Cleared Traditional

Powder free nitrile examination glove- black, non sterile (K212801) - FDA 510(k) Clearance

Class I General Hospital device.

K212801 · Hong Seng Gloves Sdn Bhd · General Hospital
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Jan 2022
Decision
129d
Days
Class 1
Risk

K212801 is an FDA 510(k) clearance for the Powder free nitrile examination glove- black, non sterile. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Hong Seng Gloves Sdn Bhd (Sungai Petani, MY). The FDA issued a Cleared decision on January 9, 2022 after a review of 129 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 Hong Seng Gloves Sdn Bhd devices

Submission Details

510(k) Number K212801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 2021
Decision Date January 09, 2022
Days to Decision 129 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
At panel average
Panel avg: 129d · This submission: 129d
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 Consultant

Emergo Global Representative, LLC
Michael Van Der Woude

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K212801.
Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs)
K212735 · Xingyu Medical Tech Co., Ltd. · Jan 2022
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K213168 · Shandong Huiwosheng Health Technology Co.,Ltd · Jan 2022
Powder Free Nitrile Examination Gloves, Blue Chemotest
K211666 · Careglove Global Sdn. Bhd. · Jan 2022
Penta Glove
K212847 · Pentavest Holdings Sdn Bhd · Jan 2022
Disposable Nitrile Medical Powder-free Glove
K213187 · Fujian Chunhui Medical Supply Co., Ltd. · Jan 2022
Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs)
K212834 · Siyang Threeguard Medical Supplies Co., Ltd. · Dec 2021