk

K772336 is an FDA 510(k) clearance for the GLOVE & LATEX FINGER COTS. Classified as Patient Examination Glove (product code FMC), Class I - General Controls.

Submitted by Jamar Health Products (Walker, US). The FDA issued a Cleared decision on January 26, 1978 after a review of 38 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 Jamar Health Products devices

Submission Details

510(k) Number K772336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 1977
Decision Date January 26, 1978
Days to Decision 38 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
91d faster than avg
Panel avg: 129d · This submission: 38d
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 K772336.
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