Cleared Traditional

K171047 - Sterile Polyisoprene Powder Free Surgical Gloves (FDA 510(k) Clearance)

Class I General Hospital device.

K171047 · Better Care Plastic Technology Co., Ltd. · General Hospital

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Jun 2017

Decision

76d

Days

Class 1

Risk

K171047 is an FDA 510(k) clearance for the Sterile Polyisoprene Powder Free Surgical Gloves. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Better Care Plastic Technology Co., Ltd. (Shenze County, CN). The FDA issued a Cleared decision on June 22, 2017 after a review of 76 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 Better Care Plastic Technology Co., Ltd. devices

Submission Details

510(k) Number	K171047 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 07, 2017
Decision Date	June 22, 2017
Days to Decision	76 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

52d faster than avg

Panel avg: 128d · This submission: 76d

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.