FDA 510(k)

POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR

K-Number: K001674 · 2000-06-30

Decision Date2000-06-30

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR is the device name listed in this FDA 510(k) record. The listed applicant is Pamitex Industries Sdn Bhd. It received FDA 510(k) clearance on 2000-06-30 under 510(k) number K001674. 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 POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR?

POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR is a medical device that received FDA 510(k) clearance on 2000-06-30. The listed applicant is Pamitex Industries Sdn Bhd. The 510(k) number is K001674.

When did POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR receive FDA 510(k) clearance?

POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR received FDA 510(k) clearance on 2000-06-30, under 510(k) number K001674.

Who is the listed applicant for POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR?

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

What is the FDA product code for POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR?

The FDA product code for POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR is LYY.

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Other records listing Pamitex Industries Sdn Bhd as applicant

K003350HEALTH-PLUS, SANITEX, RELIANCE MULTIPLY POWDER FREE POLYMER AND NITRILE COATED (BLUE)K000952HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATION GLOVES - BLUE COLOR K001672POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVES K993756HEALTH-PLUS, SANITEX, RELIANCE STERILE POWDER-FREE NITRILE SURGICAL GLOVES K000828HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LAXTEX EXAMINATION GLOVE K993201HEALTH-PLUS, SANITEX, RELIANCE POWEDER-FREE STERILE LATEX SURGICAL 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.