Cleared Traditional

K042567 - POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES WITH ALOE VERA AND VITAMIN E

K042567 is an FDA 510(k) clearance for POWDERFREE POLYCHLOROPRENE STERILIZED S..., manufactured by Pt. Medisafe Technologies. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K042567 · Pt. Medisafe Technologies · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
114d
Days
Class 1
Risk

K042567 is an FDA 510(k) clearance for the POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES WITH ALOE VERA AND VITA.... Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Pt. Medisafe Technologies (Medan, North Sumatra, ID). The FDA issued a Cleared decision on January 13, 2005 after a review of 114 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.

View all Pt. Medisafe Technologies devices

FDA 510(k) Submission Details - K042567

510(k) Number K042567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2004
Decision Date January 13, 2005
Days to Decision 114 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 129d · This submission: 114d
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 322
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K042567.
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
DERMA PRENE ULTRA POWDER-FREE POLYCHLOROPRENE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE)
K043508 · Ansell Healthcare Products, LLC · Jan 2005
ESTEEM BLUE POLYISOPRENE SURGICAL GLOVES WITH COATING (CONTAINING CHITOSAN, PROVITAMIN B, GLUCONOLACTONE AND GLYCEROL)
K042574 · Cardinalhealth · Dec 2004
MAXITEX LATEX NEURO PF SURGICAL GLOVE POWDERFREE
K041437 · Terang Nusa Sdn Bhd · Sep 2004
SYNTHETIC SURGICAL GLOVE-POWDERFREE NUZONE X2
K041436 · Terang Nusa Sdn Bhd · Aug 2004