Cleared Traditional

K021065 - PRE-POWDERED STERILE SURGEON'S GLOVES (WITH A 50 MICROGRAM/GM PROTEIN CLAIM

K021065 is an FDA 510(k) clearance for PRE-POWDERED STERILE SURGEON'S GLOVES (..., 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 36-day FDA review.

K021065 · Primus Gloves Private , Ltd. · General Hospital
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May 2002
Decision
36d
Days
Class 1
Risk

K021065 is an FDA 510(k) clearance for the PRE-POWDERED STERILE SURGEON'S GLOVES (WITH A 50 MICROGRAM/GM PROTEIN CLAIM. 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 May 8, 2002 after a review of 36 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 Primus Gloves Private , Ltd. devices

FDA 510(k) Submission Details - K021065

510(k) Number K021065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2002
Decision Date May 08, 2002
Days to Decision 36 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 129d · This submission: 36d
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 336
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K021065.
PROFEEL POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM)
K021784 · Wrp Asia Pacific Sdn. Bhd. · Jul 2002
POWDERED BROWN LATEX SURGICAL GLOVES, STERILE WITH EXPIRATION DATE LABELING CLAIM & PROTEIN CONTENT LABELING CLAIM
K021119 · Wrp Asia Pacific Sdn. Bhd. · Jul 2002
POWDERED LATEX SURGIACAL GLOVES, STEERILE WITH EXPIRATION DATE LABELING CLAIM
K021159 · Wrp Asia Pacific Sdn. Bhd. · Jul 2002
DERMGRIP POWDER FREE POLYMER COATED LATEX SURGEON'S GLOVES,STERILE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM ORS
K014288 · Wrp Specialty Products Sdn. Bhd. · Feb 2002
POWDER FREE POLYMER COATED LATEX SURGICAL GLOVES, STERILE (PROTEIN LABELING CLAIM)
K020019 · Wrp Asia Pacific Sdn. Bhd. · Jan 2002
DURAPRENE STERILE SYNTHETIC POWDER-FREE SURGICAL GLOVES WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM
K013302 · Allegiance Healthcare Corp. · Dec 2001