Sterile Latex Surgical Glove, Powder Free— 510(k) K190241
Substantially EquivalentCareglove Global Sdn. Bhd.
FDA 510(k) clearance K190241 for Sterile Latex Surgical Glove, Powder Free, Substantially Equivalent on 2019-12-30. Applicant: Careglove Global Sdn. Bhd.. Device class: 1.
Clearance details
- Applicant
- Careglove Global Sdn. Bhd.
- Product code
- Code KGO
- Device class
- Class 1
- Regulation
- 21 CFR 878.4460
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seremban, MY
Recent devices under product code KGO
view all- K260558 — Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate +1 more
- K253060 — Sterile Latex Powder Free Surgical Gloves
- K250313 — Sterile Powder Free Synthetic Rubber Surgeons Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid
- K240790 — Polyisoprene Surgical gloves
- K232079 — Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green) +1 more
More clearances from Careglove Global Sdn. Bhd.
view all- K250578 — Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)
- K230121 — Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)
- K220859 — Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black)
- K213993 — Powder Free Chloroprene Examination Glove Coloured (Blue, Green)
- K211666 — Powder Free Nitrile Examination Gloves, Blue Chemotest
Data sourced from openFDA. This site is unofficial and independent of the FDA.