Cleared Traditional

K063757 - MOTEX POWDER-FREE SURGICAL GLOVES AND LIGHTLY POWDERED SURGICAL GLOVES (FDA 510(k) Clearance)

Class I General Hospital device.

K063757 · Shanghai Motex Healthcare Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2007
Decision
220d
Days
Class 1
Risk

K063757 is an FDA 510(k) clearance for the MOTEX POWDER-FREE SURGICAL GLOVES AND LIGHTLY POWDERED SURGICAL GLOVES. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Shanghai Motex Healthcare Co., Ltd. (Hsin Chu City, TW). The FDA issued a Cleared decision on July 27, 2007 after a review of 220 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 Shanghai Motex Healthcare Co., Ltd. devices

Submission Details

510(k) Number K063757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2006
Decision Date July 27, 2007
Days to Decision 220 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
91d slower than avg
Panel avg: 129d · This submission: 220d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 558
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K063757.
Sterile Latex Powder Free Surgical Gloves
K253060 · Protect Gloves Company Limited · May 2026
Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid
K250313 · Harps Europe Manufacturing GmbH · Aug 2025
Polyisoprene Surgical gloves
K240790 · Suzhou Colour-Way New Material Co., Ltd. · Aug 2024
Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green)
K232079 · Wrp Asia Pacific Sdn. Bhd. · Mar 2024
Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs
K232444 · Grand Work Plastic Products Co., Ltd. · Dec 2023
GAMMEX PI Hybrid Micro (340002055)
K231902 · Ansell Healthcare · Oct 2023