Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs— 510(k) K171898
Substantially EquivalentBetter Care Plastic Technology Co., Ltd.
FDA 510(k) clearance K171898 for Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs, Substantially Equivalent on 2017-08-18. Applicant: Better Care Plastic Technology Co., Ltd.. Device class: 1.
Clearance details
- Applicant
- Better Care Plastic Technology Co., Ltd.
- 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
- Shenze County, CN
Recent devices under product code KGO
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- K240790 — Polyisoprene Surgical gloves
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More clearances from Better Care Plastic Technology Co., Ltd.
view all- K242533 — Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- K232266 — Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- K232070 — Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green)
- K231567 — Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and select other drugs (Blue)
- K223713 — Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
Data sourced from openFDA. This site is unofficial and independent of the FDA.