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FDA 510(k)

Non Sterile Powder Free Latex Examination Glove

K-Number: K221667 · 2022-10-28

ApplicantNew Era Medicare Sdn. Bhd.
Decision Date2022-10-28
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Non Sterile Powder Free Latex Examination Glove is a medical device manufactured by New Era Medicare Sdn. Bhd.. It received FDA 510(k) clearance on 2022-10-28 under approval number K221667. 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 Non Sterile Powder Free Latex Examination Glove?

Non Sterile Powder Free Latex Examination Glove is a medical device that received FDA 510(k) clearance on 2022-10-28. It is manufactured by New Era Medicare Sdn. Bhd.. The 510(k) number is K221667.

When was Non Sterile Powder Free Latex Examination Glove approved by the FDA?

Non Sterile Powder Free Latex Examination Glove received FDA 510(k) clearance on 2022-10-28, under approval number K221667.

What company makes Non Sterile Powder Free Latex Examination Glove?

Non Sterile Powder Free Latex Examination Glove is manufactured by New Era Medicare Sdn. Bhd..

What is the FDA product code for Non Sterile Powder Free Latex Examination Glove?

The FDA product code for Non Sterile Powder Free Latex Examination Glove is LYY.

Related Clinical Trials

NCT06968845 A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis RECRUITING NCT07247825 Efficacy of Therapeutic Percutaneous Electrolysis vs Laser Therapy in Supraspinatus Tendinopathy. RECRUITING NCT06849856 Evaluation of the Efficacy of Different Non-Surgical Peri-implantitis Treatment Approaches COMPLETED

Other Devices by New Era Medicare Sdn. Bhd.

K230314Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors) K221424Sterile Surgical Powder Free Latex Glove

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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