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FDA 510(k)

NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING

K-Number: K070639 · 2007-06-15

ApplicantSiam Sempermed Corp., Ltd.
Decision Date2007-06-15
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING is the device name listed in this FDA 510(k) record. The listed applicant is Siam Sempermed Corp., Ltd.. It received FDA 510(k) clearance on 2007-06-15 under 510(k) number K070639. 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 NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING?

NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING is a medical device that received FDA 510(k) clearance on 2007-06-15. The listed applicant is Siam Sempermed Corp., Ltd.. The 510(k) number is K070639.

When did NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING receive FDA 510(k) clearance?

NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING received FDA 510(k) clearance on 2007-06-15, under 510(k) number K070639.

Who is the listed applicant for NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING?

The FDA 510(k) record lists Siam Sempermed Corp., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING?

The FDA product code for NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING is LZA.

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Other records listing Siam Sempermed Corp., 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.

K121549NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUEK122363NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUEK100907NON-STERILE, POWDER FREE LATEX EXAMINATION GLOVES AND PROTEIN CLAIM (50 MICROGRAMS OR LESS) MODEL: WHITE: X-SMALL, SMALLK082957NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE COLOR, POLYMER COATED, TESTED WITH CHEMOTHERAPY DRUGSK083755NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, LAVENDER BLUE COLOR, POLYMER COATED, TEXTED WITH CHEMOTHERAPY DRUGSK081911NON-STERILE, POWDERED 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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