Cleared Traditional

Blue Nitrile Exam Gloves (K211341) - FDA 510(k) Clearance

Class I General Hospital device.

K211341 · Jiangxi Surefine Medical Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2021
Decision
87d
Days
Class 1
Risk

K211341 is an FDA 510(k) clearance for the Blue Nitrile Exam Gloves. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Jiangxi Surefine Medical Co., Ltd. (Shangrao, CN). The FDA issued a Cleared decision on July 29, 2021 after a review of 87 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 Jiangxi Surefine Medical Co., Ltd. devices

Submission Details

510(k) Number K211341 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2021
Decision Date July 29, 2021
Days to Decision 87 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
42d faster than avg
Panel avg: 129d · This submission: 87d
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 K211341.
Disposable Nitrile Medical Examination Glove
K210691 · Jiangsu Cureguard Glove Co., Ltd. · Jul 2021
Disposable Nitrile Examination Gloves
K211264 · Shenzhen Shiqiao Science and Technology Co., Ltd. · Jul 2021
Disposable Nitrile Medical Examination Glove
K211131 · Siyang Threeguard Medical Supplies Co., Ltd. · Jul 2021
Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors
K211455 · Shen Wei (Usa), Inc. · Jul 2021
Nitrile Patient Examination Gloves
K211012 · Huayuan Medical Technology(Shangqiu) Co., Ltd. · Jul 2021
Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs
K211220 · Guangdong Kingfa Sci. & Tech.Co., Ltd. · Jul 2021