Cleared Traditional

Single-use medical latex examination gloves (LG100) (K222693) - FDA 510(k) Clearance

Class I General Hospital device.

K222693 · Fitone Latex Products Co., Ltd. Guangdong · General Hospital
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Sep 2022
Decision
18d
Days
Class 1
Risk

K222693 is an FDA 510(k) clearance for the Single-use medical latex examination gloves (LG100). Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Fitone Latex Products Co., Ltd. Guangdong (Zhanjiang, CN). The FDA issued a Cleared decision on September 24, 2022 after a review of 18 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 Fitone Latex Products Co., Ltd. Guangdong devices

Submission Details

510(k) Number K222693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 2022
Decision Date September 24, 2022
Days to Decision 18 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
111d faster than avg
Panel avg: 129d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYY Latex Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex 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

Landlink Healthcare Technology (Shanghai) Co., Ltd.
Stuart Situ

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 - LYY Latex Patient Examination Glove

All 41
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K222693.
Non Sterile Powder Free Latex Examination Glove
K221667 · New Era Medicare Sdn. Bhd. · Oct 2022
JR MEDIC
K222348 · Jr Engineering & Medical Technologies (M) Sdn. Bhd. · Oct 2022
Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)
K221374 · Hebei Titans Hongsen Medical Technology Co., Ltd. · Oct 2022
Iconic Latex Glove
K221648 · Iconic Medicare Sdn Bhd · Aug 2022
Powder Free Latex Examination Glove, Non-Sterile
K211601 · Wrp Asia Pacific Sdn. Bhd. · Aug 2022
Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White
K212482 · Sri Trang Gloves (Thailand) Public Company Limited · Aug 2022