Name: Predicase
Price: 199 USD

K-number	K250861
Device name	Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black)
Applicant	Hartalega NGC Sdn. Bhd.
Product code	LZA
Device class	Class I
Decision date	Oct 23, 2025
Decision	Substantially Equivalent
Regulation	880.6250

AI Summary

The FDA summary PDF for this submission is not available in machine-readable form — common for older clearances. View on FDA's site →

Source

View the full FDA submission: accessdata.fda.gov

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Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black)

Everything you need for a 510(k) submission. Nothing you don't.