Cleared Traditional

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

K211758 is an FDA 510(k) clearance for Polychloroprene Powder Free Examination..., manufactured by Hartalega NGC Sdn. Bhd.. The device is a Class 1 General Hospital device with product code OPC cleared through the Traditional 510(k) pathway after a 57-day FDA review.

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

FDA 510(k) Submission Details - K211758

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
72d faster than avg
Panel avg: 129d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

OPC Device Classification - Class 1, General Controls

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.