Cleared Traditional

Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs) (K212834) - FDA 510(k) Clearance

Class I General Hospital device.

K212834 · Siyang Threeguard Medical Supplies Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2021
Decision
114d
Days
Class 1
Risk

K212834 is an FDA 510(k) clearance for the Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherap.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Siyang Threeguard Medical Supplies Co., Ltd. (Suqian, CN). The FDA issued a Cleared decision on December 30, 2021 after a review of 114 days - within the typical 510(k) review window.

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 Siyang Threeguard Medical Supplies Co., Ltd. devices

Submission Details

510(k) Number K212834 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2021
Decision Date December 30, 2021
Days to Decision 114 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
15d faster than avg
Panel avg: 129d · This submission: 114d
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 K212834.
Powder free nitrile examination glove- black, non sterile
K212801 · Hong Seng Gloves Sdn Bhd · Jan 2022
Penta Glove
K212847 · Pentavest Holdings Sdn Bhd · Jan 2022
Disposable Nitrile Medical Powder-free Glove
K213187 · Fujian Chunhui Medical Supply Co., Ltd. · Jan 2022
ATM Glove
K213016 · Phu Duc Huy Production Trading Services Corporation · Dec 2021
Dermoaroma Disposable Nitrile Examination Glove
K212716 · Chuzhou Harmony Gloves Medical Technology Co.,Ltd · Dec 2021
Nitrile Examination Golves Powder Free
K212921 · Jiangsu Standard Health Co.,Ltd · Dec 2021