Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White)— 510(k) K250496
Substantially EquivalentZibo Shengkun Chemical Industry Co., Ltd.
FDA 510(k) clearance K250496 for Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White), Substantially Equivalent on 2025-07-07. Applicant: Zibo Shengkun Chemical Industry Co., Ltd.. Device class: 1.
Clearance details
- Applicant
- Zibo Shengkun Chemical Industry Co., Ltd.
- 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
- Zibo, CN
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
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.