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FDA 510(k)

Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)

K-Number: K203036 · 2021-05-07

Decision Date2021-05-07
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors) 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 2021-05-07 under 510(k) number K203036. 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 Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)?

Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors) is a medical device that received FDA 510(k) clearance on 2021-05-07. The listed applicant is Central Medicare Sdn Bhd. The 510(k) number is K203036.

When did Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors) receive FDA 510(k) clearance?

Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors) received FDA 510(k) clearance on 2021-05-07, under 510(k) number K203036.

Who is the listed applicant for Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)?

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 Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)?

The FDA product code for Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors) is LZA.

Related Clinical Trials

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.

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.

View all 11 devices →

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.