Name: Predicase
Price: 199 USD

K-number	K030331
Device name	ON-LINE POWDER-FREE LATEX EXAMINATION GLOVE, TYPE II,LOW MODULUS, WITH PROTEIN LABELING CLAIM
Applicant	Perusahaan Getah Asas Sdn. Bhd.
Product code	LYY
Device class	Class I
Decision date	Mar 21, 2003
Decision	Substantially Equivalent
Regulation	880.6250

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Source

View the full FDA submission: accessdata.fda.gov

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ON-LINE POWDER-FREE LATEX EXAMINATION GLOVE, TYPE II,LOW MODULUS, WITH PROTEIN LABELING CLAIM

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