Cleared Traditional

K760912 - DRESSING CHANGE KIT

K760912 is an FDA 510(k) clearance for DRESSING CHANGE KIT, manufactured by American Hospital Supply Corp.. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K760912 · American Hospital Supply Corp. · General Hospital
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Dec 1976
Decision
36d
Days
Class 1
Risk

K760912 is an FDA 510(k) clearance for the DRESSING CHANGE KIT. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by American Hospital Supply Corp. (Mchenry, US). The FDA issued a Cleared decision on December 2, 1976 after a review of 36 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4460 - 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 American Hospital Supply Corp. devices

FDA 510(k) Submission Details - K760912

510(k) Number K760912 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1976
Decision Date December 02, 1976
Days to Decision 36 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
93d faster than avg
Panel avg: 129d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

KGO Device Classification - Class 1, General Controls

Product Code KGO Surgeon's Gloves
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4460
Definition A Surgeon's Glove Is A Disposable Device Made Of Natural Rubber Latex Or Synthetic Polymers That May Or May Not Bear Powder To Facilitate Donning, And It Is Intended To Be Worn On The Hands, Usually In Surgical Settings, To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.
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 - KGO Surgeon's Gloves

All 290
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K760912.
GAMMEX SURGICAL GLOVES
K802641 · Ansell, Inc. · Dec 1980
SURGIKOS NEUTRALON BR. SURGEON'S GLOVE
K800152 · Surgikos, Inc. · Feb 1980
SUBCLAVIAN TRAY
K780419 · Concord Laboratories, Inc. · Mar 1978
GLOVE, SURGEON
K760811 · Sherwood Medical Industries · Nov 1976
GLOVES, APARTICULATE SURGICAL
K760248 · Deknatel, Inc. · Aug 1976
GLOVES, STERILE LATEX SURGEON'S
K760243 · Travenol Laboratories, S.A. · Aug 1976