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FDA 510(k)

POWDERED LATEX PATIENT EXAMINATION GLOVES

K-Number: K051465 · 2005-07-12

ApplicantP.T. Anlis Abadi Internasional
Decision Date2005-07-12
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POWDERED LATEX PATIENT EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is P.T. Anlis Abadi Internasional. It received FDA 510(k) clearance on 2005-07-12 under 510(k) number K051465. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POWDERED LATEX PATIENT EXAMINATION GLOVES?

POWDERED LATEX PATIENT EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 2005-07-12. The listed applicant is P.T. Anlis Abadi Internasional. The 510(k) number is K051465.

When did POWDERED LATEX PATIENT EXAMINATION GLOVES receive FDA 510(k) clearance?

POWDERED LATEX PATIENT EXAMINATION GLOVES received FDA 510(k) clearance on 2005-07-12, under 510(k) number K051465.

Who is the listed applicant for POWDERED LATEX PATIENT EXAMINATION GLOVES?

The FDA 510(k) record lists P.T. Anlis Abadi Internasional as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWDERED LATEX PATIENT EXAMINATION GLOVES?

The FDA product code for POWDERED LATEX PATIENT EXAMINATION GLOVES is LYY.

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Related Devices (Code: LYY)

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.

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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.

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