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FDA 510(k)

NITRILE EXAMINATION GLOVES- PRE-POWDERED (SMALL, MEDIUM & LARGE)

K-Number: K980729 · 1998-04-02

ApplicantPt. Eka Wira Asia
Decision Date1998-04-02
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NITRILE EXAMINATION GLOVES- PRE-POWDERED (SMALL, MEDIUM & LARGE) is the device name listed in this FDA 510(k) record. The listed applicant is Pt. Eka Wira Asia. It received FDA 510(k) clearance on 1998-04-02 under 510(k) number K980729. 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 EXAMINATION GLOVES- PRE-POWDERED (SMALL, MEDIUM & LARGE)?

NITRILE EXAMINATION GLOVES- PRE-POWDERED (SMALL, MEDIUM & LARGE) is a medical device that received FDA 510(k) clearance on 1998-04-02. The listed applicant is Pt. Eka Wira Asia. The 510(k) number is K980729.

When did NITRILE EXAMINATION GLOVES- PRE-POWDERED (SMALL, MEDIUM & LARGE) receive FDA 510(k) clearance?

NITRILE EXAMINATION GLOVES- PRE-POWDERED (SMALL, MEDIUM & LARGE) received FDA 510(k) clearance on 1998-04-02, under 510(k) number K980729.

Who is the listed applicant for NITRILE EXAMINATION GLOVES- PRE-POWDERED (SMALL, MEDIUM & LARGE)?

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

What is the FDA product code for NITRILE EXAMINATION GLOVES- PRE-POWDERED (SMALL, MEDIUM & LARGE)?

The FDA product code for NITRILE EXAMINATION GLOVES- PRE-POWDERED (SMALL, MEDIUM & LARGE) 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 Pt. Eka Wira Asia 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.

K980807NITRILE EXAMNATION GLOVES- POWDERFREE (SMALL, MEDIUM AND LARGE)K941056LATEX EXAMINATION GLOVES, POWDER FREE

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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