FDA 510(k)

PRE-POWDERED NITRILE EXAMINATION GLOVES

K-Number: K010232 · 2001-09-21

Decision Date2001-09-21

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

PRE-POWDERED NITRILE EXAMINATION GLOVES 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 2001-09-21 under 510(k) number K010232. 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 PRE-POWDERED NITRILE EXAMINATION GLOVES?

PRE-POWDERED NITRILE EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 2001-09-21. The listed applicant is P.T. Healthcare Glovindo. The 510(k) number is K010232.

When did PRE-POWDERED NITRILE EXAMINATION GLOVES receive FDA 510(k) clearance?

PRE-POWDERED NITRILE EXAMINATION GLOVES received FDA 510(k) clearance on 2001-09-21, under 510(k) number K010232.

Who is the listed applicant for PRE-POWDERED NITRILE EXAMINATION GLOVES?

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 NITRILE EXAMINATION GLOVES?

The FDA product code for PRE-POWDERED NITRILE EXAMINATION GLOVES is LZA.

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Other records listing P.T. Healthcare Glovindo as applicant

K021659PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (180 UG/OR LESS)K010233POWDER FREE NITRILE EXAMINATION GLOVES K000838DIGITCARE POWDER FREE COATED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)K974853LATEX (POWDER FREE) LOW PROTEIN K931406POWDER-FREE PATIENT EXAMINATION GLOVES K930995POWDERED EXAMINATION GLOVES

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Related Devices (Code: LZA)

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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.