FDA 510(k)

PREPOWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)

K-Number: K990502 · 1999-04-02

Decision Date1999-04-02

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

PREPOWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) is the device name listed in this FDA 510(k) record. The listed applicant is Flexitech Sdn. Bhd.. It received FDA 510(k) clearance on 1999-04-02 under 510(k) number K990502. 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 PREPOWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)?

PREPOWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) is a medical device that received FDA 510(k) clearance on 1999-04-02. The listed applicant is Flexitech Sdn. Bhd.. The 510(k) number is K990502.

When did PREPOWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) receive FDA 510(k) clearance?

PREPOWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) received FDA 510(k) clearance on 1999-04-02, under 510(k) number K990502.

Who is the listed applicant for PREPOWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)?

The FDA 510(k) record lists Flexitech Sdn. Bhd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PREPOWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)?

The FDA product code for PREPOWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS) is LYY.

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Other records listing Flexitech Sdn. Bhd. as applicant

K994416POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE K994354POLYMER COATED, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)K990501POWDER FREE LATEX EXAMINATION GLOVES, W/ PROTEIN LABELING CLAIM K990499PREPOWDERED NITRILE EXAMINATION GLOVES K990495POWDER FREE NITRILE EXAMINATION GLOVES

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.