510(k) K223298

Device
Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)
Applicant
Shandong Intco Medical Products Co, Ltd.
510(k) number
K223298
Product code
LYY
Decision
Substantially Equivalent (SESE)
Decision date
2023-02-22
Date received
2022-10-27
Regulation
880.6250
Classification name
Latex Patient Examination Glove
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Min Gao
Address
9888 Qiwang Rd., Naoshan Industrial Park Qingzhou CN 2625000 2625000

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LYY#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K250069Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less ProteinComfort Rubber Gloves Industries Sdn. Bhd.2025-04-29
K240266Latex Examination Glove Powder Free (Ocean Blue and Natural White)Sri Trang Gloves (Thailand) Public Company Limited2024-09-09
K230573Powder 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)Kossan International Sdn Bhd2023-06-13
K222612Powder-Free Latex examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd.2022-11-25
K221667Non Sterile Powder Free Latex Examination GloveNew Era Medicare Sdn. Bhd.2022-10-28
K222348JR MEDICJr Engineering & Medical Technologies (M) Sdn. Bhd.2022-10-27
K221374Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL)Hebei Titans Hongsen Medical Technology Co., Ltd.2022-10-26
K222693Single-use medical latex examination gloves (LG100)Fitone Latex Products Co., Ltd. Guangdong2022-09-24
K221648Iconic Latex GloveIconic Medicare Sdn Bhd2022-08-25
K211601Powder Free Latex Examination Glove, Non-SterileWrp Asia Pacific Sdn. Bhd.2022-08-22
K212482Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural WhiteSri Trang Gloves (Thailand) Public Company Limited2022-08-09
K214017Examination gloves-Type A(Latex gloves)Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.2022-07-14
K221185TC GlovesThanh Cong Pharmaceutical and Trading Company Limited2022-06-22
K212597Amazing+ Latex Examination Powder Free GlovesAmazing Rubber Products Pvt, Ltd.2022-05-28
K213775Glovatex™ White Latex Gloves, Glovanil™ Blue Nitrile GlovesAvecena Gloves Sdn Bhd2022-04-24