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FDA 510(k)

GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, BLUE, NON-STERILE CONTAINS 50 MCGIN OR LESS OF TOTAL WATER EXTRACTABLE PR

K-Number: K032007 · 2003-07-28

ApplicantPt. Wrp Buana Multicorpora
Decision Date2003-07-28
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, BLUE, NON-STERILE CONTAINS 50 MCGIN OR LESS OF TOTAL WATER EXTRACTABLE PR 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 2003-07-28 under 510(k) number K032007. 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 POWDER FREE LATEX EXAMINATION GLOVES, BLUE, NON-STERILE CONTAINS 50 MCGIN OR LESS OF TOTAL WATER EXTRACTABLE PR?

GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, BLUE, NON-STERILE CONTAINS 50 MCGIN OR LESS OF TOTAL WATER EXTRACTABLE PR is a medical device that received FDA 510(k) clearance on 2003-07-28. The listed applicant is Pt. Wrp Buana Multicorpora. The 510(k) number is K032007.

When did GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, BLUE, NON-STERILE CONTAINS 50 MCGIN OR LESS OF TOTAL WATER EXTRACTABLE PR receive FDA 510(k) clearance?

GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, BLUE, NON-STERILE CONTAINS 50 MCGIN OR LESS OF TOTAL WATER EXTRACTABLE PR received FDA 510(k) clearance on 2003-07-28, under 510(k) number K032007.

Who is the listed applicant for GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, BLUE, NON-STERILE CONTAINS 50 MCGIN OR LESS OF TOTAL WATER EXTRACTABLE PR?

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 POWDER FREE LATEX EXAMINATION GLOVES, BLUE, NON-STERILE CONTAINS 50 MCGIN OR LESS OF TOTAL WATER EXTRACTABLE PR?

The FDA product code for GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, BLUE, NON-STERILE CONTAINS 50 MCGIN OR LESS OF TOTAL WATER EXTRACTABLE PR is LYY.

Related Clinical Trials

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Other records listing Pt. Wrp Buana Multicorpora 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.

K032010GLOVETEX POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, NON-STERILEK032011GLOVETEX POWDER FREE WHITE NITRILE EXAMINATION GLOVES, NON-STERILEK030273GLOVETEX LATEX EXAMINATION GLOVES, POWDERED, BLUE, NON STERILEK022343GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE (PROTEIN CONTENT LABELING CLAIM 50UG/G OR LESS)K994426GLOVETEX, LATEX EXAMINATION GLOVES, POWDERED NON-STERILE.(PROTEIN CONTENT LABELING)

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

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

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