RS SAFE BLUE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)— 510(k) K100603
Substantially EquivalentRiverstone Resources Sdn Bhd
FDA 510(k) clearance K100603 for RS SAFE BLUE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE), Substantially Equivalent on 2010-07-16. Applicant: Riverstone Resources Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Riverstone Resources 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
- 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 Riverstone Resources Sdn Bhd
view all- K220672 — Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim
- K220401 — Pink Powder Free Nitrile Examination Glove With Bubblegum Scented, Chemotherapy Drugs And Fentanyl Test Claim
- K200326 — Powder Free Nitrile Examination Glove (Aqua Green)
- K190725 — Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White
- K180452 — White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim
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 K100603
K-number listed on FDA's recall record- Z-1203-2016 — Covidien Dover KIT/STERILE PRESERVE CULT Item Code: 8000SA Castile soap towelettes are used to clean the genital area for male and female patients
- Z-1206-2016 — Covidien Dover PREM U/M 14FR SLVR FLY Item Code: P4P14XSD P400 Castile soap towelettes are used to clean the genital area for male and female patients
- Z-1208-2016 — Covidien Dover P400 UM 16FR SIL COUDE SECURE Item Code: P4P16CSDK Castile soap towelettes are used to clean the genital area for male and female patients
- Z-1209-2016 — Covidien Dover P400 PREM U/M 16FR SIL FLY Item Code: P4P16SD Castile soap towelettes are used to clean the genital area for male and female patients
- Z-1210-2016 — Covidien Dover P400 PREM U/M 16FR TMP SNS CSD Item Code: P4P16TSD Castile soap towelettes are used to clean the genital area for male and female patients
- Z-1211-2016 — Covidien Dover P400 PREM U/M 16FR UL FOLY CSD Item Code:P4P16ULD Castile soap towelettes are used to clean the genital area for male and female patients
- Z-1212-2016 — Covidien Dover P400 PREM U/M 16FR SLVR FLY Item Code: P4P16XSD Castile soap towelettes are used to clean the genital area for male and female patients
- Z-1213-2016 — Covidien Dover P400 PREM UM 16FR SILV TMP CSD Item Code: P4P16XTSD Castile soap towelettes are used to clean the genital area for male and female patients
- Z-1214-2016 — Covidien Dover P400 PREM U/M 18FR SIL COUDE CATH SECURE Item Code: P4P18CSD Castile soap towelettes are used to clean the genital area for male and female patients
- Z-1215-2016 — Covidien Dover P400 UM 18FR SIL COUDE SECURE Item Code: P4P18CSDK Castile soap towelettes are used to clean the genital area for male and female patients
- Z-1216-2016 — Covidien Dover P400 PREM U/M 18FR SIL FLY Item Code: P4P18SD Castile soap towelettes are used to clean the genital area for male and female patients
- Z-1217-2016 — Covidien Dover P400 PREM U/M 18FR UL FOLY CSD Item Code: P4P18ULD Castile soap towelettes are used to clean the genital area for male and female patients
- Z-1218-2016 — Covidien Dover ¿18 FR/CH SILVER-HYDROGEL COATED SILICONE FOLEY CATHETER WITH COUD¿ TIP PRE-CONNECTED TO 400 ML URINE METER WITH 2000 ML DRAINAGE BAG WITH ADHESIVE CATHETER SECUREMENT AND OTHER STANDARD TRAY COMPONENTS INCLUDING HAND SANITIZER AND SKIN BARR Item Code: P4P18XCSDK¿¿¿¿ Castile soap towelettes are used to clean the genital area for male and female patients
- Z-1219-2016 — Covidien Dover 400 PREM U/M 18FR SLVR FLY Item Code: ¿¿¿ P4P18XSD Castile soap towelettes are used to clean the genital area for male and female patients
- Z-1220-2016 — Covidien Dover PRECSION PRM 14FR SIL FLY Item Code: ¿ PP14SD ¿¿ Castile soap towelettes are used to clean the genital area for male and female patients
- Z-1221-2016 — Covidien Dover PREC PRM 14FR SILVER FLY TY Item Code: PP14XSD ¿ ¿¿ Castile soap towelettes are used to clean the genital area for male and female patients
- Z-1222-2016 — Covidien Dover PRECISION PRM 16FR SIL COUDE CATH SECURE Item Code: PP16CSD Castile soap towelettes are used to clean the genital area for male and female patients
- Z-1223-2016 — Covidien Dover PRECSION PRM 16FR SIL FLY Item Code: PP16SD Castile soap towelettes are used to clean the genital area for male and female patients
- Z-1224-2016 — Covidien Dover PREM 16FR UL LTX FOLEY TRY CSD Item Code: PP16ULD Castile soap towelettes are used to clean the genital area for male and female patients
- Z-1225-2016 — Covidien Dover PREC PRM 16FR SILVER FLY TY Item Code: PP16XSD Castile soap towelettes are used to clean the genital area for male and female patients
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K100603.
Data sourced from openFDA. This site is unofficial and independent of the FDA.