FDA 510(k)

MODIFIED LOW POWDER SINGLE USE LATEX EXAM GLOVES

K-Number: K900454 · 1990-02-13

ApplicantPhoenix Medical Technology, Inc.

Decision Date1990-02-13

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

MODIFIED LOW POWDER SINGLE USE LATEX EXAM GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Phoenix Medical Technology, Inc.. It received FDA 510(k) clearance on 1990-02-13 under 510(k) number K900454. 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 MODIFIED LOW POWDER SINGLE USE LATEX EXAM GLOVES?

MODIFIED LOW POWDER SINGLE USE LATEX EXAM GLOVES is a medical device that received FDA 510(k) clearance on 1990-02-13. The listed applicant is Phoenix Medical Technology, Inc.. The 510(k) number is K900454.

When did MODIFIED LOW POWDER SINGLE USE LATEX EXAM GLOVES receive FDA 510(k) clearance?

MODIFIED LOW POWDER SINGLE USE LATEX EXAM GLOVES received FDA 510(k) clearance on 1990-02-13, under 510(k) number K900454.

Who is the listed applicant for MODIFIED LOW POWDER SINGLE USE LATEX EXAM GLOVES?

The FDA 510(k) record lists Phoenix Medical Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFIED LOW POWDER SINGLE USE LATEX EXAM GLOVES?

The FDA product code for MODIFIED LOW POWDER SINGLE USE LATEX EXAM GLOVES is LYY.

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Other records listing Phoenix Medical Technology, Inc. as applicant

K000223NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE K945045PATIENT EXAINATION GLOVES K905031PATIENT EXAMINATION GLOVES K900453MODIFIED SINGLE USE LATEX EXAMINATION GLOVES K890917PHOENIX DRAPES WITH MICROBAN K892976SINGLE USE VINYL EXAM GLOVES - COLOR CODED

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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.