510(k) K250502

Device
SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000)
Applicant
Safesource Direct, LLC
510(k) number
K250502
Product code
LZA
Decision
Substantially Equivalent (SESE)
Decision date
2025-03-19
Date received
2025-02-20
Regulation
880.6250
Classification name
Polymer Patient Examination Glove
Medical specialty
General Hospital
Review panel
General Hospital
Device class
1
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Courtney Cormier
Address
200 St. Nazaire Rd. Broussard LA US 70518 70518

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code LZA

510(k)DeviceApplicantDecision date
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K251716Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl CitrateBasic Medical Technology, Inc.2025-08-27
K252244Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acidEver Global (Vietnam) Enterprise Corporation2025-08-21
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K251319Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue); Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) – Extended CuffHartalega NGC Sdn. Bhd.2025-07-30
K250193Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue)Basic Medical Technology, Inc.2025-07-09
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