NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST— 510(k) K162858
Substantially EquivalentCareplus (M) Sdn Bhd
FDA 510(k) clearance K162858 for NITRILECARE NITRILE EXAMINATION GLOVES POWDER FREE, BLUE, CHEMOTEST, Substantially Equivalent on 2017-07-24. Applicant: Careplus (M) Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Careplus (M) Sdn Bhd
- Product code
- Code LZC
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seremban, MY
Recent devices under product code LZC
view all- K252313 — Cardinal Health Nitrile Examination Gloves Extended Cuff
- K243959 — Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs
- K221157 — JR Medic
- K222449 — Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue)
- K220545 — Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs
More clearances from Careplus (M) Sdn Bhd
view all- K211621 — Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less)
- K201857 — Powder Free Nitrile Examination Glove Black and Dual Color White-Blue
- K203705 — Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein)
- K210724 — ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Standard, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs
- K210656 — ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50 µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs
Data sourced from openFDA. This site is unofficial and independent of the FDA.