Cleared Traditional

Powder Free Nitrile Patient Examination Gloves, Blue Color (K211860) - FDA 510(k) Clearance

Class I General Hospital device.

K211860 · Anhui Powerguard Technology Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2021
Decision
58d
Days
Class 1
Risk

K211860 is an FDA 510(k) clearance for the Powder Free Nitrile Patient Examination Gloves, Blue Color. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Anhui Powerguard Technology Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on August 13, 2021 after a review of 58 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 Anhui Powerguard Technology Co., Ltd. devices

Submission Details

510(k) Number K211860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2021
Decision Date August 13, 2021
Days to Decision 58 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
71d faster than avg
Panel avg: 129d · This submission: 58d
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

Beijing Easy-Link Company
Chu Xiaoan

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 K211860.
Purism Non-Sterile Powder Free Nitrile Examination Gloves
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K202536 · Yty Industry (Manjung) Sdn Bhd · Aug 2021
Nitrile Patient Examination Glove
K210730 · American Performance Polymers, LLC · Aug 2021
Edma Synthetic Nitrile Examination Gloves
K211540 · Edma Group, LLC · Aug 2021