플렉스용 Surgical Powder Free 손가락 장갑, 피부염 가능성 낮음 주장, 녹색 13종 화학요법 약물 사용 시 테스트; 플렉스용 Surgical Powder Free 손가락 장갑, 피부염 가능성 낮음 주장, 흰색 32종 화학요법 약물 사용 시 테스트

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 is a medical device that received FDA 510(k) clearance on 2023-08-18. The listed applicant is Sentienx Sdn Bhd. The 510(k) number is K222993.

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 received FDA 510(k) clearance on 2023-08-18, under 510(k) number K222993.

The FDA 510(k) record lists Sentienx Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

The FDA product code 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 is KGO.