Cleared Traditional

K211758 - Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour) (FDA 510(k) Clearance)

Class I General Hospital device.

K211758 · Hartalega NGC Sdn. Bhd. · General Hospital
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Aug 2021
Decision
57d
Days
Class 1
Risk

K211758 is an FDA 510(k) clearance for the Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherap.... Classified as Powder-free Polychloroprene Patient Examination Glove (product code OPC), Class I - General Controls.

Submitted by Hartalega NGC Sdn. Bhd. (Sepang, MY). The FDA issued a Cleared decision on August 3, 2021 after a review of 57 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hartalega NGC Sdn. Bhd. devices

Submission Details

510(k) Number K211758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2021
Decision Date August 03, 2021
Days to Decision 57 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
71d faster than avg
Panel avg: 128d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OPC Powder-free Polychloroprene Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Powder Free Polychloroprene Patient Examination Glove Is A Disposable Device Made Of Polychloroprene Rubber Tthat Bears Powder To Facilitate Donning, And Is Intended To Be Worn On The Hand For Medical Purposes 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.