Cleared Traditional

K213739 - Nitrile Examination Gloves

K213739 is an FDA 510(k) clearance for Nitrile Examination Gloves, manufactured by Hangzhou Runheng Medical Co., Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K213739 · Hangzhou Runheng Medical Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2022
Decision
205d
Days
Class 1
Risk

K213739 is an FDA 510(k) clearance for the Nitrile Examination Gloves. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Hangzhou Runheng Medical Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on June 22, 2022 after a review of 205 days - an extended review 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: 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 Hangzhou Runheng Medical Co., Ltd. devices

FDA 510(k) Submission Details - K213739

510(k) Number K213739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 2021
Decision Date June 22, 2022
Days to Decision 205 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 129d · This submission: 205d
Pathway characteristics
Predicate-based equivalence.

LZA Device Classification - Class 1, General Controls

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 Peers - LZA Polymer Patient Examination Glove

All 682
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K213739.
Powder Free Nitrile Examination Gloves (Blue)
K220284 · Kgm Gloves Sdn. Bhd. · Jul 2022
Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves
K220825 · American Nitrile Operations, LLC · Jul 2022
Powder Free Nitrile Examination Glove
K220834 · Daxwell, LLC · Jun 2022
Disposable Nitrile Powder-Free Examination Gloves
K221192 · Shandong Maida Medical Technology Co., Ltd. · Jun 2022
Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile
K220431 · One Glove Industrial Sdn Bhd · Jun 2022
TC Gloves
K221186 · Thanh Cong Pharmaceutical and Trading Company Limited · Jun 2022