Cleared Traditional

K213107 - Powder Free Blue Nitrile Examination Gloves

K213107 is an FDA 510(k) clearance for Powder Free Blue Nitrile Examination Gloves, manufactured by Novid Ppe Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K213107 · Novid Ppe Sdn. Bhd. · General Hospital
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Optimized for regulatory review, auditing and printing
Feb 2022
Decision
146d
Days
Class 1
Risk

K213107 is an FDA 510(k) clearance for the Powder Free Blue Nitrile Examination Gloves. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Novid Ppe Sdn. Bhd. (Klang, MY). The FDA issued a Cleared decision on February 17, 2022 after a review of 146 days - within the typical 510(k) review window.

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 Novid Ppe Sdn. Bhd. devices

FDA 510(k) Submission Details - K213107

510(k) Number K213107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2021
Decision Date February 17, 2022
Days to Decision 146 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 129d · This submission: 146d
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 K213107.
Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs
K213440 · Luliang Hongruida Health Protection Technology Co., Ltd. · Feb 2022
Nitrile Examination Gloves (Model: ZMG1351)
K213688 · Wuhan Zonsen Medical Products Co., Ltd. · Feb 2022
Amazing+
K212586 · Amazing Rubber Products Pvt, Ltd. · Feb 2022
O'Star Nitrile Examination Gloves Powder Free
K213058 · Star Investment and Trade Joint Stock Company · Feb 2022
Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate Simulated Gastric Acid Solution
K213142 · Shen Wei (Usa), Inc. · Jan 2022
Thermoplastic Elastomer (TPE) Hybrid Examination Glove
K210463 · Xuzhou Full Sun Medical Products , Ltd. · Jan 2022