FDA 510(k)

HEALTH-PLUS, SANITEX, RELIANCE (50 MICROGRAMS)

K-Number: K993093 · 1999-10-29

Decision Date1999-10-29

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

HEALTH-PLUS, SANITEX, RELIANCE (50 MICROGRAMS) is the device name listed in this FDA 510(k) record. The listed applicant is Pamitex Industries Sdn Bhd. It received FDA 510(k) clearance on 1999-10-29 under 510(k) number K993093. 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 HEALTH-PLUS, SANITEX, RELIANCE (50 MICROGRAMS)?

HEALTH-PLUS, SANITEX, RELIANCE (50 MICROGRAMS) is a medical device that received FDA 510(k) clearance on 1999-10-29. The listed applicant is Pamitex Industries Sdn Bhd. The 510(k) number is K993093.

When did HEALTH-PLUS, SANITEX, RELIANCE (50 MICROGRAMS) receive FDA 510(k) clearance?

HEALTH-PLUS, SANITEX, RELIANCE (50 MICROGRAMS) received FDA 510(k) clearance on 1999-10-29, under 510(k) number K993093.

Who is the listed applicant for HEALTH-PLUS, SANITEX, RELIANCE (50 MICROGRAMS)?

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

What is the FDA product code for HEALTH-PLUS, SANITEX, RELIANCE (50 MICROGRAMS)?

The FDA product code for HEALTH-PLUS, SANITEX, RELIANCE (50 MICROGRAMS) is LYY.

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Other records listing Pamitex Industries Sdn Bhd as applicant

K003350HEALTH-PLUS, SANITEX, RELIANCE MULTIPLY POWDER FREE POLYMER AND NITRILE COATED (BLUE)K000952HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATION GLOVES - BLUE COLOR K001674POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR K001672POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVES K993756HEALTH-PLUS, SANITEX, RELIANCE STERILE POWDER-FREE NITRILE SURGICAL GLOVES K000828HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LAXTEX EXAMINATION GLOVE

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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.