Cleared Traditional

Powder-Free Latex examination gloves

K222612 · Guangdong Kingfa Sci. & Tech.Co., Ltd. · General Hospital
Nov 2022
Decision
87d
Days
Class 1
Risk

About This 510(k) Submission

K222612 is an FDA 510(k) clearance for the Powder-Free Latex examination gloves, a Latex Patient Examination Glove (Class I — General Controls, product code LYY), submitted by Guangdong Kingfa Sci. & Tech.Co., Ltd. (Qingyuan, CN). The FDA issued a Cleared decision on November 25, 2022, 87 days after receiving the submission on August 30, 2022. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6250.

Submission Details

510(k) Number K222612 FDA.gov
FDA Decision Cleared SESE
Date Received August 30, 2022
Decision Date November 25, 2022
Days to Decision 87 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LYY — Latex Patient Examination Glove
Device Class Class I — 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.

Similar Devices — LYY Latex Patient Examination Glove

All 1953
Powder Free Natural Rubber Latex Examination Gloves ? Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein
K250069 · Comfort Rubber Gloves Industries Sdn. Bhd. · Apr 2025
Latex Examination Glove Powder Free (Ocean Blue and Natural White)
K240266 · Sri Trang Gloves (Thailand) Public Company Limited · Sep 2024
Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)
K230573 · Kossan International Sdn Bhd · Jun 2023
Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)
K223298 · Shandong Intco Medical Products Co, Ltd. · Feb 2023
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

More from Guangdong Kingfa Sci. &...

View all
Medical surgical mask
K233723 · FXX · Jul 2024
Biodegradable Medical surgical mask
K231155 · FXX · Nov 2023
Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable Powder Free Nitrile Examination Glove, Blue Violet Color, Biodegradable Powder Free Nitrile Examination Glove, Green Color
K221983 · LZA · Apr 2023
Vinyl examination gloves
K230046 · LYZ · Mar 2023
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 · LZA · Oct 2022