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FDA 510(k)

Syntex Exam Gloves

K-Number: K253160 · 2026-01-23

ApplicantBasic Medical Technology, Inc.
Decision Date2026-01-23
Product CodeLZA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Syntex Exam Gloves is a medical device manufactured by Basic Medical Technology, Inc.. It received FDA 510(k) clearance on 2026-01-23 under approval number K253160. 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 Syntex Exam Gloves?

Syntex Exam Gloves is a medical device that received FDA 510(k) clearance on 2026-01-23. It is manufactured by Basic Medical Technology, Inc.. The 510(k) number is K253160.

When was Syntex Exam Gloves approved by the FDA?

Syntex Exam Gloves received FDA 510(k) clearance on 2026-01-23, under approval number K253160.

What company makes Syntex Exam Gloves?

Syntex Exam Gloves is manufactured by Basic Medical Technology, Inc..

What is the FDA product code for Syntex Exam Gloves?

The FDA product code for Syntex Exam Gloves is LZA.

Other Devices by Basic Medical Technology, Inc.

K252505Powder-Free Vinyl Exam Gloves, clear K251716Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate K250193Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue) K250630Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate K243792Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black,White) K243441Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue)

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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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