Cleared Traditional

K183280 - PowderFree White Blue Sterilized Nitril...

K183280 is an FDA 510(k) clearance for PowderFree White Blue Sterilized Nitril..., manufactured by Smart Glove Corporation Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K183280 · Smart Glove Corporation Sdn. Bhd. · General Hospital
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Jul 2019
Decision
245d
Days
Class 1
Risk

K183280 is an FDA 510(k) clearance for the PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested .... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Smart Glove Corporation Sdn. Bhd. (Klang, MY). The FDA issued a Cleared decision on July 26, 2019 after a review of 245 days - an extended review 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: 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 Smart Glove Corporation Sdn. Bhd. devices

FDA 510(k) Submission Details - K183280

510(k) Number K183280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2018
Decision Date July 26, 2019
Days to Decision 245 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
116d slower than avg
Panel avg: 129d · This submission: 245d
Pathway characteristics
Predicate-based equivalence.

LZA Device Classification - Class 1, General Controls

Product Code LZA Polymer Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers That May Or May Not Bear A Trace Amount Of Residual Powder, 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.

Regulatory Peers - LZA Polymer Patient Examination Glove

All 684
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K183280.
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Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue, Tested for Use With Chemotherapy Drugs
K190403 · Ever Global (Vietnam) Enterprise Corporation · Sep 2019
Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs
K182089 · Platinum Glove Industries Sdn. Bhd. · Jul 2019
Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black)
K190080 · Comfort Rubber Gloves Industries Sdn. Bhd. · Jun 2019
SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs
K182851 · O&M Halyard, Inc. · Jun 2019
Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate
K183354 · Gx Corporation Sdn Bhd · Jun 2019