Cleared Traditional

Blue Nitrile Exam Glove, Powder Free (K210058) - FDA 510(k) Clearance

Class I General Hospital device.

K210058 · Great Harvest Trading Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2021
Decision
78d
Days
Class 1
Risk

K210058 is an FDA 510(k) clearance for the Blue Nitrile Exam Glove, Powder Free. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Great Harvest Trading Co., Ltd. (Dongying, CN). The FDA issued a Cleared decision on March 30, 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 Great Harvest Trading Co., Ltd. devices

Submission Details

510(k) Number K210058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2021
Decision Date March 30, 2021
Days to Decision 78 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
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 K210058.
Disposable Nitrile Gloves
K210276 · Fujian Ercon Medical Management Co., Ltd. · Apr 2021
Nitrile Examination Gloves
K210106 · Zhenjiang Huayang Latex Products Co., Ltd. · Apr 2021
Blue Nitrile Exam Glove, Powder Free
K210057 · Real Star Medical Technology Co., Ltd. · Mar 2021
Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs
K202083 · Shen Wei (Usa), Inc. · Mar 2021
Biodegradable Powder Free Nitroprene Examination Glove, Low Dermatitis Potential Claim, Teal-Black Color
K202080 · Shen Wei (Usa), Inc. · Mar 2021
Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue
K202081 · Shen Wei (Usa), Inc. · Mar 2021