Decision Date2001-04-10
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, PURPLE COLOR 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 2001-04-10 under 510(k) number K010719. 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, PURPLE COLOR?
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, PURPLE COLOR is a medical device that received FDA 510(k) clearance on 2001-04-10. The listed applicant is Perusahaan Getah Asas Sdn. Bhd.. The 510(k) number is K010719.
When did POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, PURPLE COLOR receive FDA 510(k) clearance?
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, PURPLE COLOR received FDA 510(k) clearance on 2001-04-10, under 510(k) number K010719.
Who is the listed applicant for POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, PURPLE COLOR?
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, PURPLE COLOR?
The FDA product code for POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, PURPLE COLOR 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.
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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.