Cleared Traditional

K030445 - POWDER FREE LATEX MICROSURGERY GLOVES WITH BROWN COLOR AND PROTEIN LABELING CLAIM OF 50 MICROGRAMS OR LESS PROTEIN GRAM

K030445 is an FDA 510(k) clearance for POWDER FREE LATEX MICROSURGERY GLOVES W..., manufactured by Primus Gloves Private , Ltd.. 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.

K030445 · Primus Gloves Private , Ltd. · General Hospital
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Jun 2003
Decision
114d
Days
Class 1
Risk

K030445 is an FDA 510(k) clearance for the POWDER FREE LATEX MICROSURGERY GLOVES WITH BROWN COLOR AND PROTEIN LABELING C.... Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Primus Gloves Private , Ltd. (Kakkanad, Cochin, Kerala, IN). The FDA issued a Cleared decision on June 5, 2003 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.

FDA 510(k) Submission Details - K030445

510(k) Number K030445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 2003
Decision Date June 05, 2003
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 553
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K030445.
ALOETOUCH POWDER FREE LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELING CLAIM (50
K032464 · Wrp Asia Pacific Sdn. Bhd. · Aug 2003
YA MEI FIRST AID KIT
K031130 · Ya Mei Technology Co., Ltd. · Jun 2003
PRE-POWDERED LATEX ORTHOPEDIC SURGEON'S GLOVES
K030444 · Primus Gloves Private , Ltd. · Jun 2003
POWDER-FREE RADIATION ATTENUATING NEOPRENE SURGICAL GLOVE (BLACK)
K022873 · International Biomedical, Inc. · Mar 2003
POWDERFREE POLYCHLOROPRENE STERILIZED SURGICAL GLOVES
K030228 · Pt. Medisafe Technologies · Mar 2003
POWDER FREE LATEX SURGEON'S GLOVES CONTAINS 50 MEGM OR LESS OF TOTAL WATER EXTRACTABLE PER GRAM
K023912 · Sanrea Healthcare Private Limited · Feb 2003
K030445 · POWDER FREE LATEX MICROSURGERY GLOVES WITH BROWN COLOR AND PROTEIN LABELING CLAIM OF 50 MICROGRAMS OR LESS PROTEIN GRAM
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