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FDA 510(k)

SYNTHALON PI POWDER-FREE SYNTHETIC POLYISOPRENE/POLYCHLOROPRENE EXAMINATION GLOVES MDL 1362-10 TO 1362-44

K-Number: K060733 · 2006-04-24

ApplicantBarriermed, Inc.
Decision Date2006-04-24
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SYNTHALON PI POWDER-FREE SYNTHETIC POLYISOPRENE/POLYCHLOROPRENE EXAMINATION GLOVES MDL 1362-10 TO 1362-44 is the device name listed in this FDA 510(k) record. The listed applicant is Barriermed, Inc.. It received FDA 510(k) clearance on 2006-04-24 under 510(k) number K060733. 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 SYNTHALON PI POWDER-FREE SYNTHETIC POLYISOPRENE/POLYCHLOROPRENE EXAMINATION GLOVES MDL 1362-10 TO 1362-44?

SYNTHALON PI POWDER-FREE SYNTHETIC POLYISOPRENE/POLYCHLOROPRENE EXAMINATION GLOVES MDL 1362-10 TO 1362-44 is a medical device that received FDA 510(k) clearance on 2006-04-24. The listed applicant is Barriermed, Inc.. The 510(k) number is K060733.

When did SYNTHALON PI POWDER-FREE SYNTHETIC POLYISOPRENE/POLYCHLOROPRENE EXAMINATION GLOVES MDL 1362-10 TO 1362-44 receive FDA 510(k) clearance?

SYNTHALON PI POWDER-FREE SYNTHETIC POLYISOPRENE/POLYCHLOROPRENE EXAMINATION GLOVES MDL 1362-10 TO 1362-44 received FDA 510(k) clearance on 2006-04-24, under 510(k) number K060733.

Who is the listed applicant for SYNTHALON PI POWDER-FREE SYNTHETIC POLYISOPRENE/POLYCHLOROPRENE EXAMINATION GLOVES MDL 1362-10 TO 1362-44?

The FDA 510(k) record lists Barriermed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNTHALON PI POWDER-FREE SYNTHETIC POLYISOPRENE/POLYCHLOROPRENE EXAMINATION GLOVES MDL 1362-10 TO 1362-44?

The FDA product code for SYNTHALON PI POWDER-FREE SYNTHETIC POLYISOPRENE/POLYCHLOROPRENE EXAMINATION GLOVES MDL 1362-10 TO 1362-44 is LZA.

Related Clinical Trials

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.

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Other records listing Barriermed, Inc. 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.

K011446BARRIERPLUS POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVESK890974PATIENT EXAMINATION GLOVE

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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