Cleared Traditional

K201748 - Latex Powder Free Surgical Glove with P...

K201748 is the FDA 510(k) clearance for Latex Powder Free Surgical Glove with P... by Hartalega Sdn Bhd. It is a Class 1 General Hospital device (product code KGO) cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K201748 · Hartalega Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2020
Decision
98d
Days
Class 1
Risk

K201748 is an FDA 510(k) clearance for the Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram.... Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Hartalega Sdn Bhd (Bandar Sri Damansara, MY). The FDA issued a Cleared decision on October 2, 2020 after a review of 98 days - within the typical 510(k) review window.

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 Sdn Bhd devices

Submission Details

510(k) Number K201748 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 2020
Decision Date October 02, 2020
Days to Decision 98 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d faster than avg
Panel avg: 129d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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

Third Party Review Group, LLC
Dave Yungvirt

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 143
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K201748.
Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm2 per Glove of Extractable Protein
K202668 · Medline Industries, Inc. · Dec 2020
Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons / Biogel Indicator Underglove, Biogel PI Micro Indicator Underglove, Biogel PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim
K202090 · Molnlycke Health Care Us, LLC · Nov 2020
Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm² per glove of Extractable Protein
K202449 · Medline Industries, Inc. · Nov 2020
Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs
K201774 · Pt. Medisafe Technologies · Sep 2020
SensiCare PI Evolution Surgical Glove (Tested for Use with Chemotherapy Drugs)
K201829 · Medline Industries, Inc. · Sep 2020
Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural)
K200897 · Hartalega Sdn Bhd · Jun 2020

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.