FDA 510(k)

LATEX (POWDER FREE) LOW PROTEIN

K-Number: K974853 · 1998-02-09

Decision Date1998-02-09

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

LATEX (POWDER FREE) LOW PROTEIN 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 1998-02-09 under 510(k) number K974853. 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 LATEX (POWDER FREE) LOW PROTEIN?

LATEX (POWDER FREE) LOW PROTEIN is a medical device that received FDA 510(k) clearance on 1998-02-09. The listed applicant is P.T. Healthcare Glovindo. The 510(k) number is K974853.

When did LATEX (POWDER FREE) LOW PROTEIN receive FDA 510(k) clearance?

LATEX (POWDER FREE) LOW PROTEIN received FDA 510(k) clearance on 1998-02-09, under 510(k) number K974853.

Who is the listed applicant for LATEX (POWDER FREE) LOW PROTEIN?

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 LATEX (POWDER FREE) LOW PROTEIN?

The FDA product code for LATEX (POWDER FREE) LOW PROTEIN is LYY.

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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)K010232PRE-POWDERED NITRILE EXAMINATION GLOVES K010233POWDER FREE NITRILE EXAMINATION GLOVES K000838DIGITCARE POWDER FREE COATED EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)K931406POWDER-FREE PATIENT EXAMINATION GLOVES K930995POWDERED EXAMINATION GLOVES

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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.