Cleared Traditional

K884030 - ERGO II, SURGICAL LATEX GLOVES

K884030 is an FDA 510(k) clearance for ERGO II, manufactured by Ergo Intl., Ent., Inc.. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K884030 · Ergo Intl., Ent., Inc. · General Hospital
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Nov 1988
Decision
45d
Days
Class 1
Risk

K884030 is an FDA 510(k) clearance for the ERGO II, SURGICAL LATEX GLOVES. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Ergo Intl., Ent., Inc. (North Miami Beach, US). The FDA issued a Cleared decision on November 7, 1988 after a review of 45 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 Ergo Intl., Ent., Inc. devices

FDA 510(k) Submission Details - K884030

510(k) Number K884030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1988
Decision Date November 07, 1988
Days to Decision 45 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
84d faster than avg
Panel avg: 129d · This submission: 45d
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 379
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K884030.
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
PTI HEART-LIFT(TM) CARDIAC RETRACTION GLOVES-STERI
K882381 · Pioneering Technologies, Inc. · Jul 1988
SAFESKIN STERILE SURGEONS GLOVES
K880446 · Safeskin Corp. · Jun 1988