Cleared Traditional

K882392 - BURNET LABORATOIRE PHARMACEUTIQUE SURGI...

K882392 is an FDA 510(k) clearance for BURNET LABORATOIRE PHARMACEUTIQUE SURGI..., manufactured by Roseburg SA. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K882392 · Roseburg SA · General Hospital
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Aug 1988
Decision
77d
Days
Class 1
Risk

K882392 is an FDA 510(k) clearance for the BURNET LABORATOIRE PHARMACEUTIQUE SURGICAL GLOVES. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Roseburg SA (Washington, US). The FDA issued a Cleared decision on August 26, 1988 after a review of 77 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 Roseburg SA devices

FDA 510(k) Submission Details - K882392

510(k) Number K882392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1988
Decision Date August 26, 1988
Days to Decision 77 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
52d faster than avg
Panel avg: 129d · This submission: 77d
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 241
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K882392.
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
SAFESKIN STERILE SURGEONS GLOVES
K880446 · Safeskin Corp. · Jun 1988
REGENT DISPO STERILE BIOGEL STARCH FREE SURG GLOVE
K874099 · Biopro, Inc. · Dec 1987
NEUTRALON SURGICAL GLOVES
K861441 · Surgikos, Inc. · May 1986