FDA 510(k)

LATEX PATIENT EXAMINATION (POWDERFREE GLOVE)

K-Number: K970794 · 1997-05-06

Decision Date1997-05-06

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

LATEX PATIENT EXAMINATION (POWDERFREE GLOVE) is the device name listed in this FDA 510(k) record. The listed applicant is Siam Sempermed Corp., Ltd.. It received FDA 510(k) clearance on 1997-05-06 under 510(k) number K970794. 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 PATIENT EXAMINATION (POWDERFREE GLOVE)?

LATEX PATIENT EXAMINATION (POWDERFREE GLOVE) is a medical device that received FDA 510(k) clearance on 1997-05-06. The listed applicant is Siam Sempermed Corp., Ltd.. The 510(k) number is K970794.

When did LATEX PATIENT EXAMINATION (POWDERFREE GLOVE) receive FDA 510(k) clearance?

LATEX PATIENT EXAMINATION (POWDERFREE GLOVE) received FDA 510(k) clearance on 1997-05-06, under 510(k) number K970794.

Who is the listed applicant for LATEX PATIENT EXAMINATION (POWDERFREE GLOVE)?

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

What is the FDA product code for LATEX PATIENT EXAMINATION (POWDERFREE GLOVE)?

The FDA product code for LATEX PATIENT EXAMINATION (POWDERFREE GLOVE) is LYY.

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Other records listing Siam Sempermed Corp., Ltd. as applicant

K121549NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE K122363NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE K100907NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) MODEL: WHITE: X-SMALL, SMALL K082957NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLOR, POLYMER COATED, TESTED WITH CHEMOTHERAPY DRUGS K083755NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, LAVENDER BLUE COLOR, POLYMER COATED, TEXTED WITH CHEMOTHERAPY DRUGS K081911NON-STERILE, POWDERED NITRILE EXAMINATION GLOVE, BLUE

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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.