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FDA 510(k)

NITRILE POWDER FREE EXAM GLOVE, WITH PEPPERMINT FLAVOR

K-Number: K030406 · 2003-02-27

ApplicantPt. Smartglove Indonesia
Decision Date2003-02-27
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NITRILE POWDER FREE EXAM GLOVE, WITH PEPPERMINT FLAVOR is the device name listed in this FDA 510(k) record. The listed applicant is Pt. Smartglove Indonesia. It received FDA 510(k) clearance on 2003-02-27 under 510(k) number K030406. 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 NITRILE POWDER FREE EXAM GLOVE, WITH PEPPERMINT FLAVOR?

NITRILE POWDER FREE EXAM GLOVE, WITH PEPPERMINT FLAVOR is a medical device that received FDA 510(k) clearance on 2003-02-27. The listed applicant is Pt. Smartglove Indonesia. The 510(k) number is K030406.

When did NITRILE POWDER FREE EXAM GLOVE, WITH PEPPERMINT FLAVOR receive FDA 510(k) clearance?

NITRILE POWDER FREE EXAM GLOVE, WITH PEPPERMINT FLAVOR received FDA 510(k) clearance on 2003-02-27, under 510(k) number K030406.

Who is the listed applicant for NITRILE POWDER FREE EXAM GLOVE, WITH PEPPERMINT FLAVOR?

The FDA 510(k) record lists Pt. Smartglove Indonesia as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NITRILE POWDER FREE EXAM GLOVE, WITH PEPPERMINT FLAVOR?

The FDA product code for NITRILE POWDER FREE EXAM GLOVE, WITH PEPPERMINT FLAVOR is LZA.

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Other records listing Pt. Smartglove Indonesia 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.

K101630POWDER FREE NITRILE EXAMINATION GLOVES (6MIL), TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUEK101293POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS (BLUE)K092034POWDER FREE NITRILE EXAMINATION GLOVES, BLACKK041848POLYMER COAT POWDER FREE NITRILE EXAMINATION GLOVES, GREEN AND WHITE COLORK040792POLYMER COATED, POWDER FREE LATEX EXAMINATION GLOVE (WHITE)K040791POLYMER COAT, POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)

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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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