FDA 510(k)

LATEX PATIENT EXAMINATION GLOVE POWDERFREE LAMINATED COPOLYMER

K-Number: K951018 · 1995-08-28

Decision Date1995-08-28

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

LATEX PATIENT EXAMINATION GLOVE POWDERFREE LAMINATED COPOLYMER 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 1995-08-28 under 510(k) number K951018. 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 GLOVE POWDERFREE LAMINATED COPOLYMER?

LATEX PATIENT EXAMINATION GLOVE POWDERFREE LAMINATED COPOLYMER is a medical device that received FDA 510(k) clearance on 1995-08-28. The listed applicant is Siam Sempermed Corp., Ltd.. The 510(k) number is K951018.

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

LATEX PATIENT EXAMINATION GLOVE POWDERFREE LAMINATED COPOLYMER received FDA 510(k) clearance on 1995-08-28, under 510(k) number K951018.

Who is the listed applicant for LATEX PATIENT EXAMINATION GLOVE POWDERFREE LAMINATED COPOLYMER?

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 GLOVE POWDERFREE LAMINATED COPOLYMER?

The FDA product code for LATEX PATIENT EXAMINATION GLOVE POWDERFREE LAMINATED COPOLYMER 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)

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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.