NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN COLOR— 510(k) K990453
Substantially EquivalentAlliance Rubber Products Sdn. Bhd.
FDA 510(k) clearance K990453 for NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN COLOR, Substantially Equivalent on 1999-03-09. Applicant: Alliance Rubber Products Sdn. Bhd.. Device class: 1.
Clearance details
- Applicant
- Alliance Rubber Products 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
- Nibong Tebal, Pulau Pinang, 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 Alliance Rubber Products Sdn. Bhd.
view all- K002701 — POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN LABELING CLAIM. (50 MICROGRAMS OR LESS)
- K992870 — POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES LABELING CONTENT: 100 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEI
- K991981 — NITRILE EXAMINATION GLOVES, NON-STERILE, POWDER FREE, DARK BLUE COLOR
- K990427 — ARSOFT NITRILE EXAMINATION GLOVES, NON-STERILE POWDER FREE
- K990485 — NITRILE EXAMINATION GLOVES, NON-STERILE, POWDERED, GREEN COLOR
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.