Cleared Traditional

K150609 - Annuy Latex Surgeon's Gloves (Powdered ...

K150609 is an FDA 510(k) clearance for Annuy Latex Surgeon's Gloves (Powdered ..., manufactured by Anhui Anyu Latex Products Co., Ltd.. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 251-day FDA review.

K150609 · Anhui Anyu Latex Products Co., Ltd. · General Hospital
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Nov 2015
Decision
251d
Days
Class 1
Risk

K150609 is an FDA 510(k) clearance for the Annuy Latex Surgeon's Gloves (Powdered and Powder Free). Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Anhui Anyu Latex Products Co., Ltd. (Bengbu, CN). The FDA issued a Cleared decision on November 16, 2015 after a review of 251 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 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 Anhui Anyu Latex Products Co., Ltd. devices

FDA 510(k) Submission Details - K150609

510(k) Number K150609 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2015
Decision Date November 16, 2015
Days to Decision 251 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d slower than avg
Panel avg: 129d · This submission: 251d
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 275
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