Cleared Traditional

K171047 - Sterile Polyisoprene Powder Free Surgical Gloves

K171047 is an FDA 510(k) clearance for Sterile Polyisoprene Powder Free Surgic..., manufactured by Better Care Plastic Technology Co., Ltd.. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K171047 · Better Care Plastic Technology Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K171047

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 129d · This submission: 76d
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 Consultant

Hongray USA Medical Products, Inc.
Kathy Liu

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KGO Surgeon's Gloves

All 395
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K171047.
Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim
K172420 · Wear Safe Malaysia Sdn. Bhd. · Sep 2017
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Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs
K171898 · Better Care Plastic Technology Co., Ltd. · Aug 2017
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K170198 · Cardinal Health, Inc. · Jun 2017
Sterile Nitrile Surgical Gloves, Powder-free
K170515 · Primus Gloves Pvt Limited · Jun 2017
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K170152 · Hartalega Sdn Bhd · May 2017