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FDA 510(k)

CASHMERE POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES

K-Number: K042238 · 2004-09-16

ApplicantSeal Polymer Industries Bhd.
Decision Date2004-09-16
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CASHMERE POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES is the device name listed in this FDA 510(k) record. The listed applicant is Seal Polymer Industries Bhd.. It received FDA 510(k) clearance on 2004-09-16 under 510(k) number K042238. 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 CASHMERE POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES?

CASHMERE POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES is a medical device that received FDA 510(k) clearance on 2004-09-16. The listed applicant is Seal Polymer Industries Bhd.. The 510(k) number is K042238.

When did CASHMERE POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES receive FDA 510(k) clearance?

CASHMERE POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES received FDA 510(k) clearance on 2004-09-16, under 510(k) number K042238.

Who is the listed applicant for CASHMERE POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES?

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

What is the FDA product code for CASHMERE POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES?

The FDA product code for CASHMERE POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES is LZA.

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Other records listing Seal Polymer Industries 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.

K042101CASHMERE POWDER FREE NITRILE EXAMINATION GLOVESK032077CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (VIOLET)K022792CASHMERE POWDER FREE LATEX EXAMINATION GLOVES (POLYMER COATED ONLINE CHLORINATED)K021388CASHMERE NON-STERILE, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRAMK020868CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (WHITE)K014055NON-STERILE POWDERED LATEX EXAMINATION GLOVES WITH A PROTEIN CLAIM ON LABELING

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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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