Cleared Traditional

K881191 - REGAL LATEX SURGICAL GLOVES

K881191 is an FDA 510(k) clearance for REGAL LATEX SURGICAL GLOVES, manufactured by Maxcare, Inc.. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K881191 · Maxcare, Inc. · General Hospital
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Apr 1988
Decision
11d
Days
Class 1
Risk

K881191 is an FDA 510(k) clearance for the REGAL LATEX SURGICAL GLOVES. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Maxcare, Inc. (Des Moines, US). The FDA issued a Cleared decision on April 1, 1988 after a review of 11 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 Maxcare, Inc. devices

FDA 510(k) Submission Details - K881191

510(k) Number K881191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1988
Decision Date April 01, 1988
Days to Decision 11 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
118d faster than avg
Panel avg: 129d · This submission: 11d
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 K881191.
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
REGENT DISPO STERILE BIOGEL STARCH FREE SURG GLOVE
K874099 · Biopro, Inc. · Dec 1987
LATEX SURGICAL GLOVES
K864064 · Futuremed Div. of Future Impex Corp. · Oct 1986
NEUTRALON SURGICAL GLOVES
K861441 · Surgikos, Inc. · May 1986