Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

A1 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)

K-Number: K153744 · 2016-08-04

ApplicantA1 Glove Sdn Bhd
Decision Date2016-08-04
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

A1 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) is a medical device manufactured by A1 Glove Sdn Bhd. It received FDA 510(k) clearance on 2016-08-04 under approval number K153744. 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 A1 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 Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) is a medical device that received FDA 510(k) clearance on 2016-08-04. It is manufactured by A1 Glove Sdn Bhd. The 510(k) number is K153744.

When was A1 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) approved by the FDA?

A1 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) received FDA 510(k) clearance on 2016-08-04, under approval number K153744.

What company makes A1 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 Powder Free Latex Patient Examination Gloves with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) is manufactured by A1 Glove Sdn Bhd.

What is the FDA product code for A1 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)?

The FDA product code for A1 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) is LYY.

Related Clinical Trials

NCT07027826 The Esophageal String Test as a Diagnostic Screening Tool for Eosinophilic Esophagitis Among Africans With Dysphagia in Mali and the United States RECRUITING NCT07615972 Efficacy of a Roller Device Facilitating Self-massage in the Treatment of Chronic Lateral Epicondylitis NOT_YET_RECRUITING NCT06915402 Efficacy and Safety of "LMW - CL - HA - FACE/BODY" for the Augmentation of the Cheeks COMPLETED NCT05934487 PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III RECRUITING NCT07589452 Impact of Allometric Pacing Rate on Ventricular Diastolic Function and Cerebral Blood Flow in Hypertensive Patients With Sinus Node Dysfunction NOT_YET_RECRUITING NCT07467915 Combined Mirror Therapy and Soft Robotic Glove for Hand Recovery After Stroke RECRUITING

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 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 K161833LATEX EXAMINATION GLOVE POWDER FREECareglove Global 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.

↑