Decision Date1999-01-25
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON COLORED) 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 1999-01-25 under 510(k) number K984605. The device is classified under product code LZA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON COLORED)?
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON COLORED) is a medical device that received FDA 510(k) clearance on 1999-01-25. The listed applicant is Perusahaan Getah Asas Sdn. Bhd.. The 510(k) number is K984605.
When did POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON COLORED) receive FDA 510(k) clearance?
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON COLORED) received FDA 510(k) clearance on 1999-01-25, under 510(k) number K984605.
Who is the listed applicant for POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON COLORED)?
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 POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON COLORED)?
The FDA product code for POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON COLORED) is LZA.
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Other records listing Perusahaan Getah Asas Sdn. Bhd. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
K102790POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUGK042805POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORED NON-STERILEK032374POWDER-FREE NITRILE PATIENT CHEMOTHERAPY EXAMINATION GLOVE, BLUE COLOREDK031625POWDER-FREE BARRIER-PRO CO-POLYMER EXAMINATION GLOVE, WHITE (NON-COLORED), AND GREEN COLOREDK031768BARRIER-PRO CO-POLYMER PATIENT EXAMINATION GLOVE, POWDERED, WHITE (NON-COLORED) OR GREEN COLOREDK031414POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), OR BLUE COLORED, WITH EXTRACTABLE PROTEIN CONTENT LABE View all 30 devices →
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.