Cleared Traditional

Disposable Nitrile Gloves (K212009) - FDA 510(k) Clearance

Class I General Hospital device.

K212009 · Jiangsu Shenglijie Safety Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2021
Decision
79d
Days
Class 1
Risk

K212009 is an FDA 510(k) clearance for the Disposable Nitrile Gloves. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Jiangsu Shenglijie Safety Products Co., Ltd. (Nantong, CN). The FDA issued a Cleared decision on September 15, 2021 after a review of 79 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 Jiangsu Shenglijie Safety Products Co., Ltd. devices

Submission Details

510(k) Number K212009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2021
Decision Date September 15, 2021
Days to Decision 79 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
50d faster than avg
Panel avg: 129d · This submission: 79d
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 K212009.
Disposable Nitrile Gloves
K211781 · Jiangsu Jinke Protective Equipment Co., Ltd. · Sep 2021
Disposable Nitrile Examination Gloves
K211073 · Foshan Kangkang Biotechnology Co., Ltd. · Sep 2021
Blue Nitrile Examination Glove Powder Free
K211479 · Aspen Glove Sdn. Bhd. · Sep 2021
Nitrile Examination Gloves Powder Free (Blue)
K210868 · Great Eco Glove Sdn. Bhd. · Sep 2021
Nitrile Examination Gloves, Green/ Blue/ Black Color
K211778 · Zhenjiang Suhui Latex Products Co., Ltd. · Sep 2021
Disposable Medical Nitrile Gloves
K211673 · Changzhou Yihua Sanitation Material Co., Ltd. · Sep 2021