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FDA 510(k)

NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING, MODEL BLUE: ALL SIZES (XS-XL)

K-Number: K060753 · 2006-04-27

ApplicantSiam Sempermed Corp., Ltd.
Decision Date2006-04-27
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING, MODEL BLUE: ALL SIZES (XS-XL) 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 2006-04-27 under 510(k) number K060753. 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, MODEL BLUE: ALL SIZES (XS-XL)?

NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING, MODEL BLUE: ALL SIZES (XS-XL) is a medical device that received FDA 510(k) clearance on 2006-04-27. The listed applicant is Siam Sempermed Corp., Ltd.. The 510(k) number is K060753.

When did NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING, MODEL BLUE: ALL SIZES (XS-XL) receive FDA 510(k) clearance?

NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING, MODEL BLUE: ALL SIZES (XS-XL) received FDA 510(k) clearance on 2006-04-27, under 510(k) number K060753.

Who is the listed applicant for NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING, MODEL BLUE: ALL SIZES (XS-XL)?

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, MODEL BLUE: ALL SIZES (XS-XL)?

The FDA product code for NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE WITH POLYMER COATING, MODEL BLUE: ALL SIZES (XS-XL) 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.

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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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