Cleared Traditional

K214074 - Latex Powder Free Surgical Glove with P...

K214074 is the FDA 510(k) clearance for Latex Powder Free Surgical Glove with P... by Hartalega NGC Sdn. Bhd.. It is a Class 1 General Hospital device (product code KGO) cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K214074 · Hartalega NGC Sdn. Bhd. · General Hospital
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May 2022
Decision
150d
Days
Class 1
Risk

K214074 is an FDA 510(k) clearance for the Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram .... Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Hartalega NGC Sdn. Bhd. (Sepang, MY). The FDA issued a Cleared decision on May 26, 2022 after a review of 150 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 Hartalega NGC Sdn. Bhd. devices

Submission Details

510(k) Number K214074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2021
Decision Date May 26, 2022
Days to Decision 150 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 129d · This submission: 150d
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 164
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K214074.
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K221748 · Guilin Hbm Health Protections, Inc. · Sep 2022
Disposable Sterilized Latex Surgical Gloves
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Sterile Latex Surgical Gloves Powder Free
K212596 · Amazing Rubber Products Pvt, Ltd. · Mar 2022
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K212848 · Pentavest Holdings Sdn Bhd · Dec 2021