FDA 510(k)

MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE

K-Number: K963560 · 1996-10-24

Decision Date1996-10-24

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE is the device name listed in this FDA 510(k) record. The listed applicant is Pwa Industries Sdn. Bhd.. It received FDA 510(k) clearance on 1996-10-24 under 510(k) number K963560. 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 MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE?

MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE is a medical device that received FDA 510(k) clearance on 1996-10-24. The listed applicant is Pwa Industries Sdn. Bhd.. The 510(k) number is K963560.

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

MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE received FDA 510(k) clearance on 1996-10-24, under 510(k) number K963560.

Who is the listed applicant for MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE?

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

What is the FDA product code for MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE?

The FDA product code for MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE is LYY.

Related Clinical Trials

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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Other records listing Pwa Industries Sdn. Bhd. as applicant

K011895POWDER-FREE MULTI-PLY LATEX EXAMINATION GLOVES, POLYMER COATED ON OUTSIDE AND NITRILE COATED ON INSIDE, BLUE COLOR WITH K010077HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVES K001475HEALTH-PLUS, SANITEX, RELIANCE, POWDERED LATEX EXAM GLOVES CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PR K001485HEALTH-PLUS, SANITEX, RELIANCE, POWDER-FREE LATEX EXAMINATION GLOVES K981774MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE K973913MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE

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Related Devices (Code: LYY)

K250069Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less ProteinComfort Rubber Gloves Industries Sdn. Bhd.K240266Latex Examination Glove Powder Free (Ocean Blue and Natural White)Sri Trang Gloves (Thailand) Public Company Limited K230573Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)Kossan International Sdn Bhd K223298Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)Shandong Intco Medical Products Co, Ltd.K222612Powder-Free Latex examination glovesGuangdong Kingfa Sci. & Tech.Co., Ltd.K221667Non Sterile Powder Free Latex Examination GloveNew Era Medicare Sdn. Bhd.

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.