Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove— 510(k) K183389
Substantially EquivalentHartalega NGC Sdn. Bhd.
FDA 510(k) clearance K183389 for Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove, Substantially Equivalent on 2019-06-28. Applicant: Hartalega NGC Sdn. Bhd.. Device class: 1.
Clearance details
- Applicant
- Hartalega NGC 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
- Sepang, 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 Hartalega NGC Sdn. Bhd.
view all- K254285 — Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs Aqua Blue +3 more
- K260867 — Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) +1 more
- K250861 — Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black)
- K251319 — Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) +1 more
- K243818 — Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
Data sourced from openFDA. This site is unofficial and independent of the FDA.