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FDA 510(k)

Powder Free Chloroprene Examination Glove Coloured (Blue, Green)

K-Number: K213993 · 2022-08-05

Decision Date2022-08-05
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Powder Free Chloroprene Examination Glove Coloured (Blue, Green) is the device name listed in this FDA 510(k) record. The listed applicant is Careglove Global Sdn. Bhd.. It received FDA 510(k) clearance on 2022-08-05 under 510(k) number K213993. 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 Chloroprene Examination Glove Coloured (Blue, Green)?

Powder Free Chloroprene Examination Glove Coloured (Blue, Green) is a medical device that received FDA 510(k) clearance on 2022-08-05. The listed applicant is Careglove Global Sdn. Bhd.. The 510(k) number is K213993.

When did Powder Free Chloroprene Examination Glove Coloured (Blue, Green) receive FDA 510(k) clearance?

Powder Free Chloroprene Examination Glove Coloured (Blue, Green) received FDA 510(k) clearance on 2022-08-05, under 510(k) number K213993.

Who is the listed applicant for Powder Free Chloroprene Examination Glove Coloured (Blue, Green)?

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

What is the FDA product code for Powder Free Chloroprene Examination Glove Coloured (Blue, Green)?

The FDA product code for Powder Free Chloroprene Examination Glove Coloured (Blue, Green) is LZA.

Other records listing Careglove Global 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 8 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.