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)

Powder Free Nitrile Examination Glove Black and Dual Color White-Blue

K-Number: K201857 · 2021-08-20

ApplicantCareplus (M) Sdn Bhd
Decision Date2021-08-20
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder Free Nitrile Examination Glove Black and Dual Color White-Blue is a medical device manufactured by Careplus (M) Sdn Bhd. It received FDA 510(k) clearance on 2021-08-20 under approval number K201857. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Powder Free Nitrile Examination Glove Black and Dual Color White-Blue?

Powder Free Nitrile Examination Glove Black and Dual Color White-Blue is a medical device that received FDA 510(k) clearance on 2021-08-20. It is manufactured by Careplus (M) Sdn Bhd. The 510(k) number is K201857.

When was Powder Free Nitrile Examination Glove Black and Dual Color White-Blue approved by the FDA?

Powder Free Nitrile Examination Glove Black and Dual Color White-Blue received FDA 510(k) clearance on 2021-08-20, under approval number K201857.

What company makes Powder Free Nitrile Examination Glove Black and Dual Color White-Blue?

Powder Free Nitrile Examination Glove Black and Dual Color White-Blue is manufactured by Careplus (M) Sdn Bhd.

What is the FDA product code for Powder Free Nitrile Examination Glove Black and Dual Color White-Blue?

The FDA product code for Powder Free Nitrile Examination Glove Black and Dual Color White-Blue is LZA.

Related Clinical Trials

NCT01174108 Allogeneic Hematopoietic Stem Cell Transplantation for Severe Aplastic Anemia and Other Bone Marrow Failure Syndromes Using G-CSF Mobilized CD34+ Selected Hematopoietic Precursor Cells Co-Infused With a Reduced Dose of Non-Mobilized Donor T-cells RECRUITING NCT03258580 Sociocultural & Biobehavioral Influences on Pain Expression and Assessment RECRUITING NCT06968845 A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis RECRUITING NCT05989750 Air-polishing With Erythritol During Orthodontic Tretament RECRUITING NCT07532330 Tyrosine Vs Tacrolimus With NB-UVB in Vitiligo ACTIVE_NOT_RECRUITING NCT06849856 Evaluation of the Efficacy of Different Non-Surgical Peri-implantitis Treatment Approaches COMPLETED

Other Devices by Careplus (M) Sdn Bhd

K152593LATEX EXAMINATION GLOVE POWDER FREE K162858NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST K211621Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less) K203705Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein) 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: LZA)

K161215Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy DrugsBrightway Holdings Sdn. Bhd. K161932Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove PinkTerang Nusa Sdn Bhd K161944Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy DrugsShandong Baisheng Medical Products Co., Ltd. K161074Powder Free Nitrile Examination Gloves Flock-Lined, Black ColorShen Wei (Usa), Inc. K162113Powder Free Nitrile Examination Gloves (Blue)Nam Viet Glove Joint Stock Company K162095Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)Yty Industry (Manjung) 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.

↑