Cleared Traditional

Medical Examination Gloves (Nitrile) (XS, S, M, L, XL) (K222498) - FDA 510(k) Clearance

Class I General Hospital device.

K222498 · Humanwell Healthcare Group Medical Supplies Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2022
Decision
69d
Days
Class 1
Risk

K222498 is an FDA 510(k) clearance for the Medical Examination Gloves (Nitrile) (XS, S, M, L, XL). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Humanwell Healthcare Group Medical Supplies Co., Ltd. (Wuhan, CN). The FDA issued a Cleared decision on October 26, 2022 after a review of 69 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 Humanwell Healthcare Group Medical Supplies Co., Ltd. devices

Submission Details

510(k) Number K222498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 2022
Decision Date October 26, 2022
Days to Decision 69 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
60d faster than avg
Panel avg: 129d · This submission: 69d
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 Sungo Management Consulting Company Limited.
Ivy 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 K222498.
Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K211816 · Brightway Holdings Sdn. Bhd. · Nov 2022
Nitrile Two Toned Blue/Green, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested for Use with the Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit)
K220371 · Summit Glove, Inc. · Nov 2022
Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
K223320 · Lingshi Hongruida Health Protection Technology Co., Ltd. · Nov 2022
Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs)
K223235 · Pt. Sintong Unigolden Glove · Oct 2022
JR MEDIC Nitrile Examination Gloves Powder Free- Black
K221169 · Jr Engineering & Medical Technologies (M) Sdn. Bhd. · Oct 2022
JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple)
K222349 · Jr Engineering & Medical Technologies (M) Sdn. Bhd. · Oct 2022