FDA 510(k)

PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (180 UG/OR LESS)

K-Number: K021659 · 2002-08-12

Decision Date2002-08-12

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (180 UG/OR LESS) is the device name listed in this FDA 510(k) record. The listed applicant is P.T. Healthcare Glovindo. It received FDA 510(k) clearance on 2002-08-12 under 510(k) number K021659. 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 PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (180 UG/OR LESS)?

PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (180 UG/OR LESS) is a medical device that received FDA 510(k) clearance on 2002-08-12. The listed applicant is P.T. Healthcare Glovindo. The 510(k) number is K021659.

When did PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (180 UG/OR LESS) receive FDA 510(k) clearance?

PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (180 UG/OR LESS) received FDA 510(k) clearance on 2002-08-12, under 510(k) number K021659.

Who is the listed applicant for PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (180 UG/OR LESS)?

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

What is the FDA product code for PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (180 UG/OR LESS)?

The FDA product code for PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (180 UG/OR LESS) is LYY.

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Other records listing P.T. Healthcare Glovindo as applicant

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Related Devices (Code: LYY)

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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.