Single-use medical latex examination gloves (LG100)

FDA 510(k) K222693 · Fitone Latex Products Co., Ltd. Guangdong

Substantially Equivalent

510(k) numberK222693

Submission

Device name
Single-use medical latex examination gloves (LG100)
Applicant
Fitone Latex Products Co., Ltd. Guangdong
Zhanjiang, CN
Received
September 6, 2022
Decision date
September 24, 2022
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LYY – Latex Patient Examination Glove
Device class
Class I (low risk)
Regulation
21 CFR 880.6250
Specialty
General Hospital

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.

Other 510(k)s with product code LYY

510(k)DeviceApplicantDecision
K250069Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein…LYY · Traditional Comfort Rubber Gloves Industries Sdn. Bhd.04/29/2025SE
K240266Latex Examination Glove Powder Free (Ocean Blue and Natural White)LYY · Abbreviated Sri Trang Gloves (Thailand) Public Company Limited09/09/2024SE
K230573Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein…LYY · Traditional Kossan International Sdn Bhd06/13/2023SE
K223298Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)LYY · Traditional Shandong Intco Medical Products Co, Ltd.02/22/2023SE
K222612Powder-Free Latex examination glovesLYY · Traditional Guangdong Kingfa Sci. & Tech.Co., Ltd.11/25/2022SE
K221667Non Sterile Powder Free Latex Examination GloveLYY · Traditional New Era Medicare Sdn. Bhd.10/28/2022SE
K222348JR MedicLYY · Abbreviated Jr Engineering & Medical Technologies (M) Sdn.…10/27/2022SE
K221374Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)LYY · Traditional Hebei Titans Hongsen Medical Technology Co., Ltd.10/26/2022SE
K221648Iconic Latex GloveLYY · Traditional Iconic Medicare Sdn Bhd08/25/2022SE
K211601Powder Free Latex Examination Glove, Non-SterileLYY · Traditional Wrp Asia Pacific Sdn. Bhd.08/22/2022SE

More from Wrp Asia Pacific Sdn. Bhd.

510(k)DeviceDecision
K231446Single-Use Latex Sterile Surgical Gloves (SG100)KGO · Traditional 09/22/2023SE
K221747Nitrile Patient Examination Gloves Tested For Use With Chemotherapy DrugsLZA · Traditional 12/01/2022SE
K211927Nitrile examination glovesLZA · Traditional 10/12/2021SE

Questions and answers

When was Single-use medical latex examination gloves (LG100) cleared by the FDA?

Single-use medical latex examination gloves (LG100) (K222693) received a 510(k) decision of Substantially Equivalent on September 24, 2022, 18 days after the submission was received.

What is the product code of K222693?

The FDA product code is LYY – Latex Patient Examination Glove, a Class I (low risk) device regulated under 21 CFR 880.6250.