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FDA 510(k)

Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein

K-Number: K250069 · 2025-04-29

ApplicantComfort Rubber Gloves Industries Sdn. Bhd.
Decision Date2025-04-29
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein is a medical device manufactured by Comfort Rubber Gloves Industries Sdn. Bhd.. It received FDA 510(k) clearance on 2025-04-29 under approval number K250069. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein?

Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein is a medical device that received FDA 510(k) clearance on 2025-04-29. It is manufactured by Comfort Rubber Gloves Industries Sdn. Bhd.. The 510(k) number is K250069.

When was Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein approved by the FDA?

Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein received FDA 510(k) clearance on 2025-04-29, under approval number K250069.

What company makes Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein?

Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein is manufactured by Comfort Rubber Gloves Industries Sdn. Bhd..

What is the FDA product code for Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein?

The FDA product code for Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein is LYY.

Related Clinical Trials

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Related PubMed Literature

PMID: 42026173 De novo chemo-optogenetics through the rational design of photoresponsive molecules and selection of their artificial protein binding pairs. Nature chemistry (2026)

Other Devices by Comfort Rubber Gloves Industries Sdn. Bhd.

K171541Powder Free Nitrile Examination Gloves (Orange) K162405Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (White); Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (Blue) K180476Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs K190080Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black) K192954Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl K200181Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

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Related Devices (Code: LYY)

K162175Powder Free Latex Examination Glove with Protein Labeling Claim of 50ug/dm2 or lessVietglove Corporation K161006Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of GloveHartalega Sdn Bhd K153744A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein)A1 Glove Sdn Bhd K152593LATEX EXAMINATION GLOVE POWDER FREECareplus (M) Sdn Bhd K170094POWDER FREE LATEX EXAMINATION GLOVE, POLYMER COATEDVietglove Corporation K170779Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable proteinTerang Nusa Sdn Bhd

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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