Cleared Abbreviated

K062797 - POWDERED LATEX SURGICAL GLOVE

K062797 is an FDA 510(k) clearance for POWDERED LATEX SURGICAL GLOVE, manufactured by Beijing Reagent Latex Products Co., Ltd.. The device is a Class 1 General Hospital device with product code KGO cleared through the Abbreviated 510(k) pathway after a 204-day FDA review.

K062797 · Beijing Reagent Latex Products Co., Ltd. · General Hospital
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Apr 2007
Decision
204d
Days
Class 1
Risk

K062797 is an FDA 510(k) clearance for the POWDERED LATEX SURGICAL GLOVE. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Beijing Reagent Latex Products Co., Ltd. (Crofton, US). The FDA issued a Cleared decision on April 11, 2007 after a review of 204 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4460 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Beijing Reagent Latex Products Co., Ltd. devices

FDA 510(k) Submission Details - K062797

510(k) Number K062797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2006
Decision Date April 11, 2007
Days to Decision 204 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 129d · This submission: 204d
Pathway characteristics
Standards-based clearance path.

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 258
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K062797.
POWDER FREE POLYMER COATED BROWN LATEX SURGICAL GLOVES, STERILE, COATED WITH ALOE VERA AND WITH PROTEIN CONTENT LABELING
K070619 · Wrp Asia Pacific Sdn. Bhd. · Jun 2007
TRIFLEX SELECT
K070647 · Cardinal Health, Inc. · Jun 2007
ZIMMER CUT RESISTANT GLOVE LINER, XSMALL, SMALL, MEDIUM, LARGE, XLARGE
K063582 · Zimmer, Inc. · Apr 2007
POWDER FREE STERILE NITRILE SURGICAL GLOVES (BLUE)
K062950 · Hartalega Sdn Bhd · Dec 2006
BIOGEL ECLIPSE INDICATOR UNDERGLOVE
K062847 · Molnlycke Health Care Us, LLC · Dec 2006
CARDINAL HEALTH PROTEGRITY BLUE WITH NEU-THERA SURGICAL GLOVES
K053272 · Cardinalhealth · Jan 2006