Cleared Traditional

K891404 - STERILE LATEX SURGEON'S GLOVES

K891404 is an FDA 510(k) clearance for STERILE LATEX SURGEON'S GLOVES, manufactured by Shinheng Corp.. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K891404 · Shinheng Corp. · General Hospital
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Oct 1989
Decision
216d
Days
Class 1
Risk

K891404 is an FDA 510(k) clearance for the STERILE LATEX SURGEON'S GLOVES. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Shinheng Corp. (Los Angeles, US). The FDA issued a Cleared decision on October 16, 1989 after a review of 216 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Shinheng Corp. devices

FDA 510(k) Submission Details - K891404

510(k) Number K891404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1989
Decision Date October 16, 1989
Days to Decision 216 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
87d slower than avg
Panel avg: 129d · This submission: 216d
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 378
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K891404.
TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE
K902380 · Baxter Healthcare Corp · Jun 1990
TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE
K897192 · Baxter Healthcare Corp · Feb 1990
POWDER-FREE/HYPO-ALLERGENIC STERILE SURGEON GLOVES
K895669 · Safeskin Corp. · Nov 1989
SAFESKIN POWDRED HYPOALLERGENIC STERIL SURG GLOVES
K894354 · Safeskin Corp. · Aug 1989
BDAC OMICRON PLUS SURGICAL GLOVES
K885271 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1989
BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVES
K882392 · Roseburg SA · Aug 1988