Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drugs; Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, White Tested For Use with 32 Chemotherapy Drugs— 510(k) K222993

Substantially Equivalent

Sentienx Sdn Bhd

FDA 510(k) clearance K222993 for Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drugs; Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, White Tested For Use with 32 Chemotherapy Drugs, Substantially Equivalent on 2023-08-18. Applicant: Sentienx Sdn Bhd.

Clearance details

Applicant: Sentienx Sdn Bhd
Product code: Code KGO
Advisory panel: General, Plastic Surgery
Date received: 2022-09-28
Decision date: 2023-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kulim, MY

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.