Cleared Traditional

Powder Free Blue Nitrile Examination Gloves (K213107) - FDA 510(k) Clearance

Class I General Hospital device.

K213107 · Novid Ppe Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
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

Submission Details

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.

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 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