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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 553
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K021065.
ELASTYLITE SYNTHETIC POWDERED SURGICAL GLOVE
K021598 · Eci Medical Technologies, Inc. · Jun 2002
LATEX SURGEONS GLOVE (POWDER FREE)
K014283 · Brightway Gloves Pvt. , Ltd. · May 2002
LATEX SURGEONS GLOVE (POWDERED)
K014278 · Brightway Gloves Pvt. , Ltd. · May 2002
ELASTYFREE SYNTHETIC POWDER-FREE SURGICAL GLOVE
K020918 · Eci Medical Technologies, Inc. · Apr 2002
REGENT BIOGEL SKINSENSE STERILE POWDER-FREE, SYNTHETIC POLYISOPRENE SURGEON'S GLOVE
K020308 · Ssl America'S, Inc. · Apr 2002
STERILE POWDER FREE LATEX SURGEON GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)
K014230 · Supermax Glove Manufacturing Sdn Bhd · Mar 2002
K021065 · PRE-POWDERED STERILE SURGEON'S GLOVES (WITH A 50 MICROGRAM/GM PROTEIN CLAIM
Download PDF Primus Gloves Private…