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FDA 510(k)

NON-STERILE POWDER- FREE PEACH COLOR, NITRILE EXAMINATION GLOVES WITH LANO-E AND PEPPERMINT CITRUS SCENT

K-Number: K101351 · 2010-10-15

ApplicantAscend Eagle, Inc.
Decision Date2010-10-15
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NON-STERILE POWDER- FREE PEACH COLOR, NITRILE EXAMINATION GLOVES WITH LANO-E AND PEPPERMINT CITRUS SCENT is the device name listed in this FDA 510(k) record. The listed applicant is Ascend Eagle, Inc.. It received FDA 510(k) clearance on 2010-10-15 under 510(k) number K101351. 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 NON-STERILE POWDER- FREE PEACH COLOR, NITRILE EXAMINATION GLOVES WITH LANO-E AND PEPPERMINT CITRUS SCENT?

NON-STERILE POWDER- FREE PEACH COLOR, NITRILE EXAMINATION GLOVES WITH LANO-E AND PEPPERMINT CITRUS SCENT is a medical device that received FDA 510(k) clearance on 2010-10-15. The listed applicant is Ascend Eagle, Inc.. The 510(k) number is K101351.

When did NON-STERILE POWDER- FREE PEACH COLOR, NITRILE EXAMINATION GLOVES WITH LANO-E AND PEPPERMINT CITRUS SCENT receive FDA 510(k) clearance?

NON-STERILE POWDER- FREE PEACH COLOR, NITRILE EXAMINATION GLOVES WITH LANO-E AND PEPPERMINT CITRUS SCENT received FDA 510(k) clearance on 2010-10-15, under 510(k) number K101351.

Who is the listed applicant for NON-STERILE POWDER- FREE PEACH COLOR, NITRILE EXAMINATION GLOVES WITH LANO-E AND PEPPERMINT CITRUS SCENT?

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

What is the FDA product code for NON-STERILE POWDER- FREE PEACH COLOR, NITRILE EXAMINATION GLOVES WITH LANO-E AND PEPPERMINT CITRUS SCENT?

The FDA product code for NON-STERILE POWDER- FREE PEACH COLOR, NITRILE EXAMINATION GLOVES WITH LANO-E AND PEPPERMINT CITRUS SCENT is LZA.

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Other records listing Ascend Eagle, 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.

K092472NON STERILE POWDER-FREE, NATURAL OR AQUA LANO-E NITRILE EXAMINATION GLOVES, WITH OR WITHOUT CITRUS/ PEPPERMINT SCENTK052666NON-STERILE POWDER FREE NATURAL/GREEN LANO-E LATEX EXAM GLOVES, WITH OR WIHOUT CITRUS/PEPPERMINT SCENT PLUS A PROTEIN

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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