KIMBERLY-CLARK STERLING NITRILE POWDER-FREE EXAM GLOVE (STERILE)— 510(k) K081027
Substantially EquivalentKimberly-Clark Corp.
FDA 510(k) clearance K081027 for KIMBERLY-CLARK STERLING NITRILE POWDER-FREE EXAM GLOVE (STERILE), Substantially Equivalent on 2008-06-30. Applicant: Kimberly-Clark Corp.. Device class: 1.
Clearance details
- Applicant
- Kimberly-Clark Corp.
- 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
- Abbreviated
- Location
- Roswell, GA, US
Recent devices under product code LZA
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- 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 Kimberly-Clark Corp.
view allAdverse 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 →
Recalls naming K081027
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K081027.
Data sourced from openFDA. This site is unofficial and independent of the FDA.