FDA 510(k)

NITRILON CORRECT-TOUCH

K-Number: K981333 · 1998-06-22

Decision Date1998-06-22

Product CodeLZA

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

NITRILON CORRECT-TOUCH is the device name listed in this FDA 510(k) record. The listed applicant is Biopro (M) Sdn Bhd. It received FDA 510(k) clearance on 1998-06-22 under 510(k) number K981333. 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 NITRILON CORRECT-TOUCH?

NITRILON CORRECT-TOUCH is a medical device that received FDA 510(k) clearance on 1998-06-22. The listed applicant is Biopro (M) Sdn Bhd. The 510(k) number is K981333.

When did NITRILON CORRECT-TOUCH receive FDA 510(k) clearance?

NITRILON CORRECT-TOUCH received FDA 510(k) clearance on 1998-06-22, under 510(k) number K981333.

Who is the listed applicant for NITRILON CORRECT-TOUCH?

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

What is the FDA product code for NITRILON CORRECT-TOUCH?

The FDA product code for NITRILON CORRECT-TOUCH is LZA.

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Other records listing Biopro (M) Sdn Bhd as applicant

K994281BIOPRO, NITRILE, CORRECT TOUCH NITRILE POWDER FREE EXAMINATION GLOVES (GRREN, PURPLE)K994276BIOPRO, NITRILON, CORRECT TOUCH- NITRILE POWDERED EXAMINATION GLOVES (GREEN/ PURPLE)K994043CORRECT TOUCH LATEX POWDERED EXAMINATION GLOVES K992358CORRECT TOUCH POWDER FREE 911 LATEX EXAMINATION GLOVES, (BLUE)

Related Devices (Code: LZA)

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 CitrateCardinalhealth K260794NON-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 Bhd K262014PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam GlovesO&M Halyard, Inc.

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.