Decision Date1998-09-30
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
NITRILE PATIENT EXAMINATION GLOVE 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 1998-09-30 under 510(k) number K982440. 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 NITRILE PATIENT EXAMINATION GLOVE?
NITRILE PATIENT EXAMINATION GLOVE is a medical device that received FDA 510(k) clearance on 1998-09-30. The listed applicant is Perusahaan Getah Asas Sdn. Bhd.. The 510(k) number is K982440.
When did NITRILE PATIENT EXAMINATION GLOVE receive FDA 510(k) clearance?
NITRILE PATIENT EXAMINATION GLOVE received FDA 510(k) clearance on 1998-09-30, under 510(k) number K982440.
Who is the listed applicant for NITRILE PATIENT EXAMINATION GLOVE?
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 NITRILE PATIENT EXAMINATION GLOVE?
The FDA product code for NITRILE PATIENT EXAMINATION GLOVE 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 COLOREDK031768BARRIER-PRO CO-POLYMER PATIENT EXAMINATION GLOVE, POWDERED, WHITE (NON-COLORED) OR GREEN COLOREDK031625POWDER-FREE BARRIER-PRO CO-POLYMER EXAMINATION GLOVE, WHITE (NON-COLORED), AND 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.