POWDERED NITRILE EXAMINATION GLOVES (BLUE,WHITE)— 510(k) K050531
Substantially EquivalentSpi Gloves Sdn. Bhd.
FDA 510(k) clearance K050531 for POWDERED NITRILE EXAMINATION GLOVES (BLUE,WHITE), Substantially Equivalent on 2005-03-18. Applicant: Spi Gloves Sdn. Bhd.. Device class: 1.
Clearance details
- Applicant
- Spi Gloves 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
- Ipoh 30450, 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 Spi Gloves Sdn. Bhd.
view all- K050526 — POLYMER COATED ONLINE CHLORINATED POWDER FREE EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR
- K050528 — POWDER FREE NITRILE EXAMINATION GLOVES (BLUE,WHITE,VIOLET,PINK,GREEN,BLACK)
- K050532 — CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WA
- K050527 — POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 200 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABL
- K050529 — POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTER
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.