MULTISAFE POWDER FREE NITRILE GLOVES, NON STERILE (BLUE)— 510(k) K001619
Substantially EquivalentMultisafe Sdn. Bhd.
FDA 510(k) clearance K001619 for MULTISAFE POWDER FREE NITRILE GLOVES, NON STERILE (BLUE), Substantially Equivalent on 2000-07-26. Applicant: Multisafe Sdn. Bhd.. Device class: 1.
Clearance details
- Applicant
- Multisafe Sdn. Bhd.
- Product code
- Code LZA
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- 35500 Bidor, Perak Darul Ridzu, MY
Recent devices under product code LZA
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- K262542 — Biodegradable Nitrile Powder Free Examination Glove, Green +1 more
- K260312 — Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim +1 more
- K260794 — NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLOR
- K262014 — PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves
More clearances from Multisafe Sdn. Bhd.
view all- K161085 — Nitrile Patient Examination Powder Free Glove, Textured, Black
- K062526 — BLUE POWDERED LATEX EXAMINATION GLOVES, NON-STERILE
- K062527 — BLUE POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE
- K011293 — POWDER FREE POLYMER COATED LATEX MEDICAL EXAMINATION GLOVES, NON-STERILE W/ PROTEIN CONTENT LABELING CLAIM 50 MCG OR LES
- K001497 — MULTISAFE-POWDERED NITRILE GLOVES, NON-STERILE (BLUE)
Adverse events under product code LZA
product code LZA- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.