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FDA 510(k)

HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVE

K-Number: K992223 · 1999-08-30

ApplicantPamitex Industries Sdn Bhd
Decision Date1999-08-30
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Pamitex Industries Sdn Bhd. It received FDA 510(k) clearance on 1999-08-30 under 510(k) number K992223. 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 HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVE?

HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVE is a medical device that received FDA 510(k) clearance on 1999-08-30. The listed applicant is Pamitex Industries Sdn Bhd. The 510(k) number is K992223.

When did HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVE receive FDA 510(k) clearance?

HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVE received FDA 510(k) clearance on 1999-08-30, under 510(k) number K992223.

Who is the listed applicant for HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVE?

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

What is the FDA product code for HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVE?

The FDA product code for HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE NITRILE EXAMINATION GLOVE is LZA.

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Other records listing Pamitex Industries 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.

K003350HEALTH-PLUS, SANITEX, RELIANCE MULTIPLY POWDER FREE POLYMER AND NITRILE COATED (BLUE)K000952HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATION GLOVES - BLUE COLORK001674POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLORK001672POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVESK993756HEALTH-PLUS, SANITEX, RELIANCE STERILE POWDER-FREE NITRILE SURGICAL GLOVESK000828HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LAXTEX EXAMINATION GLOVE

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Related Devices (Code: LZA)

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.

K261793Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)Maxter Healthcare, Inc.K262542Biodegradable Nitrile Powder Free Examination Glove, Green; Biodegradable Nitrile Powder Free Examination Glove, Violet Blue Tested for Use With 32 Chemotherapy Drugs, Fentanyl & Gastric Acid Permeation Resistance ClaimTop Glove Sdn. Bhd.K260312Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim; Nitrile Powder Free Examination Glove, Violet Blue Tested for Use with 32 Chemotherapy Drugs, Xylazine, Fentanyl & Gastric AcidGmp Medicare Sdn. Bhd.K261749Cardinal Health Nitrile Blue Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl CitrateCardinalhealthK260794NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLORKossan International Sdn BhdK262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.

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.

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