FDA 510(k)

POLYMER COATED, POWDER FREE LATEX EXAMINATION GLOVE (WHITE)

K-Number: K040792 · 2004-08-12

Decision Date2004-08-12

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

POLYMER COATED, POWDER FREE LATEX EXAMINATION GLOVE (WHITE) is the device name listed in this FDA 510(k) record. The listed applicant is Pt. Smartglove Indonesia. It received FDA 510(k) clearance on 2004-08-12 under 510(k) number K040792. 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 POLYMER COATED, POWDER FREE LATEX EXAMINATION GLOVE (WHITE)?

POLYMER COATED, POWDER FREE LATEX EXAMINATION GLOVE (WHITE) is a medical device that received FDA 510(k) clearance on 2004-08-12. The listed applicant is Pt. Smartglove Indonesia. The 510(k) number is K040792.

When did POLYMER COATED, POWDER FREE LATEX EXAMINATION GLOVE (WHITE) receive FDA 510(k) clearance?

POLYMER COATED, POWDER FREE LATEX EXAMINATION GLOVE (WHITE) received FDA 510(k) clearance on 2004-08-12, under 510(k) number K040792.

Who is the listed applicant for POLYMER COATED, POWDER FREE LATEX EXAMINATION GLOVE (WHITE)?

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

What is the FDA product code for POLYMER COATED, POWDER FREE LATEX EXAMINATION GLOVE (WHITE)?

The FDA product code for POLYMER COATED, POWDER FREE LATEX EXAMINATION GLOVE (WHITE) is LYY.

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Other records listing Pt. Smartglove Indonesia as applicant

K101630POWDER FREE NITRILE EXAMINATION GLOVES (6MIL), TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE K101293POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)K092034POWDER FREE NITRILE EXAMINATION GLOVES, BLACK K041848POLYMER COAT POWDER FREE NITRILE EXAMINATION GLOVES, GREEN AND WHITE COLOR K040791POLYMER COAT, POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)K030284POWDER FREE NITRILE EXAMINATION GLOVES (NATURAL, BLUE,PURPLE)

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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.