Cleared Traditional

K171550 - Sterile Latex Surgical Gloves, Powder Free (FDA 510(k) Clearance)

Class I General Hospital device.

K171550 · Sanrea Healthcare Products Pvt, Ltd. · General Hospital
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Optimized for regulatory review, auditing and printing
Jul 2018
Decision
413d
Days
Class 1
Risk

K171550 is an FDA 510(k) clearance for the Sterile Latex Surgical Gloves, Powder Free. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Sanrea Healthcare Products Pvt, Ltd. (Palakkad, IN). The FDA issued a Cleared decision on July 13, 2018 after a review of 413 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Sanrea Healthcare Products Pvt, Ltd. devices

Submission Details

510(k) Number K171550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2017
Decision Date July 13, 2018
Days to Decision 413 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
285d slower than avg
Panel avg: 128d · This submission: 413d
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 557
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K171550.
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