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FDA 510(k)

Patient Examination Gloves

K-Number: K230777 · 2023-10-06

Decision Date2023-10-06
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Patient Examination Gloves is the device name listed in this FDA 510(k) record. The listed applicant is 3A Glove Sdn. Bhd.. It received FDA 510(k) clearance on 2023-10-06 under 510(k) number K230777. 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 Patient Examination Gloves?

Patient Examination Gloves is a medical device that received FDA 510(k) clearance on 2023-10-06. The listed applicant is 3A Glove Sdn. Bhd.. The 510(k) number is K230777.

When did Patient Examination Gloves receive FDA 510(k) clearance?

Patient Examination Gloves received FDA 510(k) clearance on 2023-10-06, under 510(k) number K230777.

Who is the listed applicant for Patient Examination Gloves?

The FDA 510(k) record lists 3A Glove Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Patient Examination Gloves?

The FDA product code for Patient Examination Gloves is LZA.

Other records listing 3A Glove 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.

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.