FDA 510(k)

FLAVORED LATEX PATIENT EXAMINATION

K-Number: K960315 · 1996-11-20

Decision Date1996-11-20

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

FLAVORED LATEX PATIENT EXAMINATION is the device name listed in this FDA 510(k) record. The listed applicant is P.T. Irama Dinamika Latex. It received FDA 510(k) clearance on 1996-11-20 under 510(k) number K960315. 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 FLAVORED LATEX PATIENT EXAMINATION?

FLAVORED LATEX PATIENT EXAMINATION is a medical device that received FDA 510(k) clearance on 1996-11-20. The listed applicant is P.T. Irama Dinamika Latex. The 510(k) number is K960315.

When did FLAVORED LATEX PATIENT EXAMINATION receive FDA 510(k) clearance?

FLAVORED LATEX PATIENT EXAMINATION received FDA 510(k) clearance on 1996-11-20, under 510(k) number K960315.

Who is the listed applicant for FLAVORED LATEX PATIENT EXAMINATION?

The FDA 510(k) record lists P.T. Irama Dinamika Latex as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLAVORED LATEX PATIENT EXAMINATION?

The FDA product code for FLAVORED LATEX PATIENT EXAMINATION is LYY.

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Other records listing P.T. Irama Dinamika Latex as applicant

K984449NATURAL RUBBER PRE-POWDERED COLORED & FLAVORED PATIENT EXAMINATION GLOVES WITH PROTEIN LABELLING CLAIM K981064POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES K980848HYPOALLERGENIC LATEX PATIENT EXAM GLOVES-PREPOWDERED K972306POWDERFREE COLORED AND FLAVORED NITRILE COPOLYMER PATIENT EXAMINATION GLOVES-MEDICAL DEVICE K965155LATEX EXAM GLOVES K962518NITRILE COPOLYMER PATIENT EXAMINATION GLOVES

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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.