Cleared Traditional

Violet Nitrile Powder Free Patient Examination Glove, Non Sterile (K222721) - FDA 510(k) Clearance

Class I General Hospital device.

K222721 · Safeskin Retailing (Hk) Limited · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2022
Decision
40d
Days
Class 1
Risk

K222721 is an FDA 510(k) clearance for the Violet Nitrile Powder Free Patient Examination Glove, Non Sterile. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Safeskin Retailing (Hk) Limited (Hong Kong, CN). The FDA issued a Cleared decision on October 18, 2022 after a review of 40 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 Safeskin Retailing (Hk) Limited devices

Submission Details

510(k) Number K222721 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2022
Decision Date October 18, 2022
Days to Decision 40 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
89d faster than avg
Panel avg: 129d · This submission: 40d
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

Dawa Medical, LLC
Stephan Toupan

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 K222721.
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
Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid
K222298 · Onetexx Sdn Bhd · Oct 2022
Powder Free Nitrile Examination Gloves (Blue, Black, White and/or Violet Blue), Powder Free Latex Examination Gloves
K222074 · Zibo Langu New Material Technology Co., Ltd. · Oct 2022
Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs
K222714 · Guangdong Kingfa Sci. & Tech.Co., Ltd. · Oct 2022
Disposable Nitrile Examination Glove
K222937 · Jiangsu Cureguard Glove Co., Ltd. · Oct 2022