FDA 510(k)

GLOVETEX, LATEX EXAMINATION GLOVES, POWDERED NON-STERILE.(PROTEIN CONTENT LABELING)

K-Number: K994426 · 2000-05-23

Decision Date2000-05-23

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

GLOVETEX, LATEX EXAMINATION GLOVES, POWDERED NON-STERILE.(PROTEIN CONTENT LABELING) is the device name listed in this FDA 510(k) record. The listed applicant is Pt. Wrp Buana Multicorpora. It received FDA 510(k) clearance on 2000-05-23 under 510(k) number K994426. 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 GLOVETEX, LATEX EXAMINATION GLOVES, POWDERED NON-STERILE.(PROTEIN CONTENT LABELING)?

GLOVETEX, LATEX EXAMINATION GLOVES, POWDERED NON-STERILE.(PROTEIN CONTENT LABELING) is a medical device that received FDA 510(k) clearance on 2000-05-23. The listed applicant is Pt. Wrp Buana Multicorpora. The 510(k) number is K994426.

When did GLOVETEX, LATEX EXAMINATION GLOVES, POWDERED NON-STERILE.(PROTEIN CONTENT LABELING) receive FDA 510(k) clearance?

GLOVETEX, LATEX EXAMINATION GLOVES, POWDERED NON-STERILE.(PROTEIN CONTENT LABELING) received FDA 510(k) clearance on 2000-05-23, under 510(k) number K994426.

Who is the listed applicant for GLOVETEX, LATEX EXAMINATION GLOVES, POWDERED NON-STERILE.(PROTEIN CONTENT LABELING)?

The FDA 510(k) record lists Pt. Wrp Buana Multicorpora as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLOVETEX, LATEX EXAMINATION GLOVES, POWDERED NON-STERILE.(PROTEIN CONTENT LABELING)?

The FDA product code for GLOVETEX, LATEX EXAMINATION GLOVES, POWDERED NON-STERILE.(PROTEIN CONTENT LABELING) is LYY.

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Other records listing Pt. Wrp Buana Multicorpora as applicant

K032010GLOVETEX POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, NON-STERILE K032011GLOVETEX POWDER FREE WHITE NITRILE EXAMINATION GLOVES, NON-STERILE K032007GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, BLUE, NON-STERILE CONTAINS 50 MCGIN OR LESS OF TOTAL WATER EXTRACTABLE PR K030273GLOVETEX LATEX EXAMINATION GLOVES, POWDERED, BLUE, NON STERILE K022343GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE (PROTEIN CONTENT LABELING CLAIM 50UG/G OR LESS)

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.