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FDA 510(k)

POWDER FREE NITRILE BLUE TEXTURED EXAMINATION GLOVE

K-Number: K052877 · 2005-11-08

ApplicantSyntex Healthcare Products Co., Ltd.
Decision Date2005-11-08
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

POWDER FREE NITRILE BLUE TEXTURED EXAMINATION GLOVE is the device name listed in this FDA 510(k) record. The listed applicant is Syntex Healthcare Products Co., Ltd.. It received FDA 510(k) clearance on 2005-11-08 under 510(k) number K052877. 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 POWDER FREE NITRILE BLUE TEXTURED EXAMINATION GLOVE?

POWDER FREE NITRILE BLUE TEXTURED EXAMINATION GLOVE is a medical device that received FDA 510(k) clearance on 2005-11-08. The listed applicant is Syntex Healthcare Products Co., Ltd.. The 510(k) number is K052877.

When did POWDER FREE NITRILE BLUE TEXTURED EXAMINATION GLOVE receive FDA 510(k) clearance?

POWDER FREE NITRILE BLUE TEXTURED EXAMINATION GLOVE received FDA 510(k) clearance on 2005-11-08, under 510(k) number K052877.

Who is the listed applicant for POWDER FREE NITRILE BLUE TEXTURED EXAMINATION GLOVE?

The FDA 510(k) record lists Syntex Healthcare Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for POWDER FREE NITRILE BLUE TEXTURED EXAMINATION GLOVE?

The FDA product code for POWDER FREE NITRILE BLUE TEXTURED EXAMINATION GLOVE is LZA.

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Other records listing Syntex Healthcare Products Co., Ltd. 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.

K240080Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl CitrateK231643Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)K103770SAME/VARIOUS DISTRIBUTORS/ WE MAY PRIVATE LABELK102096POWDER FREE NITRILE EXAMINATION GLOVES, BLUEK042226SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, TESTED FOR CHEMOTHERAPYK033777ULTRASENSE AF BLUE POWDER-FREE NITRILE EXAMINATION GLOVES

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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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