Cleared Traditional

K050071 - MEDISPO (POWDERED) AND MEDISPO-PF (POWDER-FREE) SURGEONS GLOVE

K050071 is an FDA 510(k) clearance for MEDISPO (POWDERED) AND MEDISPO-PF (POWD..., manufactured by H.B.M. USA Co.,Inc.. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K050071 · H.B.M. USA Co.,Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
119d
Days
Class 1
Risk

K050071 is an FDA 510(k) clearance for the MEDISPO (POWDERED) AND MEDISPO-PF (POWDER-FREE) SURGEONS GLOVE. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by H.B.M. USA Co.,Inc. (Queen'S Village, US). The FDA issued a Cleared decision on May 11, 2005 after a review of 119 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K050071

510(k) Number K050071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2005
Decision Date May 11, 2005
Days to Decision 119 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 129d · This submission: 119d
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 549
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K050071.
BIOGEL LATEX STERILE POWDER-FREE GLOVE
K050899 · Regent Medical Americas, LLC · Aug 2005
NUZONE X2A NEOPRENE - POLYISOPRENE POWDER FREE SURGICAL GLOVES POLYMER AND ALOE COATED
K051563 · Terang Nusa Sdn Bhd · Jun 2005
NUZONE X2T POLYCHLOROPRENE SYNTHETIC TAN SURGICAL GLOVE - POWDERFREE
K051094 · Terang Nusa Sdn Bhd · Jun 2005
MARINA MEDICAL FINGER PROTECTORS
K042534 · Marina Medical Instruments, Inc. · May 2005
ECLIPSE LATEX POWDER FREE STERILE SURGEON'S GLOVE
K050533 · Regent Medical Americas, LLC · Apr 2005
MEDIGLOVES STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES
K050181 · Medigloves , Ltd. · Apr 2005
K050071 · MEDISPO (POWDERED) AND MEDISPO-PF (POWDER-FREE) SURGEONS GLOVE
Download PDF FDA Summary H.B.M. USA Co.,Inc.