Cleared Traditional

K191898 - Sterile Latex Powder-Free Surgical Gloves

K191898 is the FDA 510(k) clearance for Sterile Latex Powder-Free Surgical Gloves by Modern Healthcare Corp.. It is a Class 1 General Hospital device (product code KGO) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K191898 · Modern Healthcare Corp. · General Hospital
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Dec 2019
Decision
155d
Days
Class 1
Risk

K191898 is an FDA 510(k) clearance for the Sterile Latex Powder-Free Surgical Gloves. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Modern Healthcare Corp. (Chang-Hwa, TW). The FDA issued a Cleared decision on December 18, 2019 after a review of 155 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 Modern Healthcare Corp. devices

Submission Details

510(k) Number K191898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2019
Decision Date December 18, 2019
Days to Decision 155 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
26d slower than avg
Panel avg: 129d · This submission: 155d
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 Consultant

Chinese-European Industrial Research Society
Ke-Min Jen

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 164
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K191898.
SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated with Aloe V
K191915 · Medline Industries, Inc. · Mar 2020
SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with Chemotherapy Drugs)
K192820 · Medline Industries, Inc. · Feb 2020
Sterile Latex Surgical Glove, Powder Free
K190241 · Careglove Global Sdn. Bhd. · Dec 2019
Latex Surgeon’s Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein
K190632 · Lenora Glove Pvt , Ltd. · Oct 2019
Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove
K183536 · Hartalega NGC Sdn. Bhd. · Aug 2019
Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove
K183389 · Hartalega NGC Sdn. Bhd. · Jun 2019