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FDA 510(k)

Nitrile Powder Free Blue Examination Gloves, Non-Sterile

K-Number: K212535 · 2021-12-04

ApplicantMah Sing Healthcare Sdn. Bhd.
Decision Date2021-12-04
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Nitrile Powder Free Blue Examination Gloves, Non-Sterile is the device name listed in this FDA 510(k) record. The listed applicant is Mah Sing Healthcare Sdn. Bhd.. It received FDA 510(k) clearance on 2021-12-04 under 510(k) number K212535. 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 Nitrile Powder Free Blue Examination Gloves, Non-Sterile?

Nitrile Powder Free Blue Examination Gloves, Non-Sterile is a medical device that received FDA 510(k) clearance on 2021-12-04. The listed applicant is Mah Sing Healthcare Sdn. Bhd.. The 510(k) number is K212535.

When did Nitrile Powder Free Blue Examination Gloves, Non-Sterile receive FDA 510(k) clearance?

Nitrile Powder Free Blue Examination Gloves, Non-Sterile received FDA 510(k) clearance on 2021-12-04, under 510(k) number K212535.

Who is the listed applicant for Nitrile Powder Free Blue Examination Gloves, Non-Sterile?

The FDA 510(k) record lists Mah Sing Healthcare Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nitrile Powder Free Blue Examination Gloves, Non-Sterile?

The FDA product code for Nitrile Powder Free Blue Examination Gloves, Non-Sterile is LZA.

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Other records listing Mah Sing Healthcare 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.

K243694Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - BlueK230002Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with Chemotherapy DrugsK223415Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl CitrateK214110Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs

Related Devices (Code: LZA)

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.

K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.K254285Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Aqua Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Violet Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Blue; Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs – Dark Violet BlueHartalega NGC Sdn. Bhd.K252117Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid SolutionSw Technologies, Inc.K253824Powder Free Nitrile Examination Gloves Non-Sterile BlackKanglongda Vietnam Protection Technology Company LimitedK260867Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black)Hartalega NGC Sdn. Bhd.K260806Nitrile Disposable Examination GlovesVista Industries,, LLC

Official Source

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