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)

Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)

K-Number: K211621 · 2021-10-06

ApplicantCareplus (M) Sdn Bhd
Decision Date2021-10-06
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less) is a medical device manufactured by Careplus (M) Sdn Bhd. It received FDA 510(k) clearance on 2021-10-06 under approval number K211621. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)?

Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less) is a medical device that received FDA 510(k) clearance on 2021-10-06. It is manufactured by Careplus (M) Sdn Bhd. The 510(k) number is K211621.

When was Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less) approved by the FDA?

Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less) received FDA 510(k) clearance on 2021-10-06, under approval number K211621.

What company makes Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)?

Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less) is manufactured by Careplus (M) Sdn Bhd.

What is the FDA product code for Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)?

The FDA product code for Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less) is KGO.

Related Clinical Trials

NCT07185191 Evaluation of the Safety and Performance of the Medical Device RDM36 in the Treatment of Periodontal Gingival Contraction and in Black Triangles Syndrome (BTS) RECRUITING NCT07372638 Sensorised Surgical Gloves for Neuroendovascular Procedures NOT_YET_RECRUITING NCT07212855 Use of Glycine Powder and an Angled Implant Brush in Oral Hygiene Procedures in Patients Rehabilitated With Columbus Bridge Protocol COMPLETED NCT05989750 Air-polishing With Erythritol During Orthodontic Tretament RECRUITING NCT06849856 Evaluation of the Efficacy of Different Non-Surgical Peri-implantitis Treatment Approaches COMPLETED NCT06388993 Marrow Cellution™ vs. Traditional BMA Harvest Project RECRUITING

Other Devices by Careplus (M) Sdn Bhd

K152593LATEX EXAMINATION GLOVE POWDER FREE K162858NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST K203705Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein) K201857Powder Free Nitrile Examination Glove Black and Dual Color White-Blue K210724ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Standard, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs K210656ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50 µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs

View all 8 devices →

Related Devices (Code: KGO)

K160928Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green)Hartalega Sdb. Bhd. K160974Gammex Cut-Resistant Glove LinerAnsell Healthcare Products, LLC K161008POLYISOPRENE POWDER FREE SURGICAL UNDERGLOVE, POLYISOPRENE POWDER FREE SURGICAL GLOVEHartalega Sdn Bhd K160875Cardinal Health Sterile Polyisoprene Powder-Free Orthopedic Surgical Gloves with Hydrogel CoatingCardinal Health, Inc. K153316Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow)Cardinal Health, Inc. K152428SensiCare PI Surgical GlovesMedline Industries, Inc.

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.

↑