Cleared Traditional

Disposable Nitrile Examination Gloves (Powder free, Blue) (K211581) - FDA 510(k) Clearance

Class I General Hospital device.

K211581 · Leping Shengde Medical Technology Company Limited · General Hospital
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Oct 2021
Decision
160d
Days
Class 1
Risk

K211581 is an FDA 510(k) clearance for the Disposable Nitrile Examination Gloves (Powder free, Blue). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Leping Shengde Medical Technology Company Limited (Jingdezhen, CN). The FDA issued a Cleared decision on October 28, 2021 after a review of 160 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 Leping Shengde Medical Technology Company Limited devices

Submission Details

510(k) Number K211581 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2021
Decision Date October 28, 2021
Days to Decision 160 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
31d slower than avg
Panel avg: 129d · This submission: 160d
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 K211581.
Nitrile Examination Gloves (Blue, Violet)
K211586 · Lyncmed Medical Technology (Beijing) Co., Ltd. · Nov 2021
Black Nitrile Powder Free Patient Examination Glove, Non Sterile
K210588 · Onetexx Sdn Bhd · Oct 2021
SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder Free
K212308 · Srirungruang Global Co., Ltd. · Oct 2021
Examination gloves -Type C (Nitrile gloves)
K212290 · Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd. · Oct 2021
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs
K211604 · Shanxi Hongjin Plastic Technology Co., Ltd. · Oct 2021
Disposable Medical Nitrile Examination Gloves
K212363 · Lanhuo Medical Technology (Jiangsu) Co.,Ltd · Oct 2021