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FDA 510(k)

ARSOFT NITRILE EXAMINATION GLOVES, NON-STERILE POWDER FREE

K-Number: K990427 · 1999-04-23

ApplicantAlliance Rubber Products Sdn. Bhd.
Decision Date1999-04-23
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ARSOFT NITRILE EXAMINATION GLOVES, NON-STERILE POWDER FREE is the device name listed in this FDA 510(k) record. The listed applicant is Alliance Rubber Products Sdn. Bhd.. It received FDA 510(k) clearance on 1999-04-23 under 510(k) number K990427. 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 ARSOFT NITRILE EXAMINATION GLOVES, NON-STERILE POWDER FREE?

ARSOFT NITRILE EXAMINATION GLOVES, NON-STERILE POWDER FREE is a medical device that received FDA 510(k) clearance on 1999-04-23. The listed applicant is Alliance Rubber Products Sdn. Bhd.. The 510(k) number is K990427.

When did ARSOFT NITRILE EXAMINATION GLOVES, NON-STERILE POWDER FREE receive FDA 510(k) clearance?

ARSOFT NITRILE EXAMINATION GLOVES, NON-STERILE POWDER FREE received FDA 510(k) clearance on 1999-04-23, under 510(k) number K990427.

Who is the listed applicant for ARSOFT NITRILE EXAMINATION GLOVES, NON-STERILE POWDER FREE?

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

What is the FDA product code for ARSOFT NITRILE EXAMINATION GLOVES, NON-STERILE POWDER FREE?

The FDA product code for ARSOFT NITRILE EXAMINATION GLOVES, NON-STERILE POWDER FREE is LZA.

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Other records listing Alliance Rubber Products 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.

K002701POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN LABELING CLAIM. (50 MICROGRAMS OR LESS)K992870POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES LABELING CONTENT: 100 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIK991981NITRILE EXAMINATION GLOVES, NON-STERILE, POWDER FREE, DARK BLUE COLORK990486NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, BLUE COLOR.K990485NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, GREEN COLORK990453NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN COLOR

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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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