Cleared Traditional

Nitrile Examination Gloves (Powder free, Blue) (K213029) - FDA 510(k) Clearance

Class I General Hospital device.

K213029 · Weihai Hongyu Nonwoven Fabric Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2021
Decision
84d
Days
Class 1
Risk

K213029 is an FDA 510(k) clearance for the Nitrile Examination Gloves (Powder free, Blue). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Weihai Hongyu Nonwoven Fabric Products Co., Ltd. (Weihai, CN). The FDA issued a Cleared decision on December 14, 2021 after a review of 84 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 Weihai Hongyu Nonwoven Fabric Products Co., Ltd. devices

Submission Details

510(k) Number K213029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2021
Decision Date December 14, 2021
Days to Decision 84 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
45d faster than avg
Panel avg: 129d · This submission: 84d
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 Believe-Med Technology Service Co., Ltd.
Ray 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 K213029.
AT
K212645 · At Glove Engineering Sdn. Bhd · Dec 2021
Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With Chemotherapy Drugs
K212898 · Rimba Glove Snd Bhd · Dec 2021
Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs)
K212919 · Jiujiang Taixin Technology Co., Ltd. · Dec 2021
Non Sterile Nitrile Powder Free Examination Gloves – Blue, Green and Black color
K210388 · Mexpo International, Inc. · Dec 2021
Nitrile Examination Gloves
K212924 · Shanxi Nacosa Medical Technology Co.,Ltd · Dec 2021
Disposable Nitrile Powder-Free Examination Gloves
K213176 · Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd. · Dec 2021