Cleared Traditional

Synguard Nitrile Exam Glove (K220442) - FDA 510(k) Clearance

Class I General Hospital device.

K220442 · Tianjin Aoshang Outdoor Equipment Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2022
Decision
85d
Days
Class 1
Risk

K220442 is an FDA 510(k) clearance for the Synguard Nitrile Exam Glove. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Tianjin Aoshang Outdoor Equipment Co., Ltd. (Tianjin, CN). The FDA issued a Cleared decision on May 12, 2022 after a review of 85 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 Tianjin Aoshang Outdoor Equipment Co., Ltd. devices

Submission Details

510(k) Number K220442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2022
Decision Date May 12, 2022
Days to Decision 85 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
44d faster than avg
Panel avg: 129d · This submission: 85d
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

Mid-Link Consulting Co, Ltd.
Diana Hong

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 K220442.
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K220429 · One Glove Industrial Sdn Bhd · May 2022
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K220118 · Kl-Kepong Rubber Products Sdn. Bhd. · May 2022
Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs
K220250 · Grand Work Plastic Products Co., Ltd. · May 2022
White Nitrile Powder-Free Patient Examination Glove, Non Sterile
K220427 · One Glove Industrial Sdn Bhd · May 2022
Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile
K220428 · One Glove Industrial Sdn Bhd · May 2022