510(k) K250069

Device
Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein
Applicant
Comfort Rubber Gloves Industries Sdn. Bhd.
510(k) number
K250069
Product code
LYY
Decision
Substantially Equivalent (SESE)
Decision date
2025-04-29
Date received
2025-01-10
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
N

Applicant Contact#

Contact
Sumathi Saravana Sami
Address
Lot 821 Jalan Matang Matang MY 34750 34750

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
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
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K222348JR MEDICJr Engineering & Medical Technologies (M) Sdn. Bhd.2022-10-27
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K222693Single-use medical latex examination gloves (LG100)Fitone Latex Products Co., Ltd. Guangdong2022-09-24
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K212597Amazing+ Latex Examination Powder Free GlovesAmazing Rubber Products Pvt, Ltd.2022-05-28
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