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FDA 510(k)

SBG Blue Nitrile Powder Free Medical Examination Glove

K-Number: K180467 · 2018-10-10

ApplicantShowa Best Glove, Inc.
Decision Date2018-10-10
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SBG Blue Nitrile Powder Free Medical Examination Glove is a medical device manufactured by Showa Best Glove, Inc.. It received FDA 510(k) clearance on 2018-10-10 under approval number K180467. 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 SBG Blue Nitrile Powder Free Medical Examination Glove?

SBG Blue Nitrile Powder Free Medical Examination Glove is a medical device that received FDA 510(k) clearance on 2018-10-10. It is manufactured by Showa Best Glove, Inc.. The 510(k) number is K180467.

When was SBG Blue Nitrile Powder Free Medical Examination Glove approved by the FDA?

SBG Blue Nitrile Powder Free Medical Examination Glove received FDA 510(k) clearance on 2018-10-10, under approval number K180467.

What company makes SBG Blue Nitrile Powder Free Medical Examination Glove?

SBG Blue Nitrile Powder Free Medical Examination Glove is manufactured by Showa Best Glove, Inc..

What is the FDA product code for SBG Blue Nitrile Powder Free Medical Examination Glove?

The FDA product code for SBG Blue Nitrile Powder Free Medical Examination Glove is LZA.

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Related PubMed Literature

PMID: 41398461 Evaluating commercial multimodal AI for diabetic eye screening and implications for an alternative regulatory pathway. NPJ digital medicine (2025)

Other Devices by Showa Best Glove, Inc.

K180468SBG Black Nitrile Powder Free Medical Examination Glove K190159Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove K211003SHOWA(R) Blue Nitrile Powder Free Medical Examination Glove

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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