FDA 510(k)

POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIM, CONTAINS 50 MICROGRAMS OR LESS OF TOTA

K-Number: K001529 · 2000-06-12

ApplicantPerusahaan Getah Asas Sdn. Bhd.

Decision Date2000-06-12

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIM, CONTAINS 50 MICROGRAMS OR LESS OF TOTA is the device name listed in this FDA 510(k) record. The listed applicant is Perusahaan Getah Asas Sdn. Bhd.. It received FDA 510(k) clearance on 2000-06-12 under 510(k) number K001529. 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 POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIM, CONTAINS 50 MICROGRAMS OR LESS OF TOTA?

POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIM, CONTAINS 50 MICROGRAMS OR LESS OF TOTA is a medical device that received FDA 510(k) clearance on 2000-06-12. The listed applicant is Perusahaan Getah Asas Sdn. Bhd.. The 510(k) number is K001529.

When did POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIM, CONTAINS 50 MICROGRAMS OR LESS OF TOTA receive FDA 510(k) clearance?

POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIM, CONTAINS 50 MICROGRAMS OR LESS OF TOTA received FDA 510(k) clearance on 2000-06-12, under 510(k) number K001529.

Who is the listed applicant for POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIM, CONTAINS 50 MICROGRAMS OR LESS OF TOTA?

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

What is the FDA product code for POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIM, CONTAINS 50 MICROGRAMS OR LESS OF TOTA?

The FDA product code for POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE WITH PROTEIN LABELLING CLAIM, CONTAINS 50 MICROGRAMS OR LESS OF TOTA is LYY.

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Other records listing Perusahaan Getah Asas Sdn. Bhd. as applicant

K102790POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG K042805POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORED NON-STERILE K032374POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLORED K031625POWDER-FREE BARRIER-PRO CO-POLYMER EXAMINATION GLOVE, WHITE (NON-COLORED), AND GREEN COLORED K031768BARRIER-PRO CO-POLYMER PATIENT EXAMINATION GLOVE, POWDERED, WHITE (NON-COLORED) OR GREEN COLORED K031414POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), OR BLUE COLORED, WITH EXTRACTABLE PROTEIN CONTENT LABE

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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.