Cleared Traditional

Nitrile Exam Gloves, Powder Free, Blue (K211699) - FDA 510(k) Clearance

Class I General Hospital device.

K211699 · Hengchang (Dongying) Medical Technology Co., Ltd. · General Hospital
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Aug 2021
Decision
78d
Days
Class 1
Risk

K211699 is an FDA 510(k) clearance for the Nitrile Exam Gloves, Powder Free, Blue. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Hengchang (Dongying) Medical Technology Co., Ltd. (Dongying, CN). The FDA issued a Cleared decision on August 20, 2021 after a review of 78 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hengchang (Dongying) Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K211699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2021
Decision Date August 20, 2021
Days to Decision 78 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
51d faster than avg
Panel avg: 129d · This submission: 78d
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

Shanghai Truthful Information Technology Co., Ltd.
Boyle Wang

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 K211699.
Nitrile Examination Gloves
K211515 · Beijing Reagent Latex Products Co., Ltd. · Aug 2021
Powder Free Nitrile Examination Glove Black and Dual Color White-Blue
K201857 · Careplus (M) Sdn Bhd · Aug 2021
Medical Gloves
K203622 · Beijing Biosis Healing Biolog Ical Technology Co., Ltd. · Aug 2021
Purism Non-Sterile Powder Free Nitrile Examination Gloves
K211319 · Dezhou Purism Medical Technology Co., Ltd. · Aug 2021
Disposable Medical Nitrile Gloves
K211708 · Jiangsu Health-Peace Medical Technology Co., Ltd. · Aug 2021
Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove
K203236 · Rhino Health, Inc. · Aug 2021