CASHMERE POWDER FREE NITRILE EXAMINATION GLOVES— 510(k) K042101
Substantially EquivalentSeal Polymer Industries Bhd.
FDA 510(k) clearance K042101 for CASHMERE POWDER FREE NITRILE EXAMINATION GLOVES, Substantially Equivalent on 2004-08-27. Applicant: Seal Polymer Industries Bhd.. Device class: 1.
Clearance details
- Applicant
- Seal Polymer Industries 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
- Lahat, Perak, MY
Recent devices under product code LZA
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- 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 Seal Polymer Industries Bhd.
view all- K042238 — CASHMERE POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES
- K032077 — CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (VIOLET)
- K022792 — CASHMERE POWDER FREE LATEX EXAMINATION GLOVES (POLYMER COATED ONLINE CHLORINATED)
- K021388 — CASHMERE NON-STERILE, POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRAM
- K020868 — CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (WHITE)
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.