COMFIT CHEMO PLUS POWDER FREE BLUE NITRILE EXAMINATION GLOVES, NON STERILE (TESTED FOR USE WITH CHEMOTHERAPY DRUG) LABEL— 510(k) K002064
Substantially EquivalentWrp Asia Pacific Sdn. Bhd.
FDA 510(k) clearance K002064 for COMFIT CHEMO PLUS POWDER FREE BLUE NITRILE EXAMINATION GLOVES, NON STERILE (TESTED FOR USE WITH CHEMOTHERAPY DRUG) LABEL, Substantially Equivalent on 2000-11-28. Applicant: Wrp Asia Pacific Sdn. Bhd.. Device class: 1.
Clearance details
- Applicant
- Wrp Asia Pacific 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
- Salak Tinggi, Sepang Selangor, 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 Wrp Asia Pacific Sdn. Bhd.
view all- K232079 — Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green) +1 more
- K232538 — DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL
- K230578 — Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl
- K222058 — Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant
- K211601 — Powder Free Latex Examination Glove, Non-Sterile
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 →
Recalls naming K002064
K-number listed on FDA's recall record- Z-1078-2021 — Covidien ChemoPlus Chemo Spill Kit, Nonsterile, SKU DP5108K
- Z-1079-2021 — CHEMOBLOC Preparation and Administration Kit, Extra Large Blue Gown, Medium and Large Gloves, Nonsterile, SKU DP5106K
- Z-1081-2021 — ChemoPlus Drug Spill Kit-INSTI, SKU DP5016K
- Z-1283-2019 — ChemoPlus Chemo Spill Kit Product Code:CT4004 Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills
- Z-1284-2019 — ChemoPlus Chemo Spill Kit Product Code:DP5016K Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills
- Z-1285-2019 — ChemoPlus Protective Wrap-around Goggles Product Code:DP5030G Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills
- Z-1286-2019 — ChemoPlus Chemo Spill Kit, Home Health Kit Product Code:DP5108K Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K002064.
Data sourced from openFDA. This site is unofficial and independent of the FDA.