Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (White) +1 more— 510(k) K162405
Substantially EquivalentComfort Rubber Gloves Industries Sdn. Bhd.
FDA 510(k) clearance K162405 for Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (White) +1 more, Substantially Equivalent on 2017-03-28. Applicant: Comfort Rubber Gloves Industries Sdn. Bhd.. Device class: 1.
Clearance details
- Device name as filed
- Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (White); Powder Free Nitrile Examination Gloves Tested For Use With Chemotherapy Drugs Labeling Claim (Blue)
- Applicant
- Comfort Rubber Gloves 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
- Matang, MY
Recent devices under product code LZA
view all- K261793 — Powder-free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs and Fentanyl Citrate (Blue and Black Color)
- 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 Comfort Rubber Gloves Industries Sdn. Bhd.
view all- K250069 — Powder Free Natural Rubber Latex Examination Gloves Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein
- K240269 — Nitrile Powder Free Examination Gloves Biodegradable (Green)
- K241528 — Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential
- K192954 — Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl
- K200181 — Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
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.