Cleared Traditional

GLOVE & LATEX FINGER COTS (K772336) - FDA 510(k) Clearance

Class I General Hospital device.

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.