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FDA 510(k)

Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile

K-Number: K231408 · 2023-08-11

ApplicantShandong Intco Medical Products Co, Ltd.
Decision Date2023-08-11
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile is a medical device manufactured by Shandong Intco Medical Products Co, Ltd.. It received FDA 510(k) clearance on 2023-08-11 under approval number K231408. 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 Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile?

Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile is a medical device that received FDA 510(k) clearance on 2023-08-11. It is manufactured by Shandong Intco Medical Products Co, Ltd.. The 510(k) number is K231408.

When was Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile approved by the FDA?

Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile received FDA 510(k) clearance on 2023-08-11, under approval number K231408.

What company makes Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile?

Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile is manufactured by Shandong Intco Medical Products Co, Ltd..

What is the FDA product code for Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile?

The FDA product code for Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile is LZA.

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Other Devices by Shandong Intco Medical Products Co, Ltd.

K213509Latex Examination Gloves, Powder Free K233042Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K223298Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L)

Related Devices (Code: LZA)

K161215Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy DrugsBrightway Holdings Sdn. Bhd. K161932Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove PinkTerang Nusa Sdn Bhd K161944Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy DrugsShandong Baisheng Medical Products Co., Ltd. K161074Powder Free Nitrile Examination Gloves Flock-Lined, Black ColorShen Wei (Usa), Inc. K162113Powder Free Nitrile Examination Gloves (Blue)Nam Viet Glove Joint Stock Company K162095Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)Yty Industry (Manjung) Sdn Bhd

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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