FDA 510(k)

STERILE LATEX EXAMINATION GLOVES (POWDERED) WITH PROTEIN CLAIM LESS THAN 100UG/G

K-Number: K012856 · 2001-11-16

Decision Date2001-11-16

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

STERILE LATEX EXAMINATION GLOVES (POWDERED) WITH PROTEIN CLAIM LESS THAN 100UG/G is the device name listed in this FDA 510(k) record. The listed applicant is Smart Glove Corp. Sdn Bhd. It received FDA 510(k) clearance on 2001-11-16 under 510(k) number K012856. 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 STERILE LATEX EXAMINATION GLOVES (POWDERED) WITH PROTEIN CLAIM LESS THAN 100UG/G?

STERILE LATEX EXAMINATION GLOVES (POWDERED) WITH PROTEIN CLAIM LESS THAN 100UG/G is a medical device that received FDA 510(k) clearance on 2001-11-16. The listed applicant is Smart Glove Corp. Sdn Bhd. The 510(k) number is K012856.

When did STERILE LATEX EXAMINATION GLOVES (POWDERED) WITH PROTEIN CLAIM LESS THAN 100UG/G receive FDA 510(k) clearance?

STERILE LATEX EXAMINATION GLOVES (POWDERED) WITH PROTEIN CLAIM LESS THAN 100UG/G received FDA 510(k) clearance on 2001-11-16, under 510(k) number K012856.

Who is the listed applicant for STERILE LATEX EXAMINATION GLOVES (POWDERED) WITH PROTEIN CLAIM LESS THAN 100UG/G?

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

What is the FDA product code for STERILE LATEX EXAMINATION GLOVES (POWDERED) WITH PROTEIN CLAIM LESS THAN 100UG/G?

The FDA product code for STERILE LATEX EXAMINATION GLOVES (POWDERED) WITH PROTEIN CLAIM LESS THAN 100UG/G is LYY.

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Other records listing Smart Glove Corp. Sdn Bhd as applicant

K091147POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)K082370POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)K081466STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE K071170POWDER FREE NITRILE EXAMINATION GLOVES, MAGENTA AND WHITE COLOR COATED WITH ALLOGEL K063627POWDER FREE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)K061724POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED (BLUE AND WHITE)

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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.