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FDA 510(k)

PATIENT EXAINATION GLOVES

K-Number: K945045 · 1995-01-02

ApplicantPhoenix Medical Technology, Inc.
Decision Date1995-01-02
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PATIENT EXAINATION 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 1995-01-02 under 510(k) number K945045. 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 PATIENT EXAINATION GLOVES?

PATIENT EXAINATION GLOVES is a medical device that received FDA 510(k) clearance on 1995-01-02. The listed applicant is Phoenix Medical Technology, Inc.. The 510(k) number is K945045.

When did PATIENT EXAINATION GLOVES receive FDA 510(k) clearance?

PATIENT EXAINATION GLOVES received FDA 510(k) clearance on 1995-01-02, under 510(k) number K945045.

Who is the listed applicant for PATIENT EXAINATION 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 PATIENT EXAINATION GLOVES?

The FDA product code for PATIENT EXAINATION GLOVES is LYY.

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Other records listing Phoenix Medical Technology, Inc. as applicant

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.

K000223NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREEK905031PATIENT EXAMINATION GLOVESK900454MODIFIED LOW POWDER SINGLE USE LATEX EXAM GLOVESK900453MODIFIED SINGLE USE LATEX EXAMINATION GLOVESK890917PHOENIX DRAPES WITH MICROBANK892976SINGLE USE VINYL EXAM GLOVES - COLOR CODED

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Related Devices (Code: LYY)

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.

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 LimitedK230573Powder 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 BhdK223298Sterile 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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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