FDA 510(k)

LATEX POWDERED PATIENT EXAMINATION GLOVE, 200 MICROGRAMS OR LESS

K-Number: K011749 · 2001-08-22

Decision Date2001-08-22

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

LATEX POWDERED PATIENT EXAMINATION GLOVE, 200 MICROGRAMS OR LESS is the device name listed in this FDA 510(k) record. The listed applicant is Sempermed USA, Inc.. It received FDA 510(k) clearance on 2001-08-22 under 510(k) number K011749. 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 LATEX POWDERED PATIENT EXAMINATION GLOVE, 200 MICROGRAMS OR LESS?

LATEX POWDERED PATIENT EXAMINATION GLOVE, 200 MICROGRAMS OR LESS is a medical device that received FDA 510(k) clearance on 2001-08-22. The listed applicant is Sempermed USA, Inc.. The 510(k) number is K011749.

When did LATEX POWDERED PATIENT EXAMINATION GLOVE, 200 MICROGRAMS OR LESS receive FDA 510(k) clearance?

LATEX POWDERED PATIENT EXAMINATION GLOVE, 200 MICROGRAMS OR LESS received FDA 510(k) clearance on 2001-08-22, under 510(k) number K011749.

Who is the listed applicant for LATEX POWDERED PATIENT EXAMINATION GLOVE, 200 MICROGRAMS OR LESS?

The FDA 510(k) record lists Sempermed USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LATEX POWDERED PATIENT EXAMINATION GLOVE, 200 MICROGRAMS OR LESS?

The FDA product code for LATEX POWDERED PATIENT EXAMINATION GLOVE, 200 MICROGRAMS OR LESS is LYY.

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Other records listing Sempermed USA, Inc. as applicant

K011407LATEX POWDER-FREE EXAMINATION GLOVES BLUE, POLYMER COATED, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PRO

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.