Cleared Traditional

K974356 - SURGEON'S GLOVES

K974356 is an FDA 510(k) clearance for SURGEON'S GLOVES, manufactured by American Health Products, Inc.. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K974356 · American Health Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1998
Decision
71d
Days
Class 1
Risk

K974356 is an FDA 510(k) clearance for the SURGEON'S GLOVES. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by American Health Products, Inc. (Torrance, US). The FDA issued a Cleared decision on January 29, 1998 after a review of 71 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 Health Products, Inc. devices

FDA 510(k) Submission Details - K974356

510(k) Number K974356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1997
Decision Date January 29, 1998
Days to Decision 71 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 129d · This submission: 71d
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 261
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K974356.
ELITE MARK IV POWDER FREE POLYURETHANE SYNTHETIC SURGICAL GLOVE
K981392 · Ansell Perry · May 1998
MEDI-GRIP (BEIGE 43)SURGICAL GLOVES
K980564 · Ansell Perry · Mar 1998
ENCORE MARK IV POWDER FREE SURGICAL GLOVES
K974783 · Ansell Perry · Feb 1998
ULTRALON POWDER FREE LATEX SURGICAL GLOVE
K973699 · Johnson & Johnson Medical, Inc. · Dec 1997
ELITE POWDER FREE POLYURETHANE SYNTHETIC SURGICAL GLOVE
K973461 · Ansell Perry · Dec 1997
PROFEEL POWDER FREE SURGICAL GLOVES (PROTEIN CONTENT LABELING)
K972621 · Wembley Rubber Products (M) Sdn Bhd · Oct 1997