Cleared Traditional

Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable Powder Free Nitrile Examination Glove, Blue Violet Color, Biodegradable Powder Free Nitrile Examination Glove, Green Color (K221983) - FDA 510(k) Clearance

Class I General Hospital device.

K221983 · Guangdong Kingfa Sci. & Tech.Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2023
Decision
295d
Days
Class 1
Risk

K221983 is an FDA 510(k) clearance for the Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradabl.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Guangdong Kingfa Sci. & Tech.Co., Ltd. (Qingyuan, CN). The FDA issued a Cleared decision on April 27, 2023 after a review of 295 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 Guangdong Kingfa Sci. & Tech.Co., Ltd. devices

Submission Details

510(k) Number K221983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2022
Decision Date April 27, 2023
Days to Decision 295 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
166d slower than avg
Panel avg: 129d · This submission: 295d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 489
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K221983.
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K230121 · Careglove Global Sdn. Bhd. · May 2023
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K223280 · Holik Asia Group Co.,Ltd · May 2023
Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K220088 · Professional Latex Sdn Bhd · Mar 2023
Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy Drugs
K220644 · Yty Industry (Manjung) Sdn Bhd · Mar 2023
Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs
K230002 · Mah Sing Healthcare Sdn. Bhd. · Mar 2023