POWDER NITRILE EXAMINATION GLOVE (WHITE AND BLUE COLOR)— 510(k) K063522
Substantially EquivalentHl Rubber Industries Sdn Bhd
FDA 510(k) clearance K063522 for POWDER NITRILE EXAMINATION GLOVE (WHITE AND BLUE COLOR), Substantially Equivalent on 2007-02-08. Applicant: Hl Rubber Industries Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Hl Rubber Industries 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
- Kuala Pilah, Negeri Sembilan, 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 Hl Rubber Industries Sdn Bhd
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.