Cleared Traditional

Sterile Latex Surgical Glove, Powder Free (K190241) - FDA 510(k) Clearance

Class I General Hospital device.

K190241 · Careglove Global Sdn. Bhd. · General Hospital
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Dec 2019
Decision
327d
Days
Class 1
Risk

K190241 is an FDA 510(k) clearance for the Sterile Latex Surgical Glove, Powder Free. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Careglove Global Sdn. Bhd. (Seremban, MY). The FDA issued a Cleared decision on December 30, 2019 after a review of 327 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Careglove Global Sdn. Bhd. devices

Submission Details

510(k) Number K190241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2019
Decision Date December 30, 2019
Days to Decision 327 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
198d slower than avg
Panel avg: 129d · This submission: 327d
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 96
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K190241.
JR.MEDIK Latex Surgeon’s Gloves Powder Free
K192328 · Jr Engineering & Medical Technologies (M) Sdn. Bhd. · Mar 2020
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 Powder-Free Surgical Gloves
K191898 · Modern Healthcare Corp. · 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