Decision Date2017-11-28
Product CodeLZC
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Orange Non Sterile Powder Free Nitrile Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is Central Medicare Sdn Bhd. It received FDA 510(k) clearance on 2017-11-28 under 510(k) number K172642. The device is classified under product code LZC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Orange Non Sterile Powder Free Nitrile Examination Gloves?
Orange Non Sterile Powder Free Nitrile Examination Gloves is a medical device that received FDA 510(k) clearance on 2017-11-28. The listed applicant is Central Medicare Sdn Bhd. The 510(k) number is K172642.
When did Orange Non Sterile Powder Free Nitrile Examination Gloves receive FDA 510(k) clearance?
Orange Non Sterile Powder Free Nitrile Examination Gloves received FDA 510(k) clearance on 2017-11-28, under 510(k) number K172642.
Who is the listed applicant for Orange Non Sterile Powder Free Nitrile Examination Gloves?
The FDA 510(k) record lists Central Medicare Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Orange Non Sterile Powder Free Nitrile Examination Gloves?
The FDA product code for Orange Non Sterile Powder Free Nitrile Examination Gloves is LZC.
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Other records listing Central Medicare Sdn Bhd as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
K230681Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and FentanylK223752Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Chloroquine, Cyclosporin A, Retrovir, Gastric Acid and FentanylK230875Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance ClaimsK230564Green Non Sterile Powder Free Nitrile Examination GlovesK213437Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance ClaimsK211022Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims. View all 11 devices →
Related Devices (Code: LZC)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
K252313Cardinal Health Nitrile Examination Gloves Extended CuffCardinalhealthK243959Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other DrugsLingshi Hongruida Health Protection Technology Co., Ltd.K221157JR MedicJr Engineering & Medical Technologies (M) Sdn. Bhd.K222449Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)Better Care Plastic Technology Co., Ltd.K220545Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy DrugsHl Rubber Industries Sdn BhdK220491Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy DrugsHainan Asther Medical Equipment Co., Ltd.
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.